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The FDA is promoting adaptive clinical trials, with plans to issue five new guidances. The agency said it is also setting up special teams to provide designers of adaptive clinical trials with consulting advice.
Adaptive clinical trials make it possible for sponsors to enroll smaller numbers of patients and put a quick stop to treatment approaches that aren’t working, while saving time and money, say experts. There is a strong business case for adaptive trials. They are said to be faster and more efficient, with midcourse correction for trials that are off target and fewer patients enrolled in ineffective treatment arms. Moreover, the FDA is actively encouraging sponsors to use this method, saying the adaptive approach is particularly relevant in clinical trials of new treatments for HIV/AIDS and cancer. The agency is promoting adaptive clinical trials with plans to issue five new guidances. One will aid trial sponsors in looking at multiple endpoints in a single trial. Another will present “enrichment designs” for clinical trials that can involve fewer subjects than traditional studies. The third deals with missing data in clinical trials and is being developed in cooperation with the National Academy of Sciences. The other two deal with data safety in adaptive trial designs and noninferiority trial designs. Despite their virtues, adaptive trials are still not well defined. This issue of The Food and Drug Letter explores how different experts define these trials, as well as the various advantages to using them.
A forceful “culture of approval” and attempts to muffle scientific dissent among agency reviewers have created significant problems in the FDA’s drug review process, witnesses at a House subcommittee hearing testified.
The FDA has followed a joint advisory committee’s recommendations in removing two of three approved indications for Ketek and adding a black box warning to the antibiotic’s labeling.
The Biotechnology Industry Organization (BIO) is praising President Bush’s proposed fiscal 2008 budget, but requested that Congress increase funding for the FDA.
The FDA denied Public Citizen’s request to remove Roche’s prescription weight loss drug Xenical from the market over concerns it could contribute to colon cancer.
The FDA warned DreamWest Innovations for failing to establish adequate design and testing files for its rapid intubation kits, making the products adulterated.
New guidance documents prepared by three study groups of the Global Harmonization Task Force (GHTF) should help smooth the way for more expedited device approvals and ease firms' ability to comply with foreign regulations.