Reference:
Demasi, M. (2022). FDA oversight of clinical trials is “grossly inadequate,” say experts. BMJ, 379, o2628. http://doi.org/10.1136/bmj.o2628
Summary:
Experts are raising alarms about the US Food and Drug Administration’s (FDA) oversight of clinical trials, particularly following the expedited development of Covid-19 vaccines. A complaint by Brook Jackson, a former employee at Ventavia Research Group, highlighted serious issues, including falsified data and inadequate training of staff, at several trial sites. Alarmingly, only a small fraction of Pfizer, Moderna, and remdesivir trial sites were inspected prior to product approval. Critics argue that the FDA’s lack of inspection and transparency poses significant risks to public health. Historical data indicate that the FDA has consistently failed to adequately oversee clinical trials, with less than 1% audited between 2000 and 2005. Furthermore, a substantial number of trials with reported violations remain unaddressed in published literature, raising concerns about the integrity of the data. Experts call for improved regulatory practices and transparency to ensure public safety in drug approvals, emphasizing the need for the FDA to act decisively in the face of misconduct.