FDA recently held a public webinar to discuss its draft guidance recommending targeted safety data collection in certain drug trials. The presentation and slides are now available on FDA’s website.
According to FDA, selective safety data collection may:
- Improve the quality of data collected in late-phase and postmarketing clinical trials, making the information more useful
- Reduce trial costs
- Lessen administrative burden
Targeted safety data collection may be appropriate when the drug’s safety profile has been well characterized in previous trials, the pattern of adverse events has been consistent across multiple trials and there is no reason to believe it will be different in the current trial. While most trials that meet all of these criteria will be postmarketing studies, some late-phase premarketing studies may also qualify if earlier trials and phases have generated a large enough database of safety information.
The types of data that could potentially be collected/reported less frequently, or not at all, include nonserious adverse events not associated with drug discontinuation; routine laboratory testing; concomitant medications; and history and physical exams. Another option might be to collect these data in only a subset of the study population.
Whatever approach is selected, it should be identified prospectively and discussed explicitly in the protocol, along with the rationale for non-collection. Sponsors (and sponsor-investigators) contemplating targeted safety data collection are encouraged to consult with FDA during the protocol design phase.