Written by Alind Gupta, Cytel; Haridarshan Patel, Horizon Therapeutics; and Jason Simeone, Cytel
Ophthalmology is well-suited to using artificial intelligence (AI) methods because clinical decisions often rely on complex data-rich information from medical images of the eye and patient health status. AI has revolutionized image data analysis over the last decade and is promising to improve healthcare delivery and clinical decision-making while reducing healthcare costs. In fact, some AI-based diagnostic platforms for early detection of diabetic retinopathy have received FDA clearance and have been introduced in resource-constrained healthcare settings worldwide to screen for early signs of disease and to accelerate patient access to correct therapies. Read more »
The past two decades have seen the adoption of great innovation in clinical trial design. Statisticians have risen to the challenge by proposing a myriad of solutions to the ever more complex questions being posed by the trial team. Bayesian statistical techniques have been key among the various methodologies proposed in solving difficult problems, but only recently have they come into their own as computation and simulation power have matured.
One of the chief concepts at the heart of Bayesian inference is Read more »
For this edition of the Industry Voices series, Maria Lundberg, Managing Director of SDS Life Science, a Cytel company, discusses a holistic approach to therapeutics development and how this recently expanded team supports clients across the globe.
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In the ever-evolving landscape of clinical development, the need for robust evaluation of interim clinical data through Independent Data Monitoring Committees (IDMC) has become increasingly vital. IDMCs play a pivotal role in ensuring patient safety and upholding trial integrity amid the growing complexity of clinical development programs. Independent data monitoring is especially critical in Central Nervous System (CNS) studies due to the challenges noted with proper enrollment of patients, rater variability, and placebo response rates, among others.
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In the ever-changing field of clinical trial design, there is often a need to evaluate design options quickly and efficiently. But when it comes to evaluating options, which is better: commercial or open-source software? And does it need to be a question of either-or? Read more »
As of March 2023, specifically for any study started on or after March 15, 2023,1 for the submission of SEND, SDTM, and ADaM packages, the FDA recommends the use of Define-XML 2.1 (while this is not yet the case for PMDA).2, 3, 4 However, since Data Requirement Ends for Define v2.0 are not available, submitting data using Define v2.0 is still acceptable.
The landing page of the CDISC Define-XML 2.1 anticipates six major updates:
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Cytel’s Functional Service Provider (FSP) teams work on exciting projects with biotech and pharmaceutical companies as statistical programmers and biostatisticians. We spoke with Jeff Thompson, R Senior Statistical Programmer, who is based in the US and working with a leading global biotech company, about the projects he found most fascinating and what it’s like to work as a statistical programmer with Cytel’s FSP. Read more »
Cytel’s Functional Service Provider (FSP) teams work on exciting projects with biotech and pharmaceutical companies as statistical programmers and biostatisticians. We spoke with Nandan Kothavale, Programming Senior Team Lead, who is based in India and works with a global pharmaceutical company, about the projects she found most impactful and what it’s like to work as a statistical programmer with Cytel’s FSP. Read more »
Moving beyond static evidence development to ensure local market access success; responding to recent changes in governmental drug regulations and the role of automation
The worldwide drug regulation landscape is rapidly changing. The introduction of the EU Health Technology Assessment (HTA) Regulation (EU) 2021/2282 and US Inflation Reduction Act (IRA) created a need for pharmaceutical companies to develop strategies to generate data through diverse patient data sources and use complex methodologies while keeping pace with evolving evidentiary requirements for their products across healthcare decision-making bodies. Read more »
Interpreting all guidelines before your first-in-human clinical trials can be overwhelming. While guidelines are helpful, they should not be read like instruction manuals that can be applied the same way to every project. It is even possible that certain guidelines do not apply to your project at all! Therefore, guidelines need to be customized to fit your unique project. Before diving headfirst into the guidelines, read on for tips to help you understand the essential regulatory requirements leading up to first-in-human clinical trials. Read more »
