Supporting clinical trial registration and reporting requirements at academic organizations in the USA

ID: 

171

Session: 

Poster session 1

Date: 

Sunday 16 September 2018 - 12:30 to 14:00

All authors in correct order:

Mayo-Wilson E1
1 Johns Hopkins Bloomberg School of Public Health, USA
Presenting author and contact person

Presenting author:

Evan Mayo-Wilson

Contact person:

Evan Mayo-Wilson
Abstract text
Background: Systematic reviews of clinical trials aim to summarize all relevant evidence, but many clinical trials are neither registered nor reported. In 2016, 'The Final Rule' (compliance date 18 April 2017) for the Food and Drug Administration Amendments Act of 2007 (FDAAA), and a complementary policy from the National Institutes of Health (NIH), clarified and expanded trial registration and result-reporting requirements.

Objectives: To determine how universities and other organizations in the USA support clinical trial registration and results reporting.

Methods: The Protocol Registration and Results System (PRS) is used to enter information in ClinicalTrials.gov. Each study registered on ClinicalTrials.gov is associated with a 'record' of that study, which is assigned to an organization account.

Between 21 November 2016 and 1 March 2017, we surveyed PRS accounts that were classified by ClinicalTrials.gov as a 'University/Organization' in the USA. We invited one PRS administrator to complete the survey for each account. We asked them to describe the policies, procedures, and resources at their organizations that support clinical trial registration and reporting.

Results: We invited 783 eligible organization accounts with 47,701 records (studies); of those, 366 accounts (47%) with 40,351 records (85%) participated. Large organizations were more likely to participate. Few organizations have a registration (156/366; 43%) or results reporting policy (129/366; 35%). Fewer use computer software to monitor compliance (68/366; 19%). Most organizations employ less than one person to support trial registration and results reporting. This could be a 'best case' scenario given non-response and social desirability bias.

Conclusions: Systematic reviews depend on evidence from clinical trials. To improve access to information from clinical trials, organizations could: require trial registration and reporting, allocate resources (e.g. staff, software) to support registration and reporting, and ensure there are consequences for failing to follow standards for clinical research.

Patient or healthcare consumer involvement: Stakeholders were involved throughout the study. Healthcare consumers were not involved.

Relevance to patients and consumers: 

Patient and provider decisions are often based on evidence from systematic reviews of clinical trials. Unfortunately, many clinical trials are not available to support clinical decisions because they are neither registered nor reported in public databases. Although academic organizations (e.g., universities) are required to register and report many clinical trials, we found that academic organizations do have have policies and resources to help their investigators meet these requirements.