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

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 clarifie...

Full description

Bibliographic Details
Main Authors: Evan Mayo-Wilson, James Heyward, Anthony Keyes, Jesse Reynolds, Sarah White, Nidhi Atri, G. Caleb Alexander, Audrey Omar, Daniel E. Ford, on behalf of the National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee
Format: Article
Language:English
Published: BMC 2018-05-01
Series:BMC Medicine
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12916-018-1042-6
id doaj-bcb72671c9aa480aa84078d401041e37
record_format Article
spelling doaj-bcb72671c9aa480aa84078d401041e372020-11-24T21:46:01ZengBMCBMC Medicine1741-70152018-05-0116111310.1186/s12916-018-1042-6Clinical trial registration and reporting: a survey of academic organizations in the United StatesEvan Mayo-Wilson0James Heyward1Anthony Keyes2Jesse Reynolds3Sarah White4Nidhi Atri5G. Caleb Alexander6Audrey Omar7Daniel E. Ford8on behalf of the National Clinical Trials Registration and Results Reporting Taskforce Survey SubcommitteeDepartment of Epidemiology, Johns Hopkins University Bloomberg School of Public HealthDepartment of Epidemiology, Johns Hopkins University Bloomberg School of Public HealthClinical Research Projects, Johns Hopkins University School of MedicineYale Center for Analytical StudiesHuman Research Quality Improvement Program, Partners HealthCareJohns Hopkins University School of MedicineDepartments of Epidemiology and Medicine, Johns Hopkins University Bloomberg School of Public HealthYale Center for Analytical StudiesJohns Hopkins University School of MedicineAbstract 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.http://link.springer.com/article/10.1186/s12916-018-1042-6Clinical trialsTrial registrationResults reportingReporting bias
collection DOAJ
language English
format Article
sources DOAJ
author Evan Mayo-Wilson
James Heyward
Anthony Keyes
Jesse Reynolds
Sarah White
Nidhi Atri
G. Caleb Alexander
Audrey Omar
Daniel E. Ford
on behalf of the National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee
spellingShingle Evan Mayo-Wilson
James Heyward
Anthony Keyes
Jesse Reynolds
Sarah White
Nidhi Atri
G. Caleb Alexander
Audrey Omar
Daniel E. Ford
on behalf of the National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee
Clinical trial registration and reporting: a survey of academic organizations in the United States
BMC Medicine
Clinical trials
Trial registration
Results reporting
Reporting bias
author_facet Evan Mayo-Wilson
James Heyward
Anthony Keyes
Jesse Reynolds
Sarah White
Nidhi Atri
G. Caleb Alexander
Audrey Omar
Daniel E. Ford
on behalf of the National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee
author_sort Evan Mayo-Wilson
title Clinical trial registration and reporting: a survey of academic organizations in the United States
title_short Clinical trial registration and reporting: a survey of academic organizations in the United States
title_full Clinical trial registration and reporting: a survey of academic organizations in the United States
title_fullStr Clinical trial registration and reporting: a survey of academic organizations in the United States
title_full_unstemmed Clinical trial registration and reporting: a survey of academic organizations in the United States
title_sort clinical trial registration and reporting: a survey of academic organizations in the united states
publisher BMC
series BMC Medicine
issn 1741-7015
publishDate 2018-05-01
description 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.
topic Clinical trials
Trial registration
Results reporting
Reporting bias
url http://link.springer.com/article/10.1186/s12916-018-1042-6
work_keys_str_mv AT evanmayowilson clinicaltrialregistrationandreportingasurveyofacademicorganizationsintheunitedstates
AT jamesheyward clinicaltrialregistrationandreportingasurveyofacademicorganizationsintheunitedstates
AT anthonykeyes clinicaltrialregistrationandreportingasurveyofacademicorganizationsintheunitedstates
AT jessereynolds clinicaltrialregistrationandreportingasurveyofacademicorganizationsintheunitedstates
AT sarahwhite clinicaltrialregistrationandreportingasurveyofacademicorganizationsintheunitedstates
AT nidhiatri clinicaltrialregistrationandreportingasurveyofacademicorganizationsintheunitedstates
AT gcalebalexander clinicaltrialregistrationandreportingasurveyofacademicorganizationsintheunitedstates
AT audreyomar clinicaltrialregistrationandreportingasurveyofacademicorganizationsintheunitedstates
AT danieleford clinicaltrialregistrationandreportingasurveyofacademicorganizationsintheunitedstates
AT onbehalfofthenationalclinicaltrialsregistrationandresultsreportingtaskforcesurveysubcommittee clinicaltrialregistrationandreportingasurveyofacademicorganizationsintheunitedstates
_version_ 1725902576957784064