clinical researchRecent comments from FDA officials and industry leaders suggest a shift in the conceptualization of what constitutes reliable clinical research. Data used to make regulatory decisions may soon be pulled from non-traditional data sources outside of standard clinical studies. Applied Clinical Trials reports that while the randomized, prospective placebo controlled trial remains at the “top of the pyramid” for reliability of evidence, new tools for collecting data and methodologies for evaluating different forms of information requires FDA to adapt to this new information matrix, said FDA commissioner Scott Gottlieb at a recent workshop on the Impact of Real World Evidence on Medical Product Development at the National Academy of Sciences, Engineering, and Medicine (NASEM).1

Gottlieb’s comments come on the heels of an onslaught of criticism launched at pharmaceutical companies due to rising costs of drugs. The director of the Center for Drug Evaluation and Research (CDER), Janet Woodcock, went so far as to call the U.S. clinical trial system as “broken” and will “continue to be a barrier to innovation and to quality of care around the world” if new clinical trial platforms capable of generating necessary evidence more time and cost-efficiently are not established. Even former FDA commissioner Robert Califf lamented that the current system is “bloated and burdened [and is] not generating the evidence that is needed.”1

Any changes to the current clinical research system, small or large, will reverberate throughout the industry. New seminal guidance on good clinical practices (GCPs) may need re-written, data collection methods will need to be retooled or updated, new standard operating procedures (SOPs) would need to be adopted by sites and sponsors, etc. Gottlieb considers a broad adoption of real world evidence (RWE) from patient health care records as one possible solution. Using abundant and more readily-available RWE to inform medical product development could supplement clinical trial evidence for certain products, decreasing time and cost of development. Applied Clinical Trials also reports that FDA and sponsors are exploring other approaches such as pragmatic clinical trials, master protocols, and clinical trial networks able to assess multiple products on a range of patients.

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