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

TUSCALOOSA, Ala. – 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.

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. “What we’re trying to do here,” Higginbotham said, 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 patient benefits and medical knowledge gained, 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.

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 that 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 many 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.”