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Adaptive Trial Paper Explores Benefits of Adaptive Trials for Phase I, Phase II Studies
Date:2/2/2010

momentum in early stage studies. "First, adaptive trials are most helpful when you do not know enough at the beginning of a trial to design it with confidence," he says. "This is much more likely to be true in phases I and II than in phase III.

"Second, the best way to make expensive phase III trials more successful is to do more thorough work in phases I and II," he continues. "Getting the dose right through well-designed phase I and phase II trials is the best way to maximize success in phase III, which then leads to a higher rate of NDAs.

Dr. Nayak offers insight and expertise on a variety of issues surrounding adaptive trial design, including:

 
  • Commercial, ethical, and budgetary benefits of the adaptive trial model;
  • Statistical and data issues;
  • Changing to the adaptive model across multiple sites;
  • Safety issues to consider;
  • Budgeting for an adaptive trial;
  • Dealing with independent decision-making bodies;
  • Patient consent and communication issues;
  • Medical supply logistics;
  • Other best practices and planning issues.

The abstract is free and available for download at Medelis.com.

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This abstract is the sixth in Medelis' complimentary "Peer Perspectives in Oncology" Q&A series, which brings together respected researchers to discuss issues that face Chief Medical Officers today: rising costs, optimum pati
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