Perspectives
Unlock new insights with Cytel’s Perspectives blog. Our experts share their views on the latest industry trends, with cutting-edge thought leadership and expert analyses spanning the spectrum of drug development and clinical trials.
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Abbey Poirier
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Michelle Hoiseth
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Nathalie Horowicz-Mehler
Naydene Slabbert
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Nicolas Rouillé
Nitin Patel
Ophélie Calas-Zeroug
Pantelis Vlachos
Patti Arsenault
Peggy Schrammel
Peter Wigfield
Philipp Bauknecht
Ralf Koelbach
Reza Jafar
Robert Szulkin
Romain Moreau
Russanthy Velummailum
Sadiqa Mahmood
Scott Rogers
Sebastià Barceló
Shanna Cotti
Sheree King
Sofie Vandevyver
Sophie van Beekhuizen
Stacy Grieve
Stefan Baumanns
Stéphanie Dontenville
Stephanie Rondeau
Stève Bénard
Steven Thacker
Strategic Consulting
Subhajit Sengupta
Susannah Sadler
Valeria Mazzanti
Veena Palle
Vicki Young
Victor Laliman-Khara
Walter Boyle
Walter Briggs
William Baker
Wyatt Gotbetter
December 16, 2025
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December 11, 2025
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The Medical AI Superintelligence Test and NOHARM: A New Framework for Assessing Clinical Safety in AI Systems
December 9, 2025
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FDA Guidance on Assessing Overall Survival in Oncology Trials: A DMC Perspective
December 4, 2025
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Evaluating Safety and Efficacy in Phase III Alzheimer’s Disease Trial: Endpoints and Statistical Analysis Methods
December 2, 2025
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Empowering Patient Engagement in HTA: Lessons from an AI-Generated Plain Language Summary Case Study
November 25, 2025
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Regulatory Guidance on Patient-Centric DMC Risk-Benefit Assessments
November 18, 2025
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The FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies
November 13, 2025
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The Last “C” in CMC: Why Controls Are the Safeguard of Drug Development
November 6, 2025
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Statistical Insight for Strategic Impact: How Statisticians Help Medical Affairs Make the Most of Their Data
November 4, 2025
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Micro-Decisions, Macro Impact: Cultivating an Agile Mindset in Every Line of Statistical Code
October 29, 2025
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Women’s Health Is Society’s Wealth: Unlocking Economic Value When Bridging the Gender Health Gap
October 21, 2025
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Generative AI in Evidence Synthesis: Harnessing Potential with Responsibility
October 14, 2025
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Breaking Barriers in Rare Disease Research with Generative AI and Synthetic Data
October 9, 2025
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Analyzing Endpoints in Multiple Sclerosis Clinical Trials: Statistical Considerations
October 7, 2025
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From Metadata to Submission: Rule-Based Robotic Process Automation for Statistical Programming Excellence
October 2, 2025
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External Control Arms: A Powerful Tool for Oncology and Rare Disease Research
September 30, 2025
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Agentic Autonomy: How Multi-Agent Systems Could Orchestrate the Future of Clinical Development
September 25, 2025
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Addressing Evidentiary Gaps with Advanced Quantitative Methods
September 4, 2025
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The Estimand Framework in Oncology Trials
August 28, 2025
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Redefining Clinical Documentation in the Age of Intelligent Collaboration: The Rise of the AI-Assisted Medical Writing Strategist
August 26, 2025
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Blinded Independent Central Review in Oncology Trials: Key Challenges
August 19, 2025
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Breathing Easier: How Wearables Are Revolutionizing Patient-Reported Outcomes in Respiratory Disease
August 14, 2025
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Streamlining Data Management and Improving Statistical Accuracy in Clinical Trials with AI
August 12, 2025
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Improving Efficiency in Oncology Dose-Escalation Trials: A Cautious Bayesian Approach
August 7, 2025
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Trustworthy AI in Action: Predicting Stroke Risk Transparently with Claims-Based Machine Learning
August 5, 2025
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FDA OCE Project Frontrunner: Accelerating First-Line Oncology Drug Development
July 29, 2025
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Blending Power and Flexibility: How AI-Generated R Code is Reshaping Clinical Trial Design
July 22, 2025
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Leveraging Mobile and Wearable Technology for Outcomes Research in Depression
July 16, 2025
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Interim Decision-Making in Clinical Trials: A Focus on Sample Size Re-Estimation and Population Enrichment
July 8, 2025
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Smartwatches Are Transforming Clinical Trials: Insights from Digital Primary Endpoints
July 1, 2025
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How CDISC and CDASH (CRF Standards) Streamline Clinical Trials
May 29, 2025
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Strategies to Streamline the MHRA Inspection Process
May 22, 2025
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Advancing Clinical Trials Through Shared Expertise and Collaboration
May 13, 2025
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A Preview of Cytel’s Contributions at the 2025 CDISC + TMF EU Interchange
May 8, 2025
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Enhancing the Reliability of Indirect Treatment Comparisons: The Role of Key Opinion Leaders
May 6, 2025
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From Toplines to Triumph: Visualizing the Pathways to Regulatory Approval
May 1, 2025
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Patient Centricity in Comparative Effectiveness Research
April 22, 2025
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Advancing Equity in Health Technology Assessment: Lessons from CAR T-Cell Therapies
April 17, 2025
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Data Submission to Health Authorities: Current Practices and Future Directions
April 1, 2025
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Expediting the Regulatory Submission Process with Automated Tools
March 27, 2025
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Winning in a Budget-Constrained World: Smarter Clinical Trial Optimization
March 24, 2025
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Adaptive Pivotal Clinical Trials with Composite Hierarchical Outcomes
February 27, 2025
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Harnessing AI-Powered Tools for Clinical Trial Design Coding
February 25, 2025
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The Year Ahead for FSP: Open Source, AI, Global Reach, and Cost Efficiency
February 18, 2025
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PBPK Modeling and Simulation: A Transformative Tool for Early-Stage Clinical Development
January 28, 2025
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Getting Your Data Strategy Right: Seven Tips for Balancing Science, Efficiency, and Patient Centricity
January 23, 2025
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Driving Innovation in Clinical Trial Design: Open Source, Commercial Software, and AI in 2025
January 21, 2025
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Launch Communication: Addressing HCPs Effectively and Ensuring Product Success
January 9, 2025
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Advancing Clinical Data Standards: Guidance, Regulations, and Key Standards Developments
December 10, 2024
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Ten Key Qualifications for Independent Statisticians Reporting to the DMC
December 3, 2024
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Oncology Drug Development Under Project Optimus: Case Studies
November 26, 2024
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Vaccine Efficacy Trials: Design Considerations and Simulation Tools
November 19, 2024
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Oligonucleotide Therapeutics: An Emerging Modality Bringing Great Hope in Medicine
November 5, 2024
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Guide to Successful G-BA Consultations: Practical Tips for Market Access Professionals
October 17, 2024
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FDA Guidance on Integrating RCTs into Clinical Practice and the Growing Potential of RWE
October 10, 2024
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Unlocking Germany’s Pharmaceutical Market: A Guide to AMNOG and Market Access
September 26, 2024
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Automating Log Checks: A Case for Innovation in Statistical Programming
September 24, 2024
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Understanding Clinical Pharmacology: From Strategic Studies to Product Labeling
September 5, 2024
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Navigating Dose Optimization in Drug Development: Answering Questions about Project Optimus
September 2, 2024
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Simulating Survival Outcomes for Unanchored Simulated Treatment Comparisons: Guidance on Censoring Approaches
August 20, 2024
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Oncology Clinical Trials: Design Trends in Biomarker Research
August 13, 2024
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External Validity Bias in HTA Submissions: A Case for Transportability Methods
August 1, 2024
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The Role of External Data in Oncology Drug Development
July 18, 2024
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Patient Journey-Centric Study Designs in Clinical Trials
July 2, 2024
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FDA’s Project Optimus: Redefining Oncology Drug Dosage for Better Patient Outcomes
June 18, 2024
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Planning Strategies for Externally Controlled Trials: Insights from ISPOR US 2024
June 13, 2024
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Behind the Oncology Research: An Interview Between Robert Szulkin and Jana de Boniface
June 11, 2024
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Subpopulations in Clinical Trial Design: Thinking Through Hypothesis Testing
May 28, 2024
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Differentiating Your Inflammatory Disease Product: Common Challenges
May 23, 2024
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Why Simulate Study Design at a Large Scale? Leveraging Cloud Computing for Confident Results
May 14, 2024
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The Role of Key Opinion Leaders in Rare Disease Clinical Trials
April 22, 2024
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Defining Probability of Success in Clinical Trial Design with Commercial Software and R Coding
April 17, 2024
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Early Planning Strategies for External Control Arms in HTA and Regulatory Submissions
April 5, 2024
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Commercial and Open-Source Software Synergy for Clinical Trial Design
March 20, 2024
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Key Elements and Implications of the Draft EU JCA Implementing Act
February 26, 2024
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Sample Size Re-Estimation for Rare Disease Clinical Trials
February 23, 2024
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Metadata Repositories: Overcoming Challenges with Automation
February 13, 2024
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Strategies to Overcome Limited Patient Population Challenges in Rare Disease Studies
January 22, 2024
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How to Save Time and Limit Costs toward First-in-Human Clinical Trials
January 17, 2024
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Late-Stage Clinical Development Strategy: Trade-Offs and Decision-Making in the Confirmatory Setting
December 6, 2023
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Drug Manufacturer Auditing: Ensuring Quality, Control, and Safety
December 4, 2023
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Preserving Trial Integrity After Receiving an Unanticipated IDMC Recommendation
November 29, 2023
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Don’t Forget the Development of Your Placebo: Overcoming Common Obstacles
November 20, 2023
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Guidelines Are Not Instruction Manuals: Customize Your Way to First-in-Human Clinical Trials
November 17, 2023
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FSP Behind the Scenes with Nandan Kothavale, Programming Senior Team Lead
November 13, 2023
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First-in-Human Drug Substance and Formulation: The Challenge of Achieving Flexibility and Quality
November 3, 2023
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Reinforcement Learning: A Promising Tool for Predicting Optimal Treatment in Complex Diseases
November 1, 2023
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The Changing Landscape of the Pharmaceutical Industry: A Preview of Cytel’s Contributions at PHUSE EU 2023
October 27, 2023
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News from ESMO: Challenging the Status Quo of Early Phase Clinical Trial Design — Moving from “Why” to “How”
October 25, 2023
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Unravelling PICO: The Pillars of the European Joint Clinical Assessment
October 20, 2023
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Mind the Health Gap: Is It Time to Reliably Measure the Impact of Health Inequity in Product Development and Assessment? Yes, It Is.
October 18, 2023
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Preparing Your Integrated Summaries of Safety and Effectiveness: Best Practices
October 13, 2023
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Looking to the Future — Improving Diagnosis and Prognosis of Eye Conditions with Artificial Intelligence
October 4, 2023
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How to Ensure Your Adaptive Trial Is Appropriate for Regulatory Submission
September 29, 2023
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Innovative Clinical Trial Design: Commercial vs Open-Source Software? Why Not Both?
September 25, 2023
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Reducing Independent Data Monitoring Committee Timelines: A Focus on Formal Interim Analyses
September 20, 2023
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FSP Behind the Scenes with Anwaya Joshi, Programming Senior Team Lead
September 13, 2023
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Setting Expectations for Formal Interim Analyses with Independent Data Monitoring Committees
August 30, 2023
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FSP Behind the Scenes with Jeff Thompson, R Senior Statistical Programmer
August 22, 2023
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Adaptive Multi-Arm Multi-Stage Designs: A Comparison of Methods
August 14, 2023
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The Evolution of Open-Source Initiatives and New Standards Development for the Data Submission of the Future
August 9, 2023
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Standards and Open Source Hand-in-Hand: Leveraging Automation to Expedite Drug Market Request Review Process
July 14, 2023
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Real-Life Data-Sharing and EU Joint Clinical Assessments: Is Closing this Chasm a Mission Impossible?
June 20, 2023
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New FDA Guidelines on Pediatric Studies and Potential Effects on Opportunities for Market Exclusivity
June 14, 2023
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Embracing Innovation: Exploring the Design of Umbrella and Basket Trials
June 9, 2023
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Maximizing Study Momentum: A Case Study in Accelerated DMC Safety Report Creation through IDMC Solutions
June 2, 2023
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Presenting Clinical Data for Regulatory Submission: A Stats Perspective
May 22, 2023
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New CADTH Guidance on RWE Is Now Available, but Critical Aspects Are Still Missing
May 10, 2023
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FDA Increases Calls for Manufacturers to Ensure Trial Diversity, but Does It Fall Short of Addressing Health Inequalities in Product Development?
April 25, 2023
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How Target Trial Emulation Can Take the Guesswork Out of Comparative Effect Estimates in Medicare Drug Price Negotiation
April 14, 2023
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Data Challenges (and Solutions) for Externally Controlled Trials
April 11, 2023
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Overcoming the Shared Effect Modifier Assumption with Network Meta-Interpolation
April 5, 2023
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Comparative Effectiveness: Methods and Techniques for Better Decision-Making
March 13, 2023
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Industry Voices: Yannis Jemiai on Simulation-Guided Design and the Changing Landscape of Clinical Trial Strategy
January 31, 2023
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Linked Data Studies: Improving the Way We Do Observational Research in Germany
December 9, 2022
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(Re)Integration Dilemma: Integrated Summaries of Safety and Effectiveness
November 14, 2022
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Network Meta-Interpolation: Effect Modification Adjustment in Network Meta-Analysis Using Subgroup Analyses
September 16, 2022
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Raising Awareness for Additional FDA Data Standards Submission Recommendations (Part II)
September 15, 2022
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U.S. Drug Pricing Reform: Potential Impact on Pharma HEOR Evidence Generation
September 8, 2022
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Cytel Present at the ASA Biopharmaceutical Section Regulatory Workshop
June 15, 2022
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Raising the Awareness for Additional FDA Data Submission Recommendations (Part I)
May 24, 2022
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Leveraging Advanced Statistical Software to Optimize Clinical Development
April 21, 2022
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Bayesian Statistics and Its Applications: New Webinar by Professor Yuan Ji
April 12, 2022
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Career Perspectives: Interview with Charles Warne, Associate Director of Biostatistics
April 7, 2022
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Bridging the gap between oncology clinical trials and real-world data: evidence on replicability of efficacy results using German claims data
January 26, 2022
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Career Perspectives: Interview with Jessica Bhoyroo, Clinical Data Manager
February 18, 2021
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Introduction to Evidence Synthesis and Bayesian dynamic borrowing