Researchers surveyed nearly 7,000 physicians. Journal of the American Medical Association published the results.
Here are five points:
1. Researchers found if drugs were labeled as a breakthrough, physicians often thought the drugs were supported by stronger evidence than the law requires to achieve that designation.
2. In the survey, nine out of 10 physicians chose one hypothetical drug over another identical solely based on the breakthrough designation.
3. Of those surveyed, 52 percent falsely believed that strong evidence from randomized trials is needed to achieve breakthrough designation.
4. Researchers also found a widespread lack of understanding about what FDA approval for a new drug means. Nearly seven in 10 physicians believed FDA approval entailed comparable effectiveness to other approved drugs, and statistically significant and clinically important effects.
5. However, FDA approval does not necessarily mean it is tested against other available drugs. The drug may be detested against placebo.
More articles on quality & infection control:
Pharmaceutical Research and Manufacturers of America supports part of Clinton’s drug proposal — 4 insights
CDC: Zika more serious than initial estimates — 5 notes
ASC infection control: Sterilization wraps vs. rigid containers — Which is best?
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.