Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis

Area of Science:

• Clinical trial methodology
• Biomedical research reporting standards

Background:

• Master protocol research programs (MPRPs) present unique reporting challenges due to their complex, multi-substudy designs.
• Existing trial registries and reporting systems are often designed for single-protocol studies, hindering effective MPRP data submission.

Purpose of the Study:

• To describe a structured approach for reporting MPRPs that aligns with good reporting practices.
• To facilitate clear communication of the overall master protocol and individual substudy designs.
• To enhance the discoverability and accessibility of MPRP results.

Main Methods:

• Qualitative analysis of existing reporting practices and challenges.
• Review of master protocol research program characteristics and examples.
• Development of a proposed reporting framework.

Main Results:

• A novel reporting approach is proposed, utilizing separate registration records for each substudy within an MPRP.
• This method accommodates the complexity of MPRPs, enabling structured reporting of substudy designs and results.
• The approach supports clear, descriptive, and timely reporting of trial outcomes.

Conclusions:

• The proposed reporting strategy enhances clarity and efficiency for master protocol research programs.
• This approach is applicable across various trial registries and results databases, promoting global harmonization.
• Further discussion and adoption are encouraged to improve the reporting of complex clinical trial programs.