2025 Archives

Innovations in Clinical Trial Design for CNS Disorders

Clinical research in central nervous system (CNS) diseases has long been fraught with challenges. High failure rates, complex pathophysiology, variability in disease progression, strong placebo effects, and difficulties in recruitment and outcome measurement have made CNS disorders one of the riskiest areas for drug development. However, recent innovations in trial design — coupled with advances in digital health and statistical modelling — are transforming how we conduct clinical research in diseases like Huntington’s disease (HD), Alzheimer’s disease (AD), and multiple sclerosis (MS). This blog explores three recent trials that exemplify these innovations and proposes statistical advancements to strengthen their impact.

Adaptive designs in Huntington’s disease: The PIVOT-HD trial

Traditional fixed designs often struggle to efficiently explore dose-response relationships or adapt to emerging data. Adaptive trial designs offer a dynamic solution, particularly valuable in neurodegenerative diseases like Huntington’s disease, where treatment response and disease progression can vary widely.

Case study: PIVOT-HD trial (NCT05358717)

The PIVOT-HD trial, led by PTC Therapeutics, is a Phase II adaptive study evaluating the safety, pharmacodynamics, and early signs of efficacy of PTC518, a novel small-molecule HTT-lowering therapy. PTC518 modulates mRNA splicing to reduce levels of the mutant huntingtin protein, a key driver of HD pathology.

What sets this trial apart is its seamless adaptive design. The trial is structured to adjust dosing and the randomization ratios based on interim pharmacodynamic and safety readouts. By incorporating planned decision-making, PIVOT-HD minimizes exposure to ineffective doses and accelerates identification of promising therapeutic windows.

Digital biomarkers and remote monitoring in Alzheimer’s disease: The DETECT-AD trial

Cognitive decline in AD is insidious and can be difficult to quantify with infrequent clinic visits and subjective tests. Digital health technologies are revolutionizing outcome assessment through continuous, objective, and sensitive data collection.

Case study: DETECT-AD (Digital Evaluations and Technologies Enabling Clinical Translation in Alzheimer’s Disease)

The DETECT-AD initiative, part of a broader effort supported by the NIH and multiple research institutions, is employing wearables, mobile apps, and speech analysis to detect early signs of Alzheimer’s disease in at-risk populations.

In the DETECT-AD observational study, participants use smartphone apps and passive sensors to monitor activities like walking, typing speed, and even voice characteristics. These digital biomarkers are being correlated with traditional cognitive assessments and brain imaging data to predict cognitive decline before clinical symptoms emerge.

Platform trials in multiple sclerosis: The OCTOPUS trial

In diseases like MS, where multiple mechanisms may underlie relapses and progression, traditional “one drug, one trial” designs are increasingly inefficient. Platform trials offer a more flexible and scalable solution.

Case study: The OCTOPUS trial (UK MS Society)

The OCTOPUS (Optimal Clinical Trials Platform for Progressive MS) trial is the world’s first multi-arm, multi-stage platform trial in progressive MS. Spearheaded by the UK MS Society, this innovative study aims to test multiple repurposed therapies simultaneously, using a shared control group and adaptive design principles.

OCTOPUS promises faster answers with fewer patients and more efficient use of resources, particularly crucial in progressive MS where effective treatments are lacking.

Statistical challenges and opportunities

Despite these advances, several statistical hurdles remain. Novel designs require equally innovative statistical approaches to preserve validity and ensure robust interpretation.

Broader adoption of Bayesian statistical frameworks

Bayesian approaches allow the integration of prior knowledge (e.g., historical control data or early biomarkers) and offer probabilistic interpretations of trial results. In adaptive and platform trials, Bayesian methods facilitate:

Interim analyses with posterior probabilities guiding adaptations.
Dynamic borrowing from concurrent or historical control arms.
Greater flexibility in endpoint modelling across heterogeneous subgroups.

For example, the GBM AGILE platform trial in glioblastoma (a CNS tumor) successfully uses Bayesian methods to adapt enrollment and determine early stopping rules. A similar framework could benefit complex CNS conditions like MS or AD, where responses are highly individualized.

Incorporating real-world evidence (RWE) in trial planning and analysis

As clinical trials increasingly occur alongside large electronic health record (EHR) systems, real-world data (RWD) can inform trial design and enhance external validity. Specifically:

RWD can help refine eligibility criteria to better represent actual patient populations.
Real-world comparators can augment underpowered control groups or offer external validation.
Longitudinal RWE provides insight into long-term treatment effects beyond trial duration.

In Alzheimer’s disease, initiatives like the AHEAD 3-45 study are already incorporating observational cohorts and RWE in trial simulation and endpoint modelling.

The next generation of neuroscience trials

The future of CNS clinical trials is increasingly adaptive, digital, and data driven. Innovative designs like PIVOT-HD, DETECT-AD, and OCTOPUS illustrate the power of new methodologies to make trials more efficient, sensitive, and patient-centric. However, to fully realize their potential, we must integrate robust statistical techniques such as Bayesian modelling and real-world data frameworks. These tools will help overcome inherent complexities in CNS research and bring transformative treatments closer to patients in need.

As we look ahead, collaboration between statisticians, clinicians, regulators, and technology developers will be essential in shaping the next generation of neuroscience trials — where precision, agility, and real-world relevance are no longer luxuries, but necessities.

Interested in learning more?

Register now to watch James Matcham’s on-demand webinar, “Clinical Trial Design Innovation in CNS Disorders.” This webinar features a review of regulatory guidelines and showcase recent successful trials in Alzheimer’s disease and other neurological disorders.

Career Perspectives: A Conversation With Lisa Svensson

In this edition of our Career Perspectives series, we had the pleasure of interviewing Lisa Svensson, Principal Consultant Clinical Project Management at Cytel Sweden. With a background in medical sciences and experience ranging from clinical research to science journalism, she shares insights into her professional path, the dynamic nature of her current role, and the value of stepping outside one’s comfort zone.

Can you give us a little background on your career so far? What inspired you to pursue a master’s degree in medical sciences, and how did that lead to your first jobs as a Clinical Research Associate?

Science — and especially human biology — has always fascinated me. During high school I focused on science subjects, which made choosing my university studies easy. I initially pursued engineering in biotechnology but later shifted my focus entirely to medical science, eventually earning my master’s degree in that field.
In the last six months before completing my degree, I took a course in clinical trials, which first sparked my interest in the subject. However, I was not entirely convinced at the time and initially pursued a career in academia. Later, I got an opportunity when a friend recommended me for a position as a Clinical Research Associate at a small company in Uppsala. I quickly felt at home and was fortunate to join a workplace that valued independence and trust. Plus, it was a lot of fun.
During my first year, I gained experience in all aspects of clinical trials. I was even involved in designing electronic Case Report Forms (eCRFs). The work environment was excellent, and I truly enjoyed my time there. I especially liked working closely with sponsors, often small companies filled with passionate and engaged people.

Alongside your role as a Clinical Research Associate, you also worked as a Science Journalist for Swedish TV for a year. How did that opportunity come about, and what was that experience like? How did it complement or contrast with your work in clinical research?

I think I have a curious mind and a passion for learning. I took a year off from work and pursued a fast-track journalism program, earning a degree in the field. This was before I had my own family, and I thought about it as a “now or never” opportunity. As part of the program, I applied for a six-month internship with the Swedish TV science program Vetenskapens Värld — and was thrilled to be accepted. Following the internship, I continued working as a science reporter for another six months, gaining invaluable hands-on experience. I worked with their website, delivering science news daily. I also worked directly with the TV shows, producing two larger segments with different topics — including one on children and sports, and the significant difference being born early or late in the year can make.

Compared to the world of clinical trials with a lot of regulations, working in media is much more flexible. I was completely out of my comfort zone, but I also learned a lot. I think most of the things it taught me are still applicable in my work today. It is always beneficial to learn how to communicate well and get your message through. Stepping out of your comfort zone is also an experience, although it might feel scary at the time. Honestly, I was a bit stressed, but it was also a lot of fun.

You started at SDS Life Science in 2021 and became part of Cytel, following its acquisition. How was that transition for you, and what were the biggest adjustments to working within a larger organization?

I have experience working in large organizations, including Contract Research Organizations (CROs), so transitioning to a bigger company was not unfamiliar to me. Before joining Cytel, I worked at Medtronic, another large American company, and many of the processes at Cytel were similar to what I was already accustomed to.

In terms of my daily work, the transition didn’t bring significant changes. Although being part of a larger organization changes the dynamics, it also creates other possibilities. Now, I have the opportunity to work with people from other departments such as Project Based Solutions (PBS), and I have met a lot of skilled and competent people.

You are now a Principal Consultant Clinical Project Management at Cytel. What does your function entail? Could you walk us through a typical workday?

As a consultant in Clinical Project Management, I help clients with the sponsor oversight of their trials, ensuring adherence to Good Clinical Practice as well as making sure that the reported data is of high quality. I act as the primary contact between the sponsor and the CRO and collaborate closely with the CRO’s counterpart in project management. I also facilitate communication across the project, especially between cross-functional teams such as statisticians, data managers, and other key stakeholders.

As a clinical project manager, it is essential to have proper training in both medical science and clinical trials to be able to adhere to regulatory requirements while also being able to understand the clinical part of the projects. I think that is the most important aspect of being a clinical project manager.

For our clients, sponsor oversight is also key to a successful project. If you do not diligently oversee your trial, while it is ongoing, it can be detrimental to your project. Having proper sponsor oversight is also a requirement within ICH-GCP E6.

I wouldn’t say that I have a typical workday, as it largely depends on current priorities. However, my work involves a great deal of problem-solving, structuring workflows, and frequent emailing to stay updated on the project’s status. The scope of work also varies depending on where the client is on their journey.

During the start-up phase of a trial, my focus is on laying a strong foundation — either by helping to select the most suitable CRO or by working with the chosen vendor to establish proper processes and solid study plans. So, the daily work could involve either attending bid-defense meetings at the start of a project or spending a lot of time reviewing or possibly even writing study plans.

As the trial progresses into the middle stages, my role shifts towards extensive follow-up and quality control to maintain efficiency and compliance. Overall, my daily work involves a lot of meetings and status updates via email.

What do you enjoy most about your role, and about working at Cytel?

Working with sponsor oversight often means a close collaboration with the sponsor and you therefore easily become “part of their team”. That is something I really enjoy.

You also get the privilege to deep dive into a project and learn a lot about a specific area or therapy which is very interesting. I like the variety that my role includes. You can go from one project in oncology to another that has a completely different therapy in focus or even a device instead of drug. The variety is what is the most interesting, and I enjoy the challenge of being a problem solver. I’m passionate about what I do.

I am especially happy during my current project, which has grown from solely sponsor oversight and statistics to involve many people at Cytel Sweden and within our PBS team. My colleagues are great at what they do, which makes working together on this project incredibly enjoyable.

Your job not only requires a keen understanding of clinical trials, but also collaboration and communication. Are there any other skills you believe are required to succeed in this role?

As mentioned, my role involves a great deal of cross-functional collaboration. I guess you could say that as a clinical project manager, I am more of a generalist than a specialist, and I truly enjoy working that way. Two key skills you mentioned — collaboration and communication — are essential, but I believe that prioritization and structured work are equally important. In high-pressure projects where timelines are critical, it’s crucial to take a step back, adopt a broader perspective, and focus on what is most important in that moment.

Your role involves working from our office, our client’s office, and remotely. How do you maintain work-life balance while switching between these environments? Do you still feel you have flexibility in your schedule?

I have 2 small kids at home (6 and 3 years old) and they keep me busy when I am not at work. Just like many other people, I am juggling a schedule that includes dropping the kids off to pre-school and rushing off to get into the office (or the client’s office).

I love Cytel’s Stockholm office central location, which helps a lot when commuting to town. I also think that there is flexibility when you are not required to come into the office 5 days a week. It helps to keep the life-work balance. Recently I bought an e-bike which is very convenient! I live about 17 km from the office one way so having a motor to support my cycling is nice.

Finally, when you’re not diving into work, what hobbies or passions keep you busy?

Well, as I said, I think my two kids keep me rather busy. I also live in a house with a garden that requires a bit of work, although that is currently not a top priority. If I had more time however, I would like to be more outdoors, since I really enjoy cycling, kayaking and climbing. During winter, my top hobby is cross-country skiing. I live close to the ocean, so I have promised myself to bring out my stand-up paddleboard more often. Last summer, I managed to get out on the board twice in the early morning to get some exercise in — or, as it turned out, just to sit and enjoy the view.

Thank you, Lisa, for sharing your experience!

Strategies to Streamline the MHRA Inspection Process

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) plays a critical role in ensuring the safety, quality, and efficacy of medicines and medical devices. MHRA inspections are often a key step in bringing new therapies to market, but poor preparation can result in delays or regulatory setbacks.

Here, we outline the types of MHRA inspections, provide an overview of the essential steps and documents, and discuss challenges and how to overcome them to streamline your MHRA inspection process.

Types of MHRA inspections

There are two main MHRA inspection types. They include:

Statutory Good Clinical Practice (GCP) Inspection (a “routine” inspection): This inspection is performed as part of the risk-based compliance program and can be either systems-based or trial specific. Inspectors examine how an organization’s trial procedures are applied, considering previous inspection history, organizational changes, or intelligence from other external sources. Sponsors are usually notified six months ahead of time.

Triggered Inspection: Triggered inspections are initiated by concerns regarding a clinical trial’s conduct, often from sources like serious breach notifications, whistleblowers, or other MHRA departments. The nature of the information determines the level of notice provided, which may be short or none at all.

Essential steps and documents

The MHRA inspection process consists of three primary phases: planning, inspection, and reporting.

In the planning phase, sponsors receive an “Advance Notice of Statutory Inspection” notification, prepare an Inspection Dossier, and develop an Inspection Plan.

The inspection phase involves the main site inspection.

The reporting phase comprises issuing an Inspection Report and identifying Corrective and Preventive Actions (CAPA).

Strategies to streamline the inspection process

Apply the framework for engagement

Define clear duties and responsibilities, emphasize collaboration, and foster productive dialogue. This approach includes four considerations: steering group and communication, resource management and flexibility, documentation, preparation and strategic output. (We will discuss this framework in detail in our upcoming webinar, click the link below to register).

Prepare supportive documents

Create supportive documents that enable quick access to detailed and precise information during high-pressure situations, enhance understanding of the procedures and trial materials under review, and prepare tools and responses for anticipated critical discussion points.

Ensure staff is adequately trained

Mandatory training on current and historical versions of quality assurance documents, including SOPs, WIs, and related tools, is required to ensure understanding of both current processes and those used at the time of production of the deliverables for each study inspected.

Use live demos or “show and tell” sessions

Live demos can help visualize the process and ensure it is understood by the inspector as well as provide the opportunity to delve into the details.

Final takeaways

Navigating MHRA inspections requires a proactive approach, strategic preparation, and a deep understanding of evolving regulatory expectations. By leveraging innovative strategies, organizations can streamline their inspection readiness and enhance compliance outcomes. Equally crucial is the establishment of a well-defined framework that fosters effective collaboration among all stakeholders — sponsors and key vendors alike — ensuring a streamlined and coordinated approach to the inspection process.

Want to learn more?

Join Stephanie Dontenville and Nicolas Rouillé for their upcoming webinar to gain practical insights from Cytel’s MHRA inspection experience. Learn how to prepare thoroughly, execute precisely, and turn post-inspection feedback into innovation.

Advancing Clinical Trials Through Shared Expertise and Collaboration

Working across a range of Phase I, II, and III trials as well as numerous possible indications, our Project-Based Services (PBS) teams have specialists in many areas. In order to enhance expertise among colleagues, foster knowledge-sharing, and stay up to date on recent developments in the field, Cytel has developed a collaborative workstream initiative that brings together experts with shared statistical and therapeutic area interests.

Michaela Šedová, Biostatistics Director with PBS, moderates the neurology workstream. In this interview, Michaela discusses how these initiatives enable colleagues to share and grow their experience and skills, and how this behind-the-scenes work benefits sponsors.

Michaela, what inspired the creation of Cytel’s new workstreams that focus on specific therapeutic areas and methodologies?

We are a team of biostatisticians working within Cytel PBS. Most of our contracts are limited to specific projects, typically involving one or several related studies. This means that we handle a diverse range of trials — be it Phase I, II, or III, and on any possible indication. Our work includes trials conducted by small biotech companies that lack in-house statisticians, requiring substantial methodological and statistical input from our team, and from large pharmaceutical companies with more specific and focused requirements.

Given the wide range of disease areas, statistical methodologies, and operational aspects we encounter, it’s impossible to be experts in every domain. Instead, we tend to specialize in certain areas. The workstream initiative brings together colleagues with shared statistical and therapeutic area interests and provides a platform to share recent developments, enhance expertise, and foster knowledge-sharing within the company.

Companies sometimes overlook the wealth of experience and skills their employees possess, simply because they lack opportunities to use them. At Cytel, our workstream initiative helps us uncover such talents and foster expertise in specialized methodological and therapeutic areas.

Could you walk us through the focus of these new workstreams, and share some of the key activities involved?

Cytel PBS has set up workstreams focused on varied disease indications (neurology, oncology, type 2 diabetes/cardiovascular) and methodological aspects or regulatory know-how (statistical methodology, rare diseases, Phase I studies, submissions of new drug applications).

The objectives of the workstreams vary depending on their focus, though they all follow recent developments in their field and corresponding regulatory guidelines. Some workstreams have started creating internal standards (e.g., SAPs, table shells) and trainings to support other statisticians, or have documented experiences with specific statistical methods. The objective is to centralize the information and build a structured way of knowledge-sharing.

Workstream meetings and groups are an ideal forum to discuss specific topics and share opinions with colleagues. Some workstreams are also involved in sales and optimization initiatives. Externally, workstream members may attend and prepare presentations for conferences or workshops.

How do these workstreams integrate with the existing clinical biometrics services we offer?

Each statistician within PBS has the opportunity to contribute to one or more workstreams. It is a platform that helps to provide peer-to-peer support among individuals involved in specific projects. Overall, the workstreams aim to support and to improve our existing services.

How do our clients benefit from these workstreams?

At the request-for-proposal stage, clients are often interested in our experience within a specific topic. The workstreams help not only to summarize and provide feedback on such experiences, but within the platform, we can develop and maintain shared knowledge at the highest level within that particular area. We can easily ensure stability, suitable study specific assignments, and swift back-ups, if needed. Additionally, less-experienced statisticians — whether junior or new to the field — gain the broader support provided by the workstream, offering them guidance. Consequently, our clients benefit from this direct and indirect therapeutic area and methodology expertise.

Now, you moderate the neurology workstream. Can you share some of your activities?

The neurology workstream has two main areas of interest:

Multiple sclerosis (MS)
Alzheimer’s disease/Parkinson’s disease

These diseases are complex, which is why it’s essential to understand their etiology, development, and symptoms to comprehend typical endpoints and analyze them appropriately. Therefore, we have prioritized mapping, maintaining, and expanding the expertise we have gained through collaborations with various clients, primarily well-established pharmaceutical companies that have already marketed several products and are developing other compounds, as well as smaller biotech companies. The neurology workstream has created a few sets of training slides for biostatisticians who are new to the indication. We also collaborate with Cytel’s business development department on a better description of our capability for clients.

Could you be more specific and share examples?

For now, the focus is on MS and Alzheimer’s/Parkinson’s disease endpoints and statistical methodologies used to analyze them. Team members often bring varied experiences to each focus area. For instance, some colleagues have conducted numerous analyses on relapses, which are recurrent events that may require “qualification” or can have different competing risks — aspects that potentially need to be considered in the analysis. Another example is composite endpoints, such as NEDA (no evidence of disease activity), where different clients may adopt slightly different approaches. Additionally, we work with tools designed to measure levels of disability, cognitive function, and patient-reported outcomes (PROs) collected through questionnaires. These are typically repeated measures, analyzed based on specific manuals.

Can you share an example of a client engagement where your workstream made an impact?

The workstreams operate behind the scenes. For instance, we have long-term clients for which we run numerous exploratory analyses in the medical affairs area. These are often requested on short notice and are difficult to plan. The workstream enables us to remain flexible, distributing the workload among several team members and involving colleagues who would otherwise require significantly more time for onboarding.

Metrics to Assess Clinical Trial Design Strength

The probability of success of a study is a critical metric in assessing the viability of a study design. In simple trial designs, probability of success can be defined as the study’s statistical power. However, more nuanced definitions of success are available, including some that incorporate assumptions of multiplicity (multiple study arms or multiple endpoints), and uncertainties about the true underlying treatment effect. Assurance is one such Bayesian concept, considering potential variability in treatment effect assumptions.

What is study power?

It is the conditional probability of rejecting your null hypothesis given an assumed treatment effect.

What is assurance?

One way of defining assurance is the expected power across different treatment effect assumptions. Assurance is especially useful when there is uncertainty around the treatment effect. Rather than calculate power based on a single assumption, we can calculate the power across a series of assumptions, and assurance is the average of the power across all scenarios.

In addition, if some information is available about the likelihood of each of these treatment effect scenarios prevailing, it can be incorporated in this calculation to produce a more realistic expectation of results. In this case, each treatment effect scenario is assigned a likelihood, and this likelihood is included in the assurance calculation. This process gives more weight to the scenarios that are more likely to be the true treatment effect.

Cytel has incorporated both concepts — power and assurance — into its East Horizon^TM platform. As well-established metrics in clinical trial design practice, these are widely used in the trial design process. In addition, Cytel has developed two related concepts to power and assurance, performance score and robustness score, to enhance the process of design, offer two additional metrics for assessment, and to elevate the role of the statistician as a strategic thinker in clinical development practice. These two metrics are also embedded in Cytel’s software.

What is the performance score?

The performance score is a linear weighted function that allows the statistician to integrate strategic priorities (reduction in sample size, reduction in duration, and increase in probability of success) into the clinical trial design process. The statistician can assign weights representing the importance of each strategic priority in assessing a study design, and the resulting score provides an estimate of the relative desirability of a design based on these priorities. Thus, the performance score provides an additional metric by which to assess the viability of a study design.

The weighted function of these performance criteria is:

What is the robustness score?

Like the concept of assurance, the robustness score is the average of the performance scores across different treatment effect assumptions. If there is uncertainty about the treatment effect, the robustness score takes that potential variability into account.

Here too, if some prior information about the likelihood of treatment effect scenarios is available, it can be incorporated in the calculation of the robustness score to produce a more nuanced expression of robustness, based on the strategic priorities set by the drug development team. If no prior information is available, each scenario automatically gets assigned equal likelihood.

These four concepts together, power, assurance, performance, and robustness scores, are key tools in the statistician’s toolbox for clinical trial design. Crucially, the latter two metrics are a shift in the statistician’s mindset from a purely scientific consideration of trial design, to incorporating strategic thinking in the design process. In addition, the scoring mechanism allows statisticians to identify a multitude of designs that satisfy basic statistical criteria and choose from among those the best-suited design based on strategic priorities. Finally, the score is a powerful communication tool, anchoring the statistician at the center of the discussion about tradeoffs in priorities in the design selection process with a wider cross-functional team.

In this way, the scoring mechanism embedded in East Horizon has transformed the software from a purely statistical design and analysis tool (albeit nuanced and powerful) to a clinical design strategy tool with a solid and potent statistical core. As more life sciences organizations adopt East Horizon and the advanced design tools it affords, we are seeing a gradual shift in the function of the statistician’s role within these organizations to a more central and consultative role in the trial design process.

Offshoring Biometrics FSP Teams: Best Practices

Functional Service Provider (FSP) models are widely used to deliver biometrics services in the biopharmaceutical industry. Traditionally, these teams have been based in the United States and Western Europe, but with a globally recognized talent pool and the need to deliver more value within confined budgets, sponsors are now interested in offshore locations, such as India, South Africa, and Eastern Europe.

Here, I detail best practices for sponsors looking to incorporate offshore FSP teams.

Best practices for building offshore FSP teams

Best practices for building offshore teams from scratch include:

1. Developing a detailed recruitment plan

Creating a comprehensive recruitment plan that outlines timelines and mutually agreed-upon milestones is key to effectively launching offshore teams. The recruitment plan should be viewed as a living document that is reviewed regularly and updated as needed. The focus should be on “planned vs actual” metrics and ensuring that all roadblocks to recruitment are removed in a timely manner.Finally, this document must be based on hard data, acknowledging where the talent pool is and the track record in recruiting that population.

2. Focusing on early risk identification and mitigation

Obstacles to recruitment will occur, and anticipating and planning for these challenges early on will do much to support recruitment success. Common risks to recruitment include lengthy country-specific notice periods, changing economic conditions, and competition from other vendors and sponsors. The FSP vendor should have active plans to implement mitigation strategies to minimize any impacts due to these risks.

3. Identifying quality resources that fit the sponsor’s culture

Detailed and complete job descriptions are central to recruitment success, but beyond the pure technical skills, FSP recruitment must incorporate an assessment of overall “fit” within the sponsor’s organization. For example, does the role require working as part of a team or is an individual performer more likely to find success? All of this should be supported by a dedicated global talent acquisition team that understands where to find talent to increase the probability of recruitment success.

4. Accelerating onboarding

Strong onboarding is highly correlated to employee retention; it must be timely, practical, and clear. Ideally, new FSP hires should start one week prior to their first day with the sponsor, to allow time to complete internal training at the FSP provider, and to understand the sponsor’s expectations before starting from other team members or the FSP Lead. Finally, pairing up new hires with an already established “buddy” to which they can seek day to day advice on the role contributes greatly to new employee satisfaction.

5. Prioritizing retention

Tenets of effective retention planning start with a positive and seamless onboarding experience and progress to garnering employee feedback and establishing a continuous feedback loop. Other strategies include employee recognitions and rewards and offering creative professional development opportunities. Additionally, while salary and bonus are indeed important to employees, these should be supplemented with other important benefits, such as flexible work hours, to demonstrate employee value.

Considerations for sponsors

Many sponsors with already established onshore FSP teams are interested in offshoring options, essentially replacing these resources with resources in more cost-effective countries. In these cases, business continuity is the utmost priority and transition timings must work around the needs of the business and required portfolio deliverables. This requires a fair amount of upfront planning with the sponsor, based on the following questions:

Assuming that timeline slippage is not permissible and that all key deliverables are of equal priority, what are the key deliverables due this calendar year, mapped out by month?
Which FSP personnel to be transitioned are involved in these deliverables?
Within each FSP personnel assigned to a key deliverable, which are most critical (transitioned later), and which are less critical (transitioned earlier)?
For replacement headcount, what geographies are preferred (if any)?
What are the notice periods for these preferred geographies?
Finally, how do we reconcile the time required to transition off with the time required to transition on, while minimizing any work process disruptions?

This is an iterative process that requires close collaboration with the sponsor.

A Preview of Cytel’s Contributions at the 2025 CDISC + TMF EU Interchange

This week, on May 14–15, the CDISC + TMF EU Interchange 2025 will take place, just a few steps from our Cytel’s Geneva office.

This year at Cytel, we’re making the event even more special! We will be hosting a pre-conference, open to anyone able to arrive into Geneva before the event begins.

But that’s not all, together with my Cytel colleagues we will have three presentations and one poster, where my colleagues will share insights from their work with CDISC standards, including the Trial Master File Standards Model (CDISC-TMF). And it is from the contribution of my colleague Caroline Terril that I’d like to start with some anticipations of what the four Cytel presentations will be about.

Key Considerations for Biometrics CROs Not Managing the TMF — The Journey So Far

Caroline Terril, Thursday, May 15, 10:00–10:30 — Session 5E: TMF Management (TMF Track)

If you’ve ever asked yourself after these last three years what really matters when it comes to managing the TMF with CDISC — especially for biometric CROs that don’t directly manage TMFs — then my colleague Caroline Terril might have the answer. In her presentation, she will delve into our journey so far in trying to adopt the CDISC-TMF standard.

The Curious Case of External Controlled Arms (ECA): Practical Solutions for External and RWD Integration

Gautham Selvaraj (co-authored by me), Wednesday, May 14, 09:30–10:00 — Session 5C: Real World Data

At Cytel, we’ve seen increasing use of external control arms (ECA) in sponsor projects. In this presentation, Gautham Selvaraj will walk through two real-world case studies on integrating ECA data into CDISC-compliant datasets, exploring the unique challenges and solutions in aligning real-world data with CDISC standards.

Interested in learning more about ECA clinical trial design? Explore more of Cytel’s offerings and insights:

Governing the Ungovernable: Can a CRO Effectively Govern Its Standards?

Angelo Tinazzi, Thursday, May 15, 14:30–15:00 — Session 7C: Applied Standard Governance

Are you a CRO struggling with different Sponsor Interpretation of Data Standards? Or perhaps across multiple therapeutic areas or indications? Hard life, isn’t it?

Spoiler alert: although there’s no “magic” in my presentation, and no AI involved, I will offer practical insights into the complexities of CRO data standard governance. Sponsors are also welcome to join to see what life looks like from the other side of the barricades!

Managing SDTM Mapping Challenges in Multi-Study Portfolios: A Guide to Standards and Consistency

Jing Zhang and Marianne Dutfoy, Wednesday, May 14, 12:30–13:30 — Poster Session

In their poster, Jing Zhang and Marianne Dutfoy offer guidance for navigating SDTM mapping across multi‐study portfolios. They’ll address challenges such as inconsistent CRFs, variations in source data, and the hurdles of aligning historical studies with newer versions of standards.

Interested in learning more?

Download Angelo Tinazzi’s new ebook, “The Good Data Submission Doctor on Data Submission and Data Integration to the FDA”:

Enhancing the Reliability of Indirect Treatment Comparisons: The Role of Key Opinion Leaders

ITCs are essential for comparing two or more interventions when head-to-head randomized controlled trials (RCTs) are unavailable. In cases where patient-level data are available for at least one study, population-adjusted methods, such as matching-adjusted indirect comparison (MAIC) or simulated treatment comparison (STC), can be used to adjust for differences in treatment effect modifiers (TEMs) and prognostic variables (PVs) across study populations. Typically, relevant TEMs and PVs are identified through literature reviews, statistical approaches, and expert opinion.

To ensure the accurate identification and clinical relevance of TEMs and PVs, sponsors often consult with key opinion leaders (KOLs), improving the reliability of the ITC results. However, despite the critical and nuanced insight they can provide, the role of KOLs remains unstructured in formal guidance.

Here, we discuss the need for guidelines that outline when and how to integrate KOL input for better-informed healthcare decision-making.

The uncharted role of KOLs in ITCs

Health technology assessment (HTA), specifically in the context of ITCs, is an area driven largely by quantitative methods. Yet, the qualitative nuance provided by clinical experts, or KOLs, is indispensable. KOLs offer insights into TEMs and PVs that might otherwise elude purely data-driven models.

Current guidance documents

Limited structured guidance from HTA bodies and professional societies leads to inconsistent KOL engagement. Current guidance documents for conducting ITCs (e.g., the NICE methods manual1 and DSU TSD 182) emphasize identifying potential TEMs via expert discussion but leave practical KOL engagement strategies underdefined.

Guidance from non-payer organizations

The lack of guidance from non-payer organizations is also evident. The Cochrane Handbook3 discusses both methodological strengths and pitfalls of potential bias when treatments or populations vary in subtle but clinically important ways. However, the guidance is primarily focused on quantitative data synthesis rather than the integration of qualitative insights.

The PRISMA guidelines4 stress the need for transparent reporting when combining evidence across comparisons, but no tools or frameworks are proposed for capturing qualitative contributions.

A 2023 review5 of methodological approaches for identifying TEMs in ITCs highlighted that available guidance largely focused on statistical methods for adjusting TEMs rather than systematic and comprehensive processes for identifying TEMs. In addition, only 17 of 511 (3.3%) ITCs included in the review presented a description of the selection process for TEMs.

Bridging the gap: Methodological and procedural challenges

The current landscape is marked by a reliance on ad hoc approaches. KOL input on ITCs is often collected on an “as-needed” basis — sometimes late in the process — which may result in missed opportunities to refine study protocols early on. Without structured guidance from HTA bodies and professional societies, engagement with KOLs remains inconsistent. This gap underscores a broader tension: the need to honor the nuance of clinical insights while adhering to statistical rigor. It has been suggested that solicitation of KOL input should occur during the early, formative phases of the research process within a pre-specified framework.6 Late-stage involvement and integrating KOL input post-hoc — after the core design and analysis decisions have been made — can introduce bias and risks the integrity of the ITC.

Several methods for structured expert input, such as the Delphi technique or nominal group processes, have been proposed in adjacent fields, but these are rarely applied in the context of ITCs.7 The consequence is a reliance on unstructured interviews or informal consensus-building, which can introduce subjectivity and reduce reproducibility.

Looking forward: Harmonizing expert input with methodological standards

The way forward lies in bridging the divide between clinical intuition and methodological precision. The development of clear guidelines that outline when and how to integrate KOL input would be a significant step toward enhancing the reliability of ITCs. One promising approach is the early engagement of KOLs in, for example, structured Delphi panels or advisory boards during the protocol development stage. Codifying this process would ensure that expert insights inform the research from the outset, rather than serving as an afterthought.

HTA bodies, regulatory agencies, and academic methodologists should prioritize the collaborative creation of comprehensive guidelines to address the following key aspects of KOL consultation for ITCs:

Selecting KOLs: Defining objective, transparent eligibility criteria to ensure that only the most appropriate clinical experts contribute their insights.
Timing: Detailing when during the research process expert opinion should be solicited — ideally early on to influence study design and TEM identification.
Question types: Guiding the formulation of questions that address specific knowledge gaps related to TEMs and PVs in the ITC.
Integration protocols: Outlining systematic methods for incorporating and reporting KOL insights, ensuring this information is subject to the same transparency standards as quantitative data.

The accurate identification of TEMs can significantly influence the reliability of ITC outcomes. Without consistent frameworks, there’s a risk that KOL input is either underutilized or inconsistently applied, affecting both the credibility and applicability of findings. The lack of guidance highlights the need to explore effective approaches in the absence of standardized methodologies for KOL engagement. Addressing this gap is essential for improving the reliability of ITC results and supporting informed healthcare decision-making.

Upcoming webinar

Our Evidence, Value, and Access team will be hosting the upcoming webinar, “Navigating the First Year of EU JCA Implementation: Updates, Methodological Insights, and Bridging Local HTA Realities,” on July 10 at 10 am ET. Register today to reserve your spot!

From Toplines to Triumph: Visualizing the Pathways to Regulatory Approval

Achieving positive topline results in a clinical trial marks a critical milestone in the drug development process, yet it is far from the end of the submission journey. Instead, it signals the start of a complex, fast-paced effort to prepare for regulatory submission and navigate the FDA’s multi-stage review. The final “regulatory defense” stage demands rigorous collaboration, meticulous planning, and adaptability to meet the expectations of regulatory agencies.

Here we discuss the key stages in the post-topline journey, exploring key milestones, unexpected challenges, and best practices for ensuring a strong submission and a smooth path to approval.

1. The Preparation: Post-topline readiness and strategic planning

The preparation phase begins immediately after topline results are available. During this critical window — often lasting several months — cross-functional teams shift their focus to assembling the final submission package. Statisticians and programmers play a central role here, finalizing the tables, listings, and figures (TLFs) that will populate the Clinical Study Report (CSR) and preparing submission-ready datasets following CDISC standards, including ADaM, SDTM, and associated documentation.

In parallel, a pre-BLA or pre-NDA meeting with the FDA is typically scheduled to align on expectations, identify potential concerns, and set the foundation for a smoother review process. This phase is not just about document generation; it’s about establishing a strategy, anticipating regulatory scrutiny, and ensuring the submission is both complete and compelling. The quality of the groundwork laid here often dictates the ease — or difficulty — of the phases that follow.

2. The Submission: Crossing the threshold to regulatory review

Once the submission is filed, the process transitions into a more structured phase governed by the FDA’s review protocols. The agency begins with a 60-day filing review to assess whether the BLA or NDA is complete and acceptable for full review. If so, the sponsor receives a Day 74 Letter, which provides early feedback, flags any immediate concerns, and confirms the Prescription Drug User Fee Act (PDUFA) date — typically 10 months post-filing for standard reviews or 6 months for priority reviews. Although this phase may seem procedural, its significance is high. A clean, well-organized submission can streamline the review process, limit questions, and reduce the risk of delays. This is also the point where rolling submissions, if applicable under Fast Track designation, can offer a tactical advantage by accelerating document delivery and potentially shortening review timelines.

For statistical and programming teams, this is not a time to sit back and relax — it’s an opportunity to ensure internal alignment and anticipate questions the FDA may raise based on known data complexities. Strong documentation and traceability within datasets and outputs are essential at this point, helping to support any needed follow-up. Proactive communication and readiness during this phase help lay the groundwork for the more intensive regulatory engagement that follows.

3. The Regulatory Defense: Responding, clarifying, and defending your data

The regulatory defense phase is where the bulk of agency interaction occurs — and where flexibility and responsiveness become essential. During this time, the FDA may issue multiple information requests (IRs), asking for clarification on statistical methodology, specific data points, or safety and efficacy outcomes. Mid-cycle communications, typically occurring around months 4–5 for standard reviews, offer a formal opportunity to assess the review’s progress and surface any significant concerns.

In some cases, the agency may convene an Advisory Committee (AdCom) meeting to gather expert input, particularly when there are outstanding safety questions or complex benefit-risk considerations. Throughout this phase, the ability to quickly respond to ad hoc requests, provide high-quality data outputs, and maintain close collaboration across functions is critical. It’s a high-stakes stage where well-prepared teams can help preserve timelines and ensure the submission stays on track.

4. The Unexpected: Adapting to setbacks and charting a new course

In some cases, the regulatory journey doesn’t lead directly to approval. If the FDA identifies significant deficiencies in the initial submission — whether related to clinical data, statistical interpretation, manufacturing, or safety — it may issue a Complete Response Letter (CRL). This marks a temporary halt in the process, requiring the sponsor to address the concerns before resubmission. Depending on the scope of the deficiencies, the resubmission may fall under Class I (minor issues, reviewed in 2 months) or Class II (major issues, reviewed in 6 months).

For statisticians and programmers, this could mean conducting additional analyses, integrating new data, or adjusting the structure and presentation of the submission package. While a CRL can be a setback, it’s also an opportunity to recalibrate, seek additional guidance from the FDA, and improve the likelihood of approval in the next cycle. The key is to approach this phase with transparency, strategic thinking, and a readiness to adapt and respond.

Final takeaways

The path from topline results to regulatory approval is rarely linear. Timelines can range from as little as 12 months in expedited reviews to over 30 months in cases involving major deficiencies and resubmissions. Success in this post-unblinding phase hinges on proactive planning, adaptable resourcing, and the ability to respond quickly and thoroughly to regulatory needs. Equally important is collaboration across functions — clinical, regulatory, biostatistics, programming, and operations must work closely and cohesively to anticipate challenges, align timelines, and respond efficiently to agency requests. Whether following a standard or accelerated route, the shared priority is a comprehensive, high-quality submission that stands up to regulatory scrutiny — and ultimately supports timely access to new therapies for patients.

Interested in learning more?

Watch Jasperlynn Kao and Florence Le Maulf’s recent webinar, “From Toplines to Triumph: Visualizing the Pathways to Regulatory Approval”:

Career Perspectives: A Conversation with Angie Raad-Faherty

In this latest edition of our Career Perspectives series, we had the pleasure of speaking with Angie Raad-Faherty, Director, EVA Health Economics. Angie shares her journey from a background in applied mathematics and biology to a career in health economics. In this interview, she shares emerging trends in health economics and RWA, expertise that will be essential for the future of drug development, the importance of mentorship, and much more.

Can you give us a little background on your career so far? What inspired you to pursue an education in applied mathematics and biology, and how did that lead to a career in health economics?

My career journey has really been shaped by a deep passion for both mathematics and biology. Even back in high school, I loved the logic and problem-solving side of math, but I was equally fascinated by biology, especially in understanding how diseases affect the human body.

After completing my undergraduate degree, I took a graduate course that focused on disease mathematical modeling. This experience was pivotal, as it introduced me to the concept of integrating mathematical techniques with biological applications. I realized that my skills in mathematics could be effectively applied to address complex health-related issues, leading me to the field of health economics. I feel really fortunate that my background in applied mathematics and biology allows me to look at health problems from both a quantitative and biological lens.

In your current role, you balance leadership, coaching, and hands-on research. How do you manage this mix, and is it important for your job satisfaction to stay involved in both areas?

In my current role, I’ve found a rhythm that really works for me — balancing leadership, coaching, and hands-on research. Clear communication and thoughtful delegation are key, but I also make it a point to stay close to the actual work. I think it’s really important to empower my team to take ownership of their projects, while also being available to guide and support them when needed. What I’ve realized is that staying involved in the hands-on side of things isn’t just good for the work, it’s important for me personally. It keeps me engaged, helps me stay up to date with what’s happening in the field, and allows me to contribute in a meaningful way. Plus, it helps create a collaborative atmosphere where people feel supported and encouraged to try new things. That balance between leading and doing is what makes my role fulfilling. It not only makes me a more effective leader, but also helps us deliver stronger results as a team.

What do you like best about your role, and about working at Cytel?

What I love about my role is the opportunity to make a real difference in patients’ lives. By supporting my clients, I’m able to contribute to bringing innovative, cutting-edge treatments to patients in need.

I also enjoy the unique challenges that come with each project — no two are ever the same. Every new project is a chance to learn something new, whether it’s about a different disease area or an emerging therapy.

And finally, one of the things I truly value about working at Cytel is the people. I get to engage with a variety of clients and work on diverse projects and indications, but just as importantly, I’m surrounded by incredibly smart, driven, and supportive colleagues. It makes the work both meaningful and enjoyable.

In your opinion, which skills are critical to a function as a research consultant at Cytel?

I believe both hard and soft skills are critical for a research consultant in the HEOR field in general and at Cytel. On the hard skills side, strong technical skills in HEOR methods, evidence synthesis, and understanding HTA requirements is essential — especially since expectations and requirements differ between HTA bodies.

Soft skills are just as important, like critical thinking, flexibility, and clear communication. In my experience working on HTA submissions for both countries, I learned it’s not just about building strong models but also explaining the results clearly to different audiences and adapting based on local needs.

Success really depends on balancing technical excellence with the ability to collaborate and adjust strategies based on specific client and agency expectations.

Given how quickly the field of health economics evolves, continuous learning is crucial. Are there any skills or areas of expertise you’re currently focusing on that you believe will be key to the future of drug development in 2025 and beyond?

Absolutely, continuous learning is not just beneficial, it’s essential in our field to stay ahead of the curve in areas that will define the next decade of drug development and market access. While technical skill development is ongoing, my focus is also on strategic foresight. Right now, I’m particularly focused on three key areas:

First, the integration of real-world evidence into economic models. We’re seeing increasing acceptance from HTA bodies to go beyond clinical trial data. As such, building rigorous frameworks for incorporating real-world data, while maintaining methodological transparency is a top priority.
Second, understanding how machine learning and artificial intelligence can be leveraged in health economics. There’s huge potential here, but it’s critical we align these innovations with HTA standards and ensure that models remain transparent, logically sound, and valid for reimbursement decisions.
Finally, I’m very focused on global HTA alignment. As frameworks become more interconnected, strategically aligning value messages and evidence packages across jurisdictions will be key to driving efficiency and access.

Are there any emerging trends in health economics and RWA that excite you right now?

Absolutely, there are several exciting developments in health economics that I find particularly inspiring.

One major trend is the increasing use of real-world data earlier in the drug development process to inform trial design, support regulatory decision-making, and identify unmet needs or specific patient populations.

I’m also really encouraged by the growing emphasis on patient-centered outcomes and health equity. There’s a broader recognition that value goes beyond traditional metrics like QALYs or ICERs. Incorporating factors like caregiver burden, and access disparities is making economic evaluations more holistic and aligned with real-world impact. Another area that particularly interests me is the use of surrogate outcomes. Being able to translate clinical endpoints into meaningful modeling endpoints is crucial, especially when long-term outcomes are difficult to measure directly.

Lastly, the advancement of AI and machine learning is a trend I’m closely following. These technologies are opening doors to deeper insights and faster analyses of complex, unstructured data. While we still need to ensure transparency and methodological rigor, the potential to uncover patterns and generate predictive insights is incredibly exciting. Overall, it’s a dynamic time in our field, and these trends are not only transforming how we work but also reinforcing the importance of continuous learning and adaptability.

Could you share a project you’ve worked on that you’re particularly proud of, and why?

Every project I’ve worked on in health economics has felt important to me, because each one represents a chance to help patients access innovative therapies. But the project that stands out most is actually the very first HTA submission I worked on early in my career. It was for early prostate cancer therapy. We were able to build a strong case for both the clinical value and the cost-effectiveness of the therapy, and seeing it approved and knowing it would change lives was incredibly powerful. That experience stayed with me and really shaped my passion for HEOR, showing me how our work can directly contribute to patient access and better outcomes.

As someone completing a PhD in applied mathematics and with a leadership role in RWA — both areas where women are underrepresented — what advice would you give to young women or girls aspiring to enter STEM fields?

STEM is full of tough questions and complex challenges — but that’s exactly what makes it so rewarding and interesting. Diverse thinking drives better science, more inclusive solutions, and ultimately, stronger outcomes in healthcare. And that’s exactly what our field needs. Also, mentorship and community are important. Throughout my journey, having people around me who believed in my potential, even when I didn’t yet see it myself, made a huge difference. That kind of support helps build the confidence not just to grow, but to lead. STEM needs more women not just participating, but shaping its future, and I encourage every young woman to see herself as part of that transformation.

Have you had a female mentor during your education or career? How did that impact you? Would you be open to mentoring women yourself in the future?

Yes, I had the privilege of working with my supervisor, Dr. Jane Heffernan, during my graduate studies. Her guidance and support were instrumental in shaping my academic and professional development. She provided valuable insights and encouragement, which significantly impacted my confidence and skills in my field.

In the future, I would be open to mentoring women myself, as I believe in the importance of supporting the next generation of professionals and fostering an inclusive environment in academia and beyond.

As a remote employee, how do you maintain a healthy work-life balance? What strategies work for you, and do you feel supported by Cytel in this regard?

To maintain a healthy work-life balance while working from home, I believe two key factors are essential. First, establishing a consistent routine with clearly defined working hours and scheduled short breaks throughout the day is crucial. This structure helps me stay productive while also allowing time to recharge. Second, creating a designated workspace that is separate from my everyday home activities is vital. This physical distinction not only enhances my focus but also aids in mentally transitioning between my professional and personal life. I appreciate that Cytel supports this balance through its flexible working hours, which further enables me to manage my responsibilities effectively.

What are your main interests outside of work?

Outside of work, I really enjoy getting outside for walks and hikes with my dogs — it’s one of my favorite ways to unwind. I also love spending time in the kitchen, whether I’m baking something sweet or trying out a new dish from a different cuisine. It’s my way of relaxing and getting a little creative.

Finally, what’s one piece of career advice you wish you had received earlier?

A key piece of career advice that holds significant value is to prioritize networking and relationship-building within your industry. This includes not only connecting with colleagues beyond your immediate team but also engaging with clients. Cultivating a robust professional network can unlock new opportunities, provide essential support, and offer valuable insights that can greatly influence your career path. Additionally, actively engaging with mentors and peers fosters continuous learning and personal growth, making networking an essential component of career development that is often underestimated.

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Interested in learning more?

Can you give us a little background on your career so far? What inspired you to pursue a master’s degree in medical sciences, and how did that lead to your first jobs as a Clinical Research Associate?

Alongside your role as a Clinical Research Associate, you also worked as a Science Journalist for Swedish TV for a year. How did that opportunity come about, and what was that experience like? How did it complement or contrast with your work in clinical research?

You started at SDS Life Science in 2021 and became part of Cytel, following its acquisition. How was that transition for you, and what were the biggest adjustments to working within a larger organization?

You are now a Principal Consultant Clinical Project Management at Cytel. What does your function entail? Could you walk us through a typical workday?

What do you enjoy most about your role, and about working at Cytel?

Your job not only requires a keen understanding of clinical trials, but also collaboration and communication. Are there any other skills you believe are required to succeed in this role?

Your role involves working from our office, our client’s office, and remotely. How do you maintain work-life balance while switching between these environments? Do you still feel you have flexibility in your schedule?

Finally, when you’re not diving into work, what hobbies or passions keep you busy?

Types of MHRA inspections

Essential steps and documents

Strategies to streamline the inspection process

Apply the framework for engagement

Prepare supportive documents

Ensure staff is adequately trained

Use live demos or “show and tell” sessions

Final takeaways

Want to learn more?

Michaela, what inspired the creation of Cytel’s new workstreams that focus on specific therapeutic areas and methodologies?

Could you walk us through the focus of these new workstreams, and share some of the key activities involved?

How do these workstreams integrate with the existing clinical biometrics services we offer?

How do our clients benefit from these workstreams?

Now, you moderate the neurology workstream. Can you share some of your activities?

Could you be more specific and share examples?

Can you share an example of a client engagement where your workstream made an impact?

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What is assurance?

What is the performance score?

What is the robustness score?

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1. Developing a detailed recruitment plan

2. Focusing on early risk identification and mitigation

3. Identifying quality resources that fit the sponsor’s culture

4. Accelerating onboarding

5. Prioritizing retention