Author Interviews, FDA, JAMA, Yale / 23.01.2014
FDA Drug Approvals Have Variable Clinical Trial Evidence Record
MedicalResearch.com Interview with:
Nicholas S. Downing, AB
Yale University School of Medicine
New Haven, Connecticut
MedicalResearch.com: What are the main findings of the study?
Answer: In our systematic review of all new drugs approved by the FDA over an 8 year period, we found that there was real variability in the quality and quantity of clinical trial evidence used as the basis of the agency’s approval decisions. Some drugs were studied in multiple randomized, double-blinded, controlled clinical trials that provide very helpful information for patients and physicians. However, other drugs were studied in clinical trials that did not produce as much information about their safety and effectiveness.
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