Increased flexibility observed in the evidence of pre-approval of new drugs

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Characteristics of acceptable evidence of pre-approval have been more flexible for new drugs approved by the U.S. Food and Drug Administration in 2020, according to a research letter published online May 17 in JAMA open network.

Maiuha Mitra-Majumdar, MD, of Brigham Women’s Hospital and Harvard Medical School in Boston, and colleagues described the state of the evidence at the time of approval of 49 new therapies approved in 2020, supported by 75 core trials.

The researchers found that 28 of the drugs (57.1 percent) were supported by one key study. The size of the trials ranged from 19 to 2,230 participants. Seventy-six percent of the studies had a randomization component; 61.3 percent were in double masks. The advantage approach was used in most trials. About half of the trials (52.0 percent) compared the new therapeutic approach with placebo or vehicle control, while 17.3, 2.7, and 28.0 percent, respectively, used active control, both placebo and active control, and historical, external, or other control was used. Nearly half of the trials (45.3 percent) used the surrogate measure as the main endpoint. In the main trials supporting oncology claims, historical control data (72.2 vs. 14.0 percent) were significantly more common than in non-cancer claims, and at least one surrogate measure was most often used as the primary endpoint (94, 4 vs. 29.8 percent). Forty drugs had at least one claim or commitment after sale, amounting to 178 in the cohort.

“Without a reasonable likelihood that these drugs provide significant clinical benefits, the argument for faster admission becomes less convincing,” the authors write.


Tests confirming FDA approval of breakthrough drugs are reviewed


Additional information:
Abstract / Full text

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