Posted on May 3, 2012  Comments (2)

The largest comprehensive analysis of ClinicalTrials.gov finds that clinical trials are falling short of producing high-quality evidence needed to guide medical decision-making.

The analysis, published today in the Journal of the American Medical Association, found the majority of clinical trials is small, and there are significant differences among methodical approaches, including randomizing, blinding and the use of data monitoring committees.

This is a critical issue as medical studies continue to leave quite a bit to be desired. Even more importantly the failure to systemically study and share evidence of effectiveness once treatments are authorized leaves a great deal to be desired. On top of leaving quite a bit to be desired, the consequences are serious. If we make mistakes for example in how we date fossils it matters but it is unlikely to cause people their lives or health. Failure to adequately manage and analyze health care experiments may very well cost people their health or lives.

“Our analysis raises questions about the best methods for generating evidence, as well as the capacity of the clinical trials enterprise to supply sufficient amounts of high quality evidence to ensure confidence in guideline recommendations,” said Robert Califf, MD, first author of the paper, vice chancellor for clinical research at Duke University Medical Center, and director of the Duke Translational Medicine Institute.

The analysis was conducted by the Clinical Trials Transformation Initiative (CTTI), a public-private partnership founded by the Food and Drug Administration (FDA) and Duke. It extends the usability of the data in ClinicalTrials.gov for research by placing the data through September 27, 2010 into a database structured to facilitate aggregate analysis.

Related: Statistical Errors in Medical Studies – How to Deal with False Research Findings – Medical Study Integrity (or Lack Thereof)

“Since 2007, the Food and Drug Administration Amendment Act has required registration of clinical trials, and the expanded scope and rigor of trial registration policies internationally is producing more complete data from around the world,” stated Deborah Zarin, MD, director, ClinicalTrials.gov, and assistant director for clinical research projects, NLM. “We have amassed over 120,000 registered clinical trials. This rich repository of data has a lot to say about the national and international research portfolio.”

“Analysis of the entire portfolio will enable the many entities in the clinical trials enterprise to examine their practices in comparison with others,” says Califf. “For example, 96% of clinical trials have 1000 participants, or fewer, and 62% have 100, or fewer. While there are many excellent small clinical trials, these studies will not be able to inform patients, doctors, and consumers about the choices they must make to prevent and treat disease.”

An analysis-ready copy of the database is now available at www.ctti-clinicaltrials.org. Specialists from numerous therapeutic areas are now scrutinizing the contents to better understand how the number and characteristics of clinical trials match the perceived needs of the research communities.

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