The Value and Effectiveness of ClinicalTrials.gov

The Value and Effectiveness of ClinicalTrials.gov

02.03.13 | By Matt Bennett

For more than a decade, ClinicalTrials.gov has provided patients, family members, researchers and health care professionals with easy access to a comprehensive database of clinical trials information. It was created as part of the Food and Drug Administration Modernization Act of 1997 (FDAMA), and expanded by Congress 10 years later as part of an initiative to broaden the types of clinical trials listed and establish penalties for those companies failing to register or submit results.

Since its inception, ClinicalTrials.gov has been maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). As of February 2, 2013, the registry lists 139,847 studies with locations in all 50 states and in 182 countries. This number has grown exponentially since 2005.

FDA Analyzes British Medical Journal Report

In January 2012, the British Medical Journal published a report that claimed only 22 percent of these trials had submitted results within one year of completion of the trial. Last November, the U.S. Food & Drug Administration provided a preliminary analysis that found that the vast majority (78%) of trials that met the criteria for required reporting were posted on ClinicalTrials.gov and only a low number appeared to be missing. Separately, 31 percent of trials that the BMJ study included as "missing" were classified by the FDA as not required to be submitted.

According to the FDA analysis, the BMJ study may also have included unapproved products, or instances where an applicant was seeking FDA approval for a fixed-dose combination of two medicines already approved for patient use. The FDA generally considers such fixed-dose combinations to be a new medicine.

Finally, despite timely submission, the National Library of Medicine reviews each filed report for quality standards prior to posting (BMJ did not take this into account). Also, FDA found that some of the non-reported studies were led by individuals or academic institutions, not biopharmaceutical companies.

Our member companies are committed to full participation in ClinicalTrials.gov, as outlined in the PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results. The biopharmaceutical sector supports a comprehensive FDA/NIH analysis to explore possible delays in reporting, whether they occur in the private, academic or government sector. While 21% of trials not reported is significant and the causes of underreporting must be studied and remedied, the BMJ study dramatically overstates the problem and does not reflect the full scale of clinical trial data sharing.

For millions of patients across the globe, clinical trials equate to hope for new, innovative and life-saving treatments. Ensuring that qualified trials are available for public consumption and building upon the progress today's system must be a shared responsibility between industry, academia, government and individual patient communities. However, we should also have a fact-based conversation that ensures that the individual patient remains front and center. Anything that interferes with the ability to bring innovative and life-saving new medicines to patients who need them or lessens their hope warrants careful scrutiny and should likely be set aside.

Read more on the effectiveness of clinical trials here.

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