CTTI Project: Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements
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:
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:
For more information, see CTTI’s Project page: Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements.
The ClinicalTrials.gov Reporting Challenges Project is conducting a survey following in-depth interviews that were conducted in late 2021. We invite individuals who provide oversight, register, and/or report trial results information on ClinicalTrials.gov to complete the survey. You may also forward this survey to others who you know register and/or report clinical trial information on ClinicalTrials.gov.
Additional information for potential survey participants is provided below.
What are you being invited to do?
CTTI is conducting a survey to learn more about organizations’ experiences with registering and reporting clinical trial information on ClinicalTrials.gov.
We invite individuals at organizations such as academic institutions, medical product companies, government agencies, and non-government organizations who provide oversight, register, and/or report trial results information on ClinicalTrials.gov to complete the survey.
The survey focuses on policies and approaches your organization implements to comply with ClinicalTrials.gov regulatory requirements, as well as the advantages and disadvantages of your approaches, challenges faced, and suggested strategies for addressing challenges.
How will CTTI use the information?
CTTI will outline useful practices for improving the reporting of timely, accurate, and complete registration and results information on ClinicalTrials.gov.
Your name and organization will not be included when CTTI reports the survey findings. CTTI will send the FDA an aggregated summary of survey findings to inform their approach to supporting more complete reporting of clinical trial information.
Interested in participating?
If you provide oversight, register, and/or report clinical trial information on ClinicalTrials.gov, please click on this link to take the survey.
You may also forward this survey to others who you know register and/or report clinical trial information on ClinicalTrials.gov.
Have questions?
For questions about this survey, please email CTTI Project Manager Kelly Franzetti.
Timely and complete registration and results reporting of clinical trial information is an important part of keeping patients, providers, researchers, and the public informed about clinical trials. The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that the responsible party for an applicable clinical trial register and submit results information for the trial to the ClinicalTrials.gov databank to promote transparency and accountability, in an effort to limit duplicity and encourage others to build on results. Despite the importance of this goal, public reporting has suggested that not all clinical trials are registered in a timely manner or have incomplete results.
To address this problem, CTTI is launching a new project to identify the challenges that lead to late registration and incomplete or missing results information for applicable clinical trials. The project will use in-depth stakeholder interviews and surveys to identify and explore the key challenges to timely submission of clinical trial information and identify potential solutions. The project will explore factors other than those related to the ClinicalTrials.gov platform and is intended to be complementary to the National Library of Medicine’s ClinicalTrials.gov Modernization initiative.
CTTI will use this data to develop informed best practices for responsible parties and other stakeholders. The findings from this project may also provide potential ways to support responsible parties in meeting the registration and results reporting requirements.
