Even Five Years Postapproval, Many Drug Studies Remain Nonpublic
Medically reviewed by Drugs.com.
By Lori Solomon HealthDay Reporter
FRIDAY, Sept. 1, 2023 -- Only a fraction of evidence from completed studies is available publicly before drugs receive U.S. Food and Drug Administration approval, according to a study published in the August issue of Health Affairs Scholar.
Robert M. Kaplan, Ph.D., from Stanford University School of Medicine in California, and colleagues reviewed availability of results prior to and during the five years following each of the 46 novel drugs approved by the FDA in 2017.
The researchers found that the 46 drugs approved in 2017 were evaluated in 1,149 studies (range, two to 165 studies; mean, 24.98). Before approval, an average of 9.22 studies were started and 5.82 studies were completed. For 19 of the 46 approvals, a single trial justified approval. An average of 1.42 studies had results publicly posted prior to FDA approval. For nine of the approved drugs, no results were publicly reported before approval.
“We’re not saying that cancer drugs need a lot more studies; just that they should show all the results or trials that are completed,” coauthor Veronica Irvin, Ph.D., M.P.H., from Oregon State University in Corvallis, said in a statement. “It doesn’t mean they wouldn’t get approved, but it means we’d have a more complete picture.”
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted September 2023
Read this next
Large Language Models May Aid Emergency Department Triage
TUESDAY, May 14, 2024 -- Large language models (LLMs) could enhance emergency department triage workflows, according to a study published online May 7 in JAMA Network...
Neighborhood Inequity Tied to More People Living With Vision Difficulty, Blindness
TUESDAY, May 14, 2024 -- Residential measures of inequity are associated with a greater number of individuals living with vision difficulty and blindness (VDB), according to a...
Elite Running Tied to Longer Life Expectancy
TUESDAY, May 14, 2024 -- Sub-four-minute mile runners have greater longevity than the general population, with results dating back as far as the 1950s, according to a study...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.