Volunteers, Both Ailing and Healthy, Play Integral Role in Clinical Trials

Article ID: 598933

Released: 6-Feb-2013 5:00 PM EST

Source Newsroom: Wake Forest Baptist Medical Center

Newswise — WINSTON-SALEM, N.C. – As an internationally recognized researcher into aging and dementia, Suzanne Craft is keenly aware of the importance of volunteers in clinical studies.

Craft, a professor of gerontology and geriatric medicine at Wake Forest Baptist Medical Center and research director of its Sticht Center on Aging, is the principal investigator in a National Institutes of Health-funded study into the effectiveness of insulin administered through the nose in treating individuals with mild cognitive impairment or mild Alzheimer’s dementia.

But the $7.9 million, nationwide study involving 30 institutions – one of two projects selected by the NIH to be part of its National Alzheimer’s Plan, which aims to find an effective way to prevent or treat the disease by 2025 – won’t be able to attain its goal without a sufficient number of subjects.

The role played by members of the public – both sick and healthy – is an often-underappreciated aspect of clinical research at academic medical centers and other institutions, even if these studies don’t always produce the desired results.

“Academic medical centers play an integral role in developing new treatments and cures,” said Craft, who joined the Wake Forest Baptist faculty in October after 18 years at the University of Washington in Seattle. “In our environment, your job is to find the truth to the best of your ability and report openly whether your study is a failure or a success. And we often learn as much from failures as successes.”

Most clinical trials require people who have the disease or condition being studied to take medications or provide information. But many studies also require healthy participants, and getting those people to enroll can be a challenge.

Ken Getz, founder and board chair of the Boston-based Center for Information and Study on Clinical Research Participation, said factors such as strict government protocols and the amount of time required by trials can hinder participation by the healthy.

People with the specific ailment being investigated are more likely than healthy individuals to feel that they have a stake in a study’s outcome and are therefore less likely to be put off by its requirements. Getz said healthy people participate in research for two main reasons: because they’re “kind of paying it forward [by] assisting in advancing medical knowledge” or because the study offers some type of compensation.

Craft, who earned her Ph.D. at the University of Texas and completed postdoctoral fellowships at Harvard and Boston University medical schools, said one thing researchers have learned over the years is that study results can be driven by differences in race, ethnicity and gender. Medical, environmental and other factors can exacerbate those differences, she said.

“For a long time, cardiovascular research was tilted toward men, which led to assessment and treatment for women that wasn’t optimal,’’ Craft said. The same can be said regarding minority populations, so Craft believes encouraging minorities to participate in clinical trials is “a special issue worth focusing on.”

“I think the idea that research is equitably focused on both minority and non-minority populations, across gender, is an important one,” she said.

That position is echoed by Ronny Bell, co-director of the Maya Angelou Center for Health Equity at Wake Forest Baptist.

“Participation in research is critical to our understanding of the health disparities that exist in many populations and our ability to develop solutions to alleviate these health burdens,” he said.

Ultimately, clinical-trial participation is about contributing.

“One of the most important ways you can contribute directly to science is by volunteering to participate in studies,” said Christina Hugenschmidt, an instructor in gerontology and geriatric medicine at Wake Forest Baptist. “You don’t usually think about it, but whenever you read about groundbreaking new science in human medicine, it means that hundreds or thousands of people just like you came in and volunteered their time.”


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