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Advancing the Quality of Clinical Trial Enterprise

Focus Area: Current Project

Focus Area: Ethics, Conduct, and Oversight

Advancing the Quality of Clinical Trial Enterprise

Clinical trials are a critical component of the medical evidence base.  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.

Examples of trials of concern include not only those conducted long after the study question has been answered by previous studies but also those trials that fail to complete. In addition, there are large numbers of trials that are not incorporated into systematic reviews because of lack of relevance (e.g., use of inappropriate comparators) or high risk of bias (e.g., due to flaws in randomization process).  Requirements for trial registration and results reporting have greatly improved the availability of information about ongoing and completed trials, while simultaneously exposing the issues with incomplete and poor reporting of results.

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.  We intend to take on this challenge.  In addition, we intend to 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.

Current Status: Active

Anticipated Impact:

Improving the design and the quality of clinical trial reporting will result in a reduction in the number of non-informative trials that are initiated. Along with improved trial reporting, the impact will be a higher quality clinical trial evidence base and ultimately the improved use of clinical trial data to inform research decisions.

Approach:

We will conduct a suite of activities aimed at addressing three problems affecting trials conducted at US academic medical centers (AMCs):

  1. poorly designed clinical trials
  2. poorly reported clinical trials
  3. insufficient use of trial data to inform research decisions, such as the initiation of new trials

Currently, the following projects are in varying stages of development:

  1. Improving trial protocols
  2. Developing trial metrics
  3. Increasing use of data from ClinicalTrials.gov to inform research decisions

Project Leadership:

  • 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

Contact information:  mrct@bwh.harvard.edu