Advancing the Quality of Clinical Trial Enterprise

Evidence that substantial numbers of trials do not contribute meaningful information to the evidence base raises both ethical and scientific concerns. Participants assume the risks and burdens of a study, while mistakenly believing that they are contributing to medical progress. At the same time, these non-informative trials divert participants, researchers, and other resources from more valuable trials, potentially making it more difficult to reach enrollment targets.

Although others have identified the conduct of non-informative trials as a significant problem, there has been less progress in defining, studying, and attempting to reduce their frequency and thus improve the quality of the medical evidence base. This program focuses on efforts to improve the efficiency and quality of clinical trials, with the overall objective of optimizing the impact of each trial participant and informing key medical and policy decisions. In addition, we build on the established foundation of trial reporting to ClinicalTrials.gov with the aims of improving the timeliness and quality of reports, as well as increasing the use of data from ClinicalTrials.gov by the research enterprise.

Objectives

Develop “best practices” for the conduct of landscape analyses that enable researchers and other oversight entities to understand what is already known, and what is currently being investigated, about their research question
Analyze large samples of informed consent forms in order to establish better (and worse) practices, and to start to develop tools that might help researchers to write future consent forms
Increase use of data from ClinicalTrials.gov to inform research decisions

key Milestones

April 2023: Co-authored article “How to limit uninfomative trials: Results from a Delphi working group”
April 2022: Co-authored article “Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis”
February 2022: Co-authored article “Reporting of Clinical Trial Results: Aligning Incentives and Requirements to Do the Right Thing”
November 2021: Co-authored article “Characterization of Informed Consent Forms Posted on ClinicalTrials.gov”
October 2021: Co-authored article “Monitoring the Pediatric Clinical Trials Enterprise”
May 2021: Co-authored article “Trial Reporting and the Clinical Trials Enterprise”
April 2021: Served on NASEM committee which released a report on genomic epidemiology data infrastructure; co-authored article “Lack of harmonization of coronavirus disease ordinal scales”
January 2021: Contributed to article “Complete, Rapid Reporting of Clinical Trials: A Necessary Component of the Pandemic Response”
December 2020: Co-authored letter to the editor “Lack of harmonization of coronavirus disease ordinal scales”
April 2020: Co-authored white paper “Diagnostic Testing for COVID-19 Considering False Positive and False Negative Results”
March 2020: Co-authored article “Time for NIH to lead on data sharing”
January 2020: Co-authored article “Issues in the registration of database studies”

Project leadership & STAFF

Deborah Zarin, MD, Program Director, Advancing the Clinical Trial Enterprise, MRCT Center
Barbara E. Bierer, MD, Faculty Director, MRCT Center
Sarah White, MPH, Executive Director, MRCT Center