
Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.

May 24, 2023
As of March 2023, specifically for any study started on or after March 15, 2023,1 the submission of SEND, SDTM, and..
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May 22, 2023
New CADTH Guidance on RWE Is Now Available, but Critical Aspects Are Still Missing
By Grammati Sarri, Evie Merinopoulou, Vinusha Kalatharan, and Jason Simeone The Canadian Agency for Drugs and..
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May 10, 2023
FDA Increases Calls for Manufacturers to Ensure Trial Diversity, but Does It Fall Short of Addressing Health Inequalities in Product Development?
The evidence is staggering on the unequal health burdens experienced by specific patient groups defined by ethnic,..
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May 5, 2023
Scott Gaines on the Power of Simulation-Guided Design to Handle Increasingly Complex Clinical Trials
As clinical trials become more complex, simulation-guided design approaches are crucial. For this edition of the..
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May 3, 2023
Reflections on the RCT DUPLICATE Study and Increasing Confidence in Real-World Evidence
With input by Alind Gupta, Louis Dron, and Jason Simeone. Randomized clinical trials (RCTs) have long been considered..
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April 26, 2023
New Ebook: “The Good Data Doctor on Data Submission and Data Integration”
Regular technical discussions with the FDA play a critical role in ensuring data submission success. These discussions..
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April 25, 2023
How Target Trial Emulation Can Take the Guesswork Out of Comparative Effect Estimates in Medicare Drug Price Negotiation
An interview with Miguel Hernán, Harvard University Kolokotrones Professor of Biostatistics and Epidemiology On March..
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April 24, 2023
APAC Biopharma Industry Insights: Trends, Opportunities, and Challenges
In the last 10 years, the Asia-Pacific (APAC) region has become a hotspot for clinical trials: the region contributed..
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