CTTI and FDA Share Strategies for Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information for Applicable Clinical Trials on ClinicalTrials.gov

Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders. Despite the regulatory requirements for applicable clinical trials and the importance of fostering transparency while increasing knowledge of potential new treatments in development, multiple publications have reported gaps in clinical trial registration and results information submission to the data bank.  

To address this issue, the Clinical Trials Transformation Initiative (CTTI) collaborated with the Food and Drug Administration (FDA) on a project to understand the barriers to timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov. The project involved in-depth interviews and a survey to identify the range of barriers and their salience by type of stakeholder, root causes influencing barriers, and potential solutions and helpful practices to implement moving forward. After the relevant themes were assessed, CTTI surveyed 92 individuals who represented 84 unique organizations and condensed this information into a report containing strategies and recommendations for improving registration and reporting. 

Some of the strategies include: 

• Use a centralized/dedicated approach to meeting ClinicalTrials.gov requirements  
• Take a proactive, rather than reactive, approach to complying with ClinicalTrials.gov regulatory requirements 
• Escalate to upper levels of leadership for PIs/study teams that are non-responsive to the administrative unit’s communication about compliance  
• Inform PIs/study teams  
  • about the possibility of civil money penalties for non-compliance with ClinicalTrials.gov regulatory requirements;  
  • that submitting results information on ClinicalTrials.gov is separate from publishing results; and 
  • that, per ICMJE, reporting results information on ClinicalTrials.gov does not preclude publishing results in journals 
• Provide education, resources, guidance, and support about meeting ClinicalTrials.gov requirements to PIs/study teams and other research personnel 

See the full report for a complete list of strategies. 

When describing challenges with registering and reporting summary results information from applicable clinical trials, respondents cited several major challenges: 

• A lack of understanding on the part of the Principal Investigator (PI) and their study team regarding  
  • the type of trial that must be registered,  
  • which trial results must be submitted,  
  • and when they should be registered.  
• Administrative groups also reported challenges relating to non-responsive PIs and study teams, which hinders both timely registering and reporting of results.  
• For reporting, PIs and study teams responding to the survey also expressed concerns about waiting until all data are analyzed before reporting results information on ClinicalTrials.gov to prevent discrepancies between ClinicalTrials.gov data and published results. 

For more information, see CTTI’s Project page: Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements.