In some late-stage, pre-market and post-market clinical trials, a drug safety profile may already be established and comprehensive data should not be required, the FDA said.
“Encouraging more selective or targeted safety data collection in certain clinical trials and post-market safety evaluations is also consistent with FDA’s evolving overall approach to safety assessment, which emphasizes quality over quantity,” the agency wrote.
The FDA has allowed for selective or specifically targeted data collection on a case-by-case basis in clinical trials in the past, according to the draft guidance. The agency noted that there is a “growing interest and need for larger, simpler trials to obtain outcome data, data on long-term effects of drugs, and comparative effectiveness and safety.”
Data collection that is not useful or “arduous and excessive” may act as a disincentive to clinical investigators, the FDA said in the draft guidance. The FDA is accepting comments until April 10.