Abstract: Since 2021, the FDA and the NIH have increased citations and notifications for non-compliance with required results reporting on ClinicalTrials.gov. Many studies still do not submit results to ClinicalTrials.gov; some do not publish results after 3 years following study completion. Institutions are limited by a system that provides useful data, but additional steps are required to plan for future actions. Some institutions develop procedures that are not reproducible elsewhere. Private companies have developed software to monitor compliance with a cost. To date, there are a lack of low cost solutions to help institutions remain compliant. The Clinical Trials Dashboard aims to increase compliance by making tracking registration and results status simple, transparent, and reproducible. A user uploads the csv files downloaded from the Protocol Registration and Results System and the dashboard merges, aggregates, and flags studies for review. Downloads include retrospective report as displayed in the dashboard; prospective results, including NIH-defined clinical trials, due in next quarter; and a file with parsed contact information to plan compliance activity.
Speaker: Kaitlin Maciejewski and Jesse Reynolds
Affiliation: Yale Center for Analytical Sciences
Title: Clinical Trials Reporting Dashboard
Abstract_Sanitzed: Since 2021, the FDA and the NIH have increased citations and notifications for non-compliance with required results reporting on ClinicalTrials.gov. Many studies still do not submit results to ClinicalTrials.gov; some do not publish results after 3 years following study completion. Institutions are limited by a system that provides useful data, but additional steps are required to plan for future actions. Some institutions develop procedures that are not reproducible elsewhere. Private companies have developed software to monitor compliance with a cost. To date, there are a lack of low cost solutions to help institutions remain compliant. The Clinical Trials Dashboard aims to increase compliance by making tracking registration and results status simple, transparent, and reproducible. A user uploads the csv files downloaded from the Protocol Registration and Results System and the dashboard merges, aggregates, and flags studies for review. Downloads include retrospective report as displayed in the dashboard; prospective results, including NIH-defined clinical trials, due in next quarter; and a file with parsed contact information to plan compliance activity.