Posted by Michael Wonder on 23 Apr 2020
Increasing access to FDA inspection reports on irregularities and misconduct in clinical trials
23 April 2020 - Transparency related to clinical trial protocols and data has become the expected standard over the past 2 decades, with broad support from patients, the scientific community, and regulatory agencies.
Requirements for trial disclosures are codified in US statute and, since 2017, regulation requires timely submission of trial results to ClinicalTrials.gov.
However, meaningful clinical trial transparency extends beyond prospective registration and reporting results. The public, for example, must know whether trials were conducted according to international standards for research integrity and must have access to reports investigating departures from good clinical practice guidelines.
