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

ABSTRACT:

Objective

To describe an approach for reporting master protocol research programs (MPRPs) that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy.

Design

Qualitative analysis.

Data sources

ClinicalTrials.gov trial registry.

Main outcome measures

Established goals and related practices of the trial reporting system were outlined, examples and key characteristics of MPRPs were reviewed, and specific challenges in registering and reporting summary results to databases designed for traditional clinical trial designs that rely on a model of one study per protocol were identified.

Results

A reporting approach is proposed that accommodates the complex study

SUBMITTER: Williams RJ 

PROVIDER: S-EPMC9186156 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature