Our Work

Advancing the Quality of Clinical Trial Enterprise

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.

Contact us: mrct@bwh.harvard.edu


  • 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

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

Project Resources