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

BMC Medicine

on behalf of the National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee¹  Anthony Keyes²  Evan Mayo-Wilson³  James Heyward³  G. Caleb Alexander⁴  Sarah White⁵  Daniel E. Ford⁶  Nidhi Atri⁶  Audrey Omar⁷  Jesse Reynolds⁷ 

[1] ;Clinical Research Projects, Johns Hopkins University School of Medicine;Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health;Departments of Epidemiology and Medicine, Johns Hopkins University Bloomberg School of Public Health;Human Research Quality Improvement Program, Partners HealthCare;Johns Hopkins University School of Medicine;Yale Center for Analytical Studies;

关键词: Clinical trials;    Trial registration;    Results reporting;    Reporting bias;   

DOI  :  10.1186/s12916-018-1042-6

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown