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Adaptive Design Focus of Chapter Spring Meeting

1 August 2010 No Comment

The Princeton Trenton Chapter held its annual spring meeting on June 11. Because of the increasing use of adaptive designs in the pharmaceutical industry and the recent publication of the Food and Drug Administration’s draft guidance on adaptive designs, adaptive design seemed to be a good choice for a topic, especially in a region where most statisticians work in pharmaceuticals and clinical research.

Four local experts gave talks:

  • Naum Khutoryansky spoke about an adaptive design that was implemented in a phase II trial to explore the choice of dose for their factorVII drug to reverse the effects of warfarin.
  • Weli He, from Merck, discussed the critical considerations regarding the logistics and reduction of drug waste in adaptive designs. He showed how simulations could be used to identify problems and find solutions.
  • Jose Pinheiro, a member of the PhRMA working group on adaptive designs who works for Johnson & Johnson, presented an overview of the FDA draft guidance and discussed both what the industry likes about it and disagrees with.
  • Keaven Anderson, from Merck, spoke about adaptive trials with binary outcomes, where adaptations are based on blinded data that indicate the total number of events without separating them by treatment group.

The presenters’ slides are available here. With more than 85 registrants, this spring meeting saw the largest turnout in years.

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