Clinical Trials are Crucial to New Treatments and Cures
As a clinician-researcher involved in cognitive impairment, dementia and Alzheimer's disease, Suzanne Craft, PhD, is keenly aware of the need to recruit patients into studies that help advance those treatments.
She is just as keenly aware of the need to be objective in the recruiting of patients-and their families-so they understand clinical studies may not offer cures.
Participants, both people who are sick and who are healthy, are a crucial need for researchers nationwide, in particular the world of academic medical centers. Wake Forest Baptist Health, for example, currently lists about 350 clinical trials and studies actively seeking volunteers on its website, www.WakeHealth.edu/BeInvolved.
Craft, an internationally renowned expert on aging and dementia, joined Wake Forest Baptist Medical Center last October as research director of the J. Paul Sticht Center on Aging. She also is co-director of the Roena B. Kulynych Center for Memory and Cognition Research.
Participation will be key to a $7.9 million, National Institutes of Health study in which 30 centers nationwide, including Wake Forest Baptist Health, test a new intranasal insulin to see if it improves cognitive impairment or mild Alzheimer's dementia. Craft is principal investigator behind the study.
"Academic medical centers play an integral role in developing new treatments and cures,'' Craft says. "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."
Finding Healthy Study Participants
Clinical trials and studies most often need patients to take medications or to provide data. But many trials and studies also may require healthy participants. Getting people for those can be a challenge.
Kenneth Getz, founder and board chairman of the Boston-based Center for Information on Clinical Research Participation, says factors that can hinder participation are stringent protocols by government and the time required.
Although people who are sick are not often scared off by requirements such as time or testing, healthy subjects sometimes back away once they learn what is being requested.
Getz says healthy people get involved in research for two main reasons: they're either "kind of paying it forward…assisting in advancing public knowledge and medical health'' or the study provides "some type of compensation.''
Rachael Fleurence, PhD, senior scientist at the Patient-Centered Outcomes Research Institute (PCORI) in Washington, says one issue her government-funded agency is pushing is for researchers to work with patients. The idea, she says, is to get patients involved in how to design studies and in disseminating results.
PCORI looks at how to improve existing and approved interventions to improve public health. Although it is difficult sometimes to find participants for clinical trials and studies, the growing use of electronic medical records holds promise for answering research questions, Fleurence says.
With such database driven research, patients' anonymity is protected. All that's required is the time of researchers to pursue and answer questions based on accurate data.
Sense of Fulfillment
People who participate in clinical trials and studies typically enjoy the experience, for a variety of reasons.
Melrose Stocks of Winston-Salem has been involved at Wake Forest Baptist in a long-running study of risk factors for heart disease. She says she decided to volunteer after reading that many studies had been done with only male subjects and should have had female participants.
"I do it and I'm happy to do it,'' Stocks says. "I guess in some miniscule way I'm helping.''
Nancy Riggins, 71, survived a heart attack and breast cancer, and when she was being treated for high blood pressure at the Downtown Health Plaza, was asked if she wanted to join the SPRINT study, which is intended to reduce the systolic level of blood pressure with aggressive medical treatment.
Riggins says in addition to receiving free medications that have, in fact, reduced her blood pressure, she enjoys meeting with the program's nurses and dietitians. She's eating foods she hasn't in the past, such as pomegranates and kiwis, and roasting her chicken rather than frying it.
"A person would be crazy not to join it,'' Riggins says. "I feel a thousand times better.''
Another SPRINT participant, Curtis Minor of Winston-Salem, says the fact that his caregivers are so concerned about his blood pressure "makes you more inclined to be on top of it yourself.''
For pancreatic cancer patient Teresa Thorn, a clinical trial vaccine is something that could help extend her life. She is receiving monthly doses of the vaccine with her chemotherapy after surgery, which allows her not to have radiation. She said volunteering was a no-brainer.
"It just seemed like a good opportunity for them to open more doors, so they would have more knowledge,'' she says.
Barbara Greenberg of Grassy Creek says she had to overcome fear to volunteer for a trial drug program to treat her varicose veins.
"There's always the fear of 'What if something goes wrong?'" she says. Ultimately, she realized that her physician, John Regan, MD, was teaching the use of the drug at other hospitals, which gave her confidence to go through with the procedure, which was successful.
Diverse Participation Crucial
Craft says that one thing researchers have learned over the years is how results can be driven by differences in race, ethnicity and gender. Medical, environmental or other factors can exacerbate those differences.
"For a long time, cardiovascular research was tilted toward men, which led to assessment and treatment for women that wasn't optimal,'' Craft says. The same can be true for minorities, which means that encouraging participation in clinical trials by minorities 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 won't get any argument on that from Ronny Bell, PhD, co-director of the Maya Angelou Center for Health Equity at Wake Forest Baptist. Among the center's objectives are conducting translational research to improve health and developing sustainable and mutually beneficial community partnerships toward that end.
"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,'' Bell says. "Health professionals also need to be well-informed about the health issues that communities are most concerned about, and be actively engaged with communities in creating effective health promotion strategies.''
Ultimately, clinical trial participation is about giving back.
"One of the most important ways you can contribute directly to science is volunteering to participate in studies,'' says Christina Hugenschmidt, PhD, whose specialty is in gerontology and geriatric medicine at Wake Forest Baptist Health. "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.''
Learn More About Clinical Trials and Studies
www.wakehealth.edu/BeInvolved is the website that lists Wake Forest Baptist Medical Center's ongoing clinical studies and allows the public to register for notification of appropriate studies.
www.ClinicalTrials.gov is a service of the National Institutes of Health that serves as a registry and database of publicly and privately supported clinical studies of human participants conducted around the world. It also offers information about the history of clinical studies and relevant policies and laws.