Better Use Of Phase II Trials Urged By FDA Statistician O'Neill
Executive Summary
FDA is reiterating the value of conducting a robust Phase II program as part of its discussions of adaptive trial designs, as the agency tries to urge sponsors to conduct sufficient exploratory trials to support successful Phase III trials
You may also be interested in...
Adaptive Trials Could Have A Steep Regulatory Learning Curve
Sponsors should take care that drug development efficiencies gained with the advent of adaptive clinical trials aren't offset by lack of opportunity to reflect on data from one trial to the next and "design a thoughtful, complete program," FDA warns in its draft guidance for adaptive trial design
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials