Clinical trial registration and reporting: a survey of academic organizations in the United States

Evan Mayo-Wilson, James Heyward, Anthony Keyes, Jesse Reynolds, Sarah White, Nidhi Atri, G Caleb Alexander, Audrey Omar, Daniel E Ford, National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee, Nidhi Atri, Hila Bernstein, Yolanda P Davis, Keren Dunn, Carrie Dykes, James Heyward, M E Blair Holbein, Anthony Keyes, Evan Mayo-Wilson, Jesse Reynolds, Leah Silbert, Niem-Tzu Rebecca Chen, Sarah White, Diane Lehman Wilson, Evan Mayo-Wilson, James Heyward, Anthony Keyes, Jesse Reynolds, Sarah White, Nidhi Atri, G Caleb Alexander, Audrey Omar, Daniel E Ford, National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee, Nidhi Atri, Hila Bernstein, Yolanda P Davis, Keren Dunn, Carrie Dykes, James Heyward, M E Blair Holbein, Anthony Keyes, Evan Mayo-Wilson, Jesse Reynolds, Leah Silbert, Niem-Tzu Rebecca Chen, Sarah White, Diane Lehman Wilson

Abstract

Background: Many clinical trials conducted by academic organizations are not published, or are not published completely. Following the US Food and Drug Administration Amendments Act of 2007, "The Final Rule" (compliance date April 18, 2017) and a National Institutes of Health policy clarified and expanded trial registration and results reporting requirements. We sought to identify policies, procedures, and resources to support trial registration and reporting at academic organizations.

Methods: We conducted an online survey from November 21, 2016 to March 1, 2017, before organizations were expected to comply with The Final Rule. We included active Protocol Registration and Results System (PRS) accounts classified by ClinicalTrials.gov as a "University/Organization" in the USA. PRS administrators manage information on ClinicalTrials.gov. We invited one PRS administrator to complete the survey for each organization account, which was the unit of analysis.

Results: Eligible organization accounts (N = 783) included 47,701 records (e.g., studies) in August 2016. Participating organizations (366/783; 47%) included 40,351/47,701 (85%) records. Compared with other organizations, Clinical and Translational Science Award (CTSA) holders, cancer centers, and large organizations were more likely to participate. A minority of accounts have a registration (156/366; 43%) or results reporting policy (129/366; 35%). Of those with policies, 15/156 (11%) and 49/156 (35%) reported that trials must be registered before institutional review board approval is granted or before beginning enrollment, respectively. Few organizations use computer software to monitor compliance (68/366; 19%). One organization had penalized an investigator for non-compliance. Among the 287/366 (78%) accounts reporting that they allocate staff to fulfill ClinicalTrials.gov registration and reporting requirements, the median number of full-time equivalent staff is 0.08 (interquartile range = 0.02-0.25). Because of non-response and social desirability, this could be a "best case" scenario.

Conclusions: Before the compliance date for The Final Rule, some academic organizations had policies and resources that facilitate clinical trial registration and reporting. Most organizations appear to be unprepared to meet the new requirements. Organizations could enact the following: adopt policies that require trial registration and reporting, allocate resources (e.g., staff, software) to support registration and reporting, and ensure there are consequences for investigators who do not follow standards for clinical research.

Keywords: Clinical trials; Reporting bias; Results reporting; Trial registration.

Conflict of interest statement

Ethics approval

The Johns Hopkins School of Public Health Institutional Review Board (FWA#0000287) determined that the study was not human subjects research (00007429).

Competing interests

AK, JR, and SW completed the survey on behalf of their organizations.

AK chairs the National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee. AK and SW co-chair the National Clinical Trials Registration and Results Reporting Taskforce. AK and NA are Protocol Registration and Results System (PRS) administrators for the “Johns Hopkins University” account. JR and AO are PRS administrators for the “Yale University” account. When we conducted this study, SW was a PRS administrator for the “Brigham and Women’s Hospital,” “Massachusetts General Hospital,” and “McLean Hospital” accounts. SW is currently the Executive Director of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart: PRS accounts included in the survey

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