Avacen Medical Supports Simplifying NIH Clinical Trial Reports

Avacen Medical Supports Simplifying NIH Clinical Trial Reports
Avacen Medical announced its strong support for a new initiative by the National Institutes of Health (NIH) to expand and enforce its requirement for clinical trial results to be published on ClinicalTrials.gov. The goal of stricter enforcement is to make data from trials more widely available to the public. Avacen's own fibromyalgia clinical trial information can be found on ClinicalTrials.gov (NCT01619579). In a press release, Avacen cites a posting on the U.S. Department of Health & Human Services website quoting NIH Director Dr. Francis S. Collins, MD, PhD, who wrote: "Access to more information about clinical trials is good for patients, the public and science. The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants, who do so much to help society advance knowledge and improve health." According to Avacen Medical CEO Thomas Muehlbauer said he's been disappointed for a long time that most prestigious research institutions "have blatantly violated a federal law requiring public reporting of clinical study results." "Not reporting study results can deny patients and doctors access to important data to help evaluate the safety and potential benefits of new treatments," Muehlbauer said. "After completing our fibromyalgia study, I found that posting the trial results on ClinicalTrials.gov to be a time consuming and arduous process. And, if our results were not so encouraging, I most likely would have considered avoiding the reporting process. Hopefully this process can be simplified to increase reporting compliance." The objective of the Phase 2 Avacen clinical trial, "Investigation of AVACEN Thermal Exchange
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