Perspectives on Enquiry & Evidence

Cytel's blog featuring the latest industry insights.

Reflections on the RCT DUPLICATE Study and Increasing Confidence in Real-World Evidence

Randomized clinical trials (RCTs) have long been considered the gold standard for assessing the efficacy of medical treatments, but real-world evidence (RWE) is often more representative of routine clinical care. The RCT DUPLICATE study makes great strides in comparing the two, but the study has its limitations: notably, the lack of quantitative bias analysis.

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May 24, 2023

It’s Time to Move, Time to Move to Define-XML 2.1

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 16, 2023

Career Perspectives: A Conversation with KumKuen Yuen

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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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