A Shifting Approach

Clinical Trials Eyeing Rural America, UA Looks to Expand Its Role

By Chris Bryant

Carleigh Clark, 5, visits with Drs. Elizabeth Cockrum and Karen Burgess at UA's University Medical Center. Cockrum and Burgess are among a growing number of the medical center's physicians involved with clinical trials. (Laura Shill)
Carleigh Clark, 5, visits with Drs. Elizabeth Cockrum and Karen Burgess at UA’s University Medical Center. Cockrum and Burgess are among a growing number of the medical center’s physicians involved with clinical trials. (Laura Shill)

A new version of a nasal spray flu vaccine shows greater effectiveness in preventing influenza in test patients than did an injectable flu vaccine, according to data from the new drug’s latest clinical trial.

That data, released in late 2005, came from a study based on more than 8,000 children in 16 countries, including some three dozen patients enrolled via The University of Alabama’s University Medical Center. Such links between broad-based clinical trials and UA are likely to become more common in the future, according to Dr. John C. Higginbotham, associate dean for research and health policy in UA’s College of Community Health Sciences, a Tuscaloosa-based clinical campus of the UA School of Medicine.

“Clinical trials are an excellent way for new clinical faculty at the School of Medicine here in Tuscalooosa to have exposure to research and research activity,” said Higginbotham, who also directs UA’s Institute for Rural Health Research, which coordinates the clinical trial efforts in Tuscaloosa. It also gives students more research interaction, an objective for all the UA School of Medicine’s campuses, he said.

“We think doing this sort of research also provides cutting edge information for faculty which provides cutting edge information to students and the patients we see here and, ultimately, for the patients our students will see down the road,” Higginbotham said.

Dr. John Higginbotham and Melanie Tucker envision an increasing number of clinical trials heading to UA. (Laura Shill)
Dr. John Higginbotham and Melanie Tucker envision an increasing number of clinical trials heading to UA. (Laura Shill)

Historically, the health care industry has concentrated their clinical trials within large urban areas, where the pool of potential participants is large and where the patients have easy access to their physicians for the sometimes frequent follow-up visits that are required. Those patients have also typically been white and from middle to upper class status, Higginbotham said. With fewer participation opportunities, rural patients are often less familiar with, and sometimes more skeptical of, trials when they are approached, industry leaders say.

“We have found over the last several years that not all medicines act the same in all groups,” Higginbotham said. “What we’re trying to do here is provide an avenue where we can include rural and minority groups in those trials to make sure they have representation.”

A documented shortage of clinical research investigators is causing the industry to re-visit their focus areas. In response, some are turning their research trial efforts to overseas patients and physicians, but others are turning toward rural U.S. markets.

In 2005, UA’s University Medical Center participated in seven clinical trials, said Melanie Tucker, a research associate who, as clinical study coordinator, leads the Institute for Rural Health Research’s clinical trials. In addition to the value health care workers, students and patients receive, hosting clinical trials provides the Institute and the College a source of revenue for additional research, Tucker said.

In the recent MedImmune Inc.-sponsored trial of the nasal spray flu vaccine, patients gained free access to the vaccines. “It was when the flu vaccine was at a premium,” Tucker said. “The children who received the flu vaccine might not have been able to find it, otherwise, and some would not have been able to afford it,” she said. Throughout the duration of the trial, patients who became ill, whether from the flu or another cause, received free exams, tests and access to after-hours care, Tucker said.

Only 3.9 percent of the patients who took MedImmune’s easier-to-store version of FluMist, known, for now, as CAIV-T, came down with the flu, according to the overall Phase III trial results. Of those in the study who took conventional flu shots, 8.6 percent contracted the flu, MedImmune announced. The company says it is seeking FDA approval and hopes to begin selling the new drug beginning in the 2007 flu season.

Trials may be initiated by pharmaceutical companies, the National Institutes of Health or a qualified physician. “More than half of our clinical trials today are investigator initiated,” Tucker said.

University Medical Center, UA’s $13.5 million, 77,000-square-foot, multi-specialty clinic, which opened in May 2004, can only positively impact UA’s efforts to increase the level of clinical trials on site, Tucker says.

Dr. Elizabeth L. Cockrum, a physician and member of the UA College of Community Health Sciences faculty, was principal investigator on the FluMist trial at UA. A UA colleague, Dr. Karen Burgess, was the sub-investigator. Cockrum and Burgess were recently awarded Certified Physician Investigator designation. This certification, by the American Academy of Pharmaceutical Physicians, signifies a physician possesses the capabilities to conduct clinical trials in accordance with the required regulatory standards.

Cockrum, associate dean for clinical affairs at the School of Medicine and professor of pediatrics, said most families are initially hesitant to participate in clinical trials and somewhat apprehensive in using an “experimental drug.” “However, once everything is explained, most view it is an opportunity to contribute to medicine and find it exciting.”

Addressing all the patient’s concerns, giving them ample time to review the information and explaining all risk, procedures and expectations can help patients feel more comfortable in participating, she said. “They should also be assured that they are free at any time to withdraw from the study without any penalty or threat of loss of medical care.”

Clinical trials are significant on many levels, including allowing patients to directly contribute to the knowledge of medicine, Cockrum said.

“As a physician, it is important to keep current of the newest therapies which are being developed, and this is a way to do that. It is also good exposure for our medical students who may decide to make medical research their career.”

Higginbotham says participating in the industry-initiated trials is another step in working toward solving specific health care issues.

“Our experience here will lead to more of our investigator-initiated projects that closely work with the problems that we identify for rural and minority groups and which, hopefully, will help alleviate those disparities that we see.”

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