Improving Registration and Reporting Summary Results Information for Clinical Trials

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

The FDA is announcing a newly published report on the Clinical Trials Transformation Initiative (CTTI) prepared on the findings of a collaborative project with FDA to understand the barriers to timely, accurate and complete registration and reporting of summary results information for applicable clinical trials. According to the report, the major challenge was a lack of understanding on the part of the Responsible Party regarding the types of trials that must be registered, when the trial should be registered, and when and for which trials summary results information must be submitted.

Challenges Related to Registering Clinical Trials and Reporting of Summary Results Information

Timely, accurate, and complete registration and reporting of summary results information for clinical trials (CTs) is an important part of providing patients, providers, researchers, and the public with access to information about CTs and their results. Despite the regulatory requirements for CTs and the importance of enhancing transparency while increasing knowledge of potential new treatments, multiple publications have reported gaps in CT registration and results information submission to the data bank. 

To address this issue, the CTTI collaborated with the FDA in a project to understand barriers to trial information submission and reporting of summary results information. 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 to examine potential solutions.

The major challenge was a lack of understanding on the responsibilities regarding

• the types of trials that must be registered,
• when the trial should be registered, and
• when and for which trials summary results information must be submitted.

Survey respondents also reported challenges relating to non-responsive principal investigators or study leads, which hindered both timely registration and reporting of summary results information. In addition, challenges related to the clarity of the requirements, organizational policies, and lack of harmonization were reported.

The CTTI condensed these findings into a report containing strategies and recommendations for improving registration and reporting of summary results information, 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.    

More information is provided in Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information on ClinicalTrials.gov.