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Experts discuss ways to embed patient voices and values in clinical research
Date:4/30/2013

Rochester, MN, April 30, 2013 There is worldwide concern in the biomedical research community that enrollment in clinical trials is lagging, putting clinical research and consequent benefits to society in jeopardy. Experts explore ways to embed patient voices and values in clinical research in the current issue of Mayo Clinic Proceedings.

Clinical trials of new drugs, devices, or procedures require the active participation of human volunteers. Mark A. Yarborough, PhD, of the Bioethics Program, University of California Davis, calls for greater transparency about the social value of research in recruiting patients to participate in clinical trials, as part of the initial informed consent process.

"Not all clinical research is equal," Dr. Yarborough says, comparing research into the use of stem cells to improve the life of Huntington's disease patients with "me too" drug studies that are competing with existing and effective (and often cheaper) medicines to treat conditions such as hypertension. "Clinical research has produced a lot of good, life-improving and life-saving drugs that have really improved the lot of patients. But we need to remain mindful that some trials are more deserving of public trust than others." He proposes the incorporation of a clear declaration in informed consent forms that states whether a trial is investigating a way to potentially improve current medical care and explains why it does or does not have the potential to do so.

"We owe the public honest disclosure about why any given trial is being conducted so that they understand the extent to which a trial, if completed, could promote the common good," Dr. Yarborough explains. "The informed consent process is one way to provide this disclosure to prospective research participants."

Yarborough acknowledges that there may be critics but, he continues, "One possible good outcome is just to have discussion about transparency about the research
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Contact: Rachael Zaleski
mcpmedia@elsevier.com
215-239-3658
Elsevier Health Sciences
Source:Eurekalert

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