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Amidst all the talk about reducing the time and scope of clinical trials to accelerate drug testing and approval, medical product development still requires researchers and regulators to “get the right answer,” says Robert Temple, deputy director for clinical science in the Center for Drug Evaluation and Research. And in the U.S., this usually involves conducting “adequate and well-controlled studies,” Temple observed in accepting an award at the annual meeting of the Food and Drug Law Institute (FDLI) last month.
Temple, long regarded as the dean of biomedical clinical research, recalled that when he came to FDA in 1972, it was common for the agency to take 36 months to approve a new drug application (NDA) -- reviewer reports were handwritten and then had to be typed up. Early trials often tested too-high doses that led to adverse reactions, leading researchers to understand the need for randomized dose response studies. Researchers and regulators also soon recognized the importance of counting all patients in a study and establishing clear statistical plans before launching trials.
Including patient sub groups in clinical research is nothing new, he observed, noting that FDA issued a rule more than 20 years ago requiring subset analysis in all NDAs. But Temple acknowledged that there’s still much discussion about how to assess responses of different patient subsets. Initially, FDA defined “elderly” as over 65 years of age, which turned out to be “completely wrong.”
Patient access to experimental drugs has been authorized by FDA since the 1980s, Temple pointed out, but usually after clinical trials were done and the NDA filed. Now with breakthrough drugs that demonstrate striking effects very early in development, there’s pressure to allow access while trials are in process, which could lead to questions about data validity. Although FDA is paying more attention to accelerating approval of drugs to treat serious illnesses by providing early consultation and greater flexibility, this “is not a new concept,” Temple commented. And we “still need good evidence.”