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Relationship and Trust -
Key for Clinical Research Participants
Patient panelists report positive results from treatment during clinical studies
Bob Pruett was so desperate, he would have signed a "pact with Satan." Instead he participated in a carotid artery study for high-risk patients.
A year and a half later, he was one of four panelists discussing such questions as: What is it like to participate in a clinical research trial? Do patients really understand all of those consent forms they sign? Do they have an unrealistic expectation that they will be cured?
These are the types of questions that weigh upon the minds of clinical research physicians and nurses. Who better to ask than those who have actually participated?
Bob Pruett
Juan Ibanez
Shannon Abert
Crystal Selensky
Getting the answers in an effort to improve clinical research was the idea behind "In Their Own Words - A Panel Discussion with Research Subjects." The Jan. 11 discussion was sponsored by the Association of Clinical Research Nurses and moderated by Eugene Boisaubin, M.D., professor of internal medicine and ethicist for The University of Texas Health Science Center at Houston's University Clinical Research Center (UCRC) at Memorial Hermann Hospital.
Panelists shared their stories and left the audience with a better understanding of their motivations and feelings about clinical research. Whether they perceived they received extra special care, or were participating because they had nowhere else to turn, all of the panelists had positive results to report from their participation in clinical trials.
"I had four neurosurgeons turn me away because I was too high risk to operate on," Pruett said. "I found out about the study to put the stents in, and it has given me a second chance at life - I was completely without hope and didn't feel like I could go on anymore."
Pruett had stents put in one carotid artery, which was 70 percent blocked, and then two months later had the other one done, which was 50 percent blocked.
"I'm not the same man I was 18 months ago - I was overweight and depressed. This program has saved my life, and I'm so thankful for Dr. Smalling and his staff and Memorial Hermann Hospital," he said. Richard Smalling, M.D., Ph.D., is the Jay Brent Sterling Professor in Cardiovascular Medicine and director of the Division of Cardiology in the Department of Internal Medicine at the Medical School.
Juan Ibanez had a heart attack April 29 and was approached the next day about participating in an acute cardiac trial. "I saw it as an opportunity for extra care, not as a guinea pig. I was monitored closely, and it made me feel very secure. The doctors took care of me quite well, and there was no information lacking," he said.
Ibanez acknowledged that the patient consent forms that must be signed to participate in the trial were "a bunch of gobbledygook," but that he signed them anyway because he trusted the words of his nurse, Lynette Westbrook, and the principal investigator, H. V. "Skip"Anderson, M.D., professor of internal medicine at the UT Medical School at Houston.
Scleroderma patient Shannon Abert has participated in two clinical research studies and said she is interested in participating in more. She has become an advocate not only for scleroderma patients, but also for clinical research as a result of her study participation.
"I was so excited about getting into the first study, and my friends were excited that there was someone who could help me. There is just so little known about scleroderma that I want to be right there on top as the technology changes," she said.
Abert said signing the consent forms did not trouble her. "Everything I do, from being here talking to you to doing a radio show requires me signing a consent form. I wish a consent form could just follow my Social Security number," she laughed.
Abert added that when one of the study medications she was taking seemed to make her scleroderma worse, she learned that the primary investigator, Maureen Mayes, M.D., was more interested in her as a patient than as a research subject.
"The disease was progressing rapidly, so Dr. Mayes took me off of the study medication and put me on something she knew would work, which boosted my confidence that she was concerned about my health," she said. Mayes is professor of medicine in the Division of Rheumatology and Clinical Immunogenetics and director of the National Scleroderma Family Registry and DNA Repository.
Panelist Crystal Selensky's 7-year-old son was a patient in a Ewing's sarcoma trial, which required him to go to weekly visits at the UCRC for almost a year.
"It was hard dealing with a kid who had to get poked with a needle every single Monday, and he didn't like it when he didn't have his regular nurse," Selensky said.
In all, the patients said that the relationship and trust they had in the study physicians and nurses was the most important aspect of participating in the clinical trial. The risks had to be well explained by the health care providers, the panelists agreed.
"Over and over again we heard it is that human connection that keeps people participating in and understanding clinical research," said Madelene Ottosen, UCRC nurse manager. "As clinical research nurses, it's important for us to remember that."
This panel discussion was the first of an 11-seminar Research Ethics Series coordinated by the Association of Clinical Research Nurses. See http://www.acrn.info for a full listing.
By Darla Brown, Medical School