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Adaptive Trials Going Mainstream With Industry White Paper, FDA Guidance

Executive Summary

Adaptive clinical trials in drug development are moving towards broader acceptance and feasibility with the upcoming publication of an industry white paper and an FDA workshop on the subject

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Time To Be Creative With Adaptive Trials May Be Non-Pivotal Portion

BARCELONA, SPAIN - For companies looking to adopt adaptive trial designs, Merck VP of Biostatistics and Research Decision Sciences Jerald Schindler urged sponsors to frontload most of the adaptation in the non-pivotal portion of the clinical trial program and limit their own involvement in the adaptation that does take place during the pivotal portion

Time To Be Creative With Adaptive Trials May Be Non-Pivotal Portion

BARCELONA, SPAIN - For companies looking to adopt adaptive trial designs, Merck VP of Biostatistics and Research Decision Sciences Jerald Schindler urged sponsors to frontload most of the adaptation in the non-pivotal portion of the clinical trial program and limit their own involvement in the adaptation that does take place during the pivotal portion

Late-Stage Trials Pose Challenge As FDA Molds Adaptive Design Guidance

The work group developing FDA's guidance on adaptive clinical trial design is still trying to figure out the complex issues associated with late-stage studies, the Center for Drug Evaluation and Research's "town hall" discussion at the Drug Information Association annual meeting in Atlanta revealed

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