20 - Cultivating a Culture of Compliance with Clinical Trials Disclosure on ClinicalTrials.gov

Background:  Under a finite workforce and tight resources, the challenge of maintaining compliance with numerous clinical trials disclosures at ClinicalTrials.gov can appear daunting and unfeasible. The Human Research Protection Program (HRPP) at a university implemented an innovative approach that shifted the state into a win-win situation for investigators and the institution.

Methods:  The Human Research Protection Program (HRPP) at Rutgers University is responsible for quality assurance reviews of human research studies. In 2013, the Program was tasked with the oversight of the required registration and results reporting at ClinicalTrials.gov. In 2017, the Program expanded their existing routine review procedures by adding a ClinicalTrials.gov-focused Routine Review. This innovative hybrid approach aims to 1) monitor the compliance with FDAAA801, and 2) provide indispensable support for investigators to act timely and to fully meet the requirements of the federal regulations.
As an additional category of routine review, applicable interventional studies (i.e., “Applicable Clinical Trials (ACTs)” and “probably Applicable Clinical Trials (pACTs)”) required to meet compliance of FDAAA801 within ClinicalTrials.gov were provided a routine review conducted by the HRPP. The standard procedures were followed with an overview session that outlined the requirements of responsible party per the institutional policy and the federal regulations. All applicable studies were monitored through their research cycle accordingly.
In May 2023, a subsequent review of study records was conducted and the results reporting status were recorded.

Results:  
1. Between May 2017 and June 2019, a total of 18 Principal Investigators whose 24 studies were selected and reviewed through the HRPP ClinicalTrials.gov-focused routine review procedures.
2. For the stage at the time of the initial review, among the 10 ACTs, one was at Before, and 9 During; among the 14 pACTs, two were at During, and 12 After.
3. Five of the 10 ACTs and 11 of the 14 pACTs are oncology studies.
4. Two late registrations (both ACTs) were identified at the time of the initial review and rectified to completion.
5. The Table summarizes the numbers of clinical trials requiring results to be submitted in time that were submitted either on time, late, or not submitted at all, at the time points of initial review conducted during May 2017 through August 2019, and the subsequent review in May 2023.
6. At the initial review, 11 pACTs did not submit results at all, 3 pACT and all 10 ACTs had forthcoming results reporting due dates.
7. At the subsequent review, 1 pACT and 3 ACTs submitted the results on time, 12 pACTs and 0 ACT submitted late, 1 pACT and 2 ACTs not submitted at all.
8. A total of 18 Principal Investigators (PIs) were interviewed during the initial review period. Of which, a total of 15 PIs had a single study and 3 PIs had multiple studies, respectively, for review.
9. The subsequent review found that 6 PIs were no longer affiliated with the institution, and one PI was severely impacted by COVID and as a result impeded the corresponding results reporting responsibility.

Limitations: Since the status of compliance is required to be maintained throughout a period dictated by the study’s research cycle, the findings of this study are limited by the time points of the data collection. These time points were 1) the time of the initial review and 2) the subsequent review conducted by the HRPP analyst/ ClinicalTrials.gov PRS Administrator.

Discussion:  The main takeaway is the earlier the ClinicalTrials.gov-focused routine review is conducted, the higher chance the investigator/ protocol may achieve compliance in its research cycle. Findings of these routine reviews have been regularly provided to the senior management for infrastructure support update which is essential for investigators. Besides an increase in registration, data reporting, and a reduction in problematic items, investigators now view HRPP as a valuable partner and resource, not merely a compliance overseer. The dissemination of routine review findings continues to enhance institutional compliance with federal regulations FDAAA801 and NIH Policy to uphold protection of human subjects in clinical research.