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U.S. Tightens Guidelines For Clinical Trials

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Pharmaceutical companies and universities that recruit participants for clinical trials and surveys now face tougher rules that seek to ensure important information from these participants is made publicly available, not only to the volunteers but also to other scientists, NPR reports.

The current rules are ambiguous and often bypassed. One such stipulation, made in 2007, is that scientists have to post the results of their experiments on a federal website called But many high-profile schools and drug makers have ignored those standards, according to studies and journalists.

Francis Collins, director of the National Institutes of Health, says,

We as a community have had a disappointing track record.

Collins and other health officials expect that to change in the implementation of clearer, more expansive rules, as well as strict penalty clauses as released by the Department of Health and Human Services.

The new guidelines were published in the Federal Register. They were designed to clarify which experiments scientists and corporations must include in the government compilation, and broadens the list of studies that must be registered to include behavioral therapies if they are run by NIH funding.

And for the first time, the rules require all experiment results to be posted, even for drugs that have failed in studies. Researchers must also convey how they will analyze their results, in order to deter scientists from suddenly shifting focus to findings that may appear, but that they were not looking for. This will limit the number of studies with low quality data or results.

Collins calls clinical trials, “the gold standard for understanding the effect and effectiveness of medical interventions, understanding what works and what doesn’t work.” If information from these trials are shared, scientists can potentially identify how to avoid repeating mistakes, cutting down on the waste of funding. As of now, scientists don’t know what methods and processes others use in their work as failures are not reported.

There’s also the question of ethics, as millions of participants join these studies. Collins says it is a social responsibility for scientists to disclose the results to these volunteers.

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