The United States Food Drug Administration’s Innovative Alternative Tools to Evaluate Good Clinical Practice During the COVID-19 Public Health Emergency

Abstract

BackgroundThe COVID-19 public health emergency limited the U.S. Food and Drug Administration’s ability to conduct on-site good clinical practice (GCP) inspections. Alternative tools therefore have been used by FDA during the pandemic to evaluate the reliability and integrity of clinical trial data for marketing applications. However, no systematic assessment of the pandemic impact on in-person GCP inspections has been conducted. In addition, the alternative tools and their contribution to GCP oversight have not been reported.   MethodsThis retrospective study reviewed databases internal to FDA and identified and characterized alternative tools used in lieu of on-site GCP inspections in fiscal year (FY)*2020 and FY2021. The impact of the pandemic on on-site GCP inspections and the contribution of alternative tools to overall GCP activities** were described. ResultsBetween April 13, 2020, and September 30, 2021, FDA conducted 77 GCP evaluations using alternative tools. Alternative tools were used most commonly for GCP evaluations of non-U.S. clinical investigators in support of mission critical, original New Drug Applications (NDAs). FDA conduced 370 on-site GCP inspections in FY2020 and 451 in FY2021, which represented a 23% and 6% decrease, respectively, compared to the yearly average of 481 on-site GCP inspections in the 5 years preceding the pandemic. The use of alternative tools contributed 10% and 8% to total GCP activities in FY2020 and FY2021, respectively.ConclusionGCP evaluations using alternative tools have played a significant role in GCP activities supporting the review of marketing applications during the COVID-19 public health emergency. KeywordsCOVID-19 pandemic, public health emergency, remote regulatory assessment (RRA), good clinical practice, remote inspection, FDA. *Fiscal year is defined as from October 1 to September 30.**GCP activities in this paper refers to on-site inspections and GCP evaluations using alternative tools conducted by the Office of Regulatory Affairs or the GCP Assessment Branch in the Division of Clinical Compliance Evaluation in the Office of Scientific Investigations in support of marketing applications submitted to the Center for Drug Evaluation and Research at FDA.