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Compliance In Focus
Posted by John Lehmann on Mon, May 14, 2012

Are Clinical Trials Providing Too Little Information?

The NY Daily News recently published an article which suggests that our industry is falling short in theNeed More Information realm of clinical trials. The article focuses on a report from the Journal of the American Medical Association that was conducted by the FDA and top leaders at Duke University. The objective, as stated in the abstract, was to “examine fundamental characteristics of interventional clinical trials registered in the ClinicalTrials.gov database.”

A review of more then 96,000 studies dealing with intervention medicine registered on the government website found:

  • 96% of trials had fewer then 1,000 patients, and 62% had 100 or fewer
  • 66% of trials were conducted at one single center
  • 60% had no committee to monitor or review the data

As one of the publishers, Robert Califf, points out that “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.”

These weaknesses may attribute to the “gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations” as the publication states. In fact, the conclusion the study made was that the clinical trials registered in ClinicalTrials.gov are mostly small trials and registering and reporting requirements need to be strengthened in order to have a comprehensive evaluation of US clinical trials.

A great presentation is available that gives background and overview to clinicaltrials.gov. In the presentation, the argument is made that registration and reporting of clinical trials should be done for reasons including:

  • Protect Human Subjects- Allowing access to information to public
  • Research Integrity-  Increases transparency of the research enterprise
  • Evidence-Based Medicine- Facilitates tracking of studies and outcomes

Is our National Database failing to provide enough information to prove the three items listed above? Should further laws be in place, with penalties, to require more use and reporting to clinicaltrials.gov? We are interested to here your thoughts.

Photo Credit: Magnus A.

Topics: National Database, FDA, Clinical Research


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