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New CTTI Project to Explore the Challenges Preventing Timely and Complete ClinicalTrials.gov Reporting

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.