Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements

Expert Meetings

Overview

Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov is an important part of providing patients, providers, researchers, and the public with access to information about clinical trials and their results. 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, CTTI collaborated with the U.S. Food and Drug Administration (FDA) in a project to understand barriers to trial information submission for timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov. The project involved in-depth stakeholder interviews and a survey to identify and explore the key challenges to registration and reporting of summary results information for applicable clinical trials and to examine potential solutions. 

After the relevant themes were assessed, CTTI condensed these findings into a report containing strategies and recommendations for improving registration and reporting of summary results information for applicable clinical trials, including taking proactive approaches to comply with regulatory requirements, keeping principal investigators and study teams informed, providing education and guidance about how to meet requirements, and more. Read the full report for a complete list of strategies.  

CTTI is also using this information to develop a list of resources to provide assistance with registering applicable clinical trials and reporting results information on ClinicalTrials.gov.  

News

Case Study

    In Detail