White papers

White papers

 

Accelerated approvals (AA): not so fast!

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Everardo D. Saad, MD, Medical Director and Consultant, IDDI Marc Buyse, ScD, Chief Scientific Officer and Consultant, IDDI The development…

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eBook: The Ultimate Guide to Clinical Data Management

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Ensuring clinical data is ready for regulatory submission This eBook is a must-read that will enable clinical professionals to better…

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Why do so Many Phase III Fail?

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Randomized controlled trials (RCTs), particularly in phase 3, are the preferred sources of evidence for drug approval and reimbursement decisions….

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THE IMPACT OF COVID-19 ON RANDOMIZED CLINICAL TRIALS

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The COVID-19 pandemic has a major impact on the conduct of most on-going clinical trials, in particular on the treatment…

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IDDI Comments on FDA Draft Guidance on Expansion Cohorts

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The need to consider randomization whenever feasible in expansion cohorts The purpose of IDDI comments on FDA Draft guidance is to…

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