
- Applied Clinical Trials-12-01-2018
- Volume 27
- Issue 12
FDA Clarifies Research Policies to Facilitate New Drug Development
New FDA guidances outlining recommended approaches for clinical testing methods and collecting research data, alongside with public workshops and meetings, accelerate reviews to speed new therapies to market.
This past year brought kudos to the biopharmaceutical research community, as manufacturers tested, and FDA approved, multiple innovative medical products, including important new cancer treatments, vaccines, cellular and gene therapies, and complex generics and biosimilars. Such advances have benefited from FDA efforts to streamline clinical testing methods, clarify regulatory policies, and accelerate application reviews to speed new therapies to market. FDA Commissioner Scott Gottlieb has emphasized the need to moderate the cost and time for developing new medicines to help bring down drug costs and spending. This objective has fueled agency efforts to update research policies, issue more draft and final guidances on investigative strategies, and to meet more often with sponsors and with stakeholders to advance development programs.
One visible result is a wave of new guidances outlining recommended approaches for testing certain types of drugs and for collecting research data. Recent draft guidances from the Center for Drug Evaluation and Research (CDER), for example, discuss endpoints for prostate cancer studies, meta-analyses for evaluating drug safety, methods for developing drugs to treat chronic hepatitis B, and use of certain markers in assessing metabolic malignancies (new CDER guidances listed
FDA also has held
A main challenge for sponsors is to achieve timely enrollment in clinical trials of sufficient numbers of qualifying patients. FDA is assessing study inclusion and exclusion criteria to identify barriers to increased diversity in study populations, including women and elderly patients. One recent guidance advises on enrolling adolescents in adult studies as part of efforts to include more under-represented patients in trials. And to reduce the complexity of research requirements, FDA recently proposed to limit informed consent requirements for studies that involve minimal risk to participants, as determined by institutional review boards.
To expedite the review of applications for cutting-edge therapies, the agency
Further efficiencies are the goal of a
Jill Wechsler is the Washington Correspondent for Applied Clinical Trials
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