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

Evan R Mayo-Wilson, James Heyward, Anthony Keyes, Jesse Reynolds, Sarah White, Nidhi Atri, George Caleb Alexander, Audrey Omar, Daniel E Ford

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Article number60
JournalBMC Medicine
Volume16
Issue number1
DOIs
StatePublished - May 2 2018

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Clinical Trials
Organizations
Compliance
Surveys and Questionnaires
Administrative Personnel
Software
Research Personnel
Social Desirability
Research Ethics Committees
National Institutes of Health (U.S.)
United States Food and Drug Administration
Health Policy

Keywords

  • Clinical trials
  • Reporting bias
  • Results reporting
  • Trial registration

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Clinical trial registration and reporting : A survey of academic organizations in the United States. / Mayo-Wilson, Evan R; Heyward, James; Keyes, Anthony; Reynolds, Jesse; White, Sarah; Atri, Nidhi; Alexander, George Caleb; Omar, Audrey; Ford, Daniel E.

In: BMC Medicine, Vol. 16, No. 1, 60, 02.05.2018.

Research output: Contribution to journalArticle

Mayo-Wilson, Evan R ; Heyward, James ; Keyes, Anthony ; Reynolds, Jesse ; White, Sarah ; Atri, Nidhi ; Alexander, George Caleb ; Omar, Audrey ; Ford, Daniel E. / Clinical trial registration and reporting : A survey of academic organizations in the United States. In: BMC Medicine. 2018 ; Vol. 16, No. 1.
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AU - Heyward, James

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AU - Reynolds, Jesse

AU - White, Sarah

AU - Atri, Nidhi

AU - Alexander, George Caleb

AU - Omar, Audrey

AU - Ford, Daniel E

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