The Clinical Research department at Southwestern Medical Clinic has participated in more than 100 clinical trials over the past decade, and is preparing for future growth following its alignment with Lakeland HealthCare.

"We offer physicians throughout the Lakeland system the opportunity to become involved in clinical trials, even if they are unable to devote the staff to clinical research in their own offices," said Richard Hines, MD, Medical Director of Clinical Research for Southwestern Medical Clinic, an affiliate of Lakeland HealthCare. "For physicians, clinical trials are an interesting change of pace from routine patient care, as well as an additional source of revenue in a time of dwindling reimbursements."

Clinical Research staff members are based in Southwestern Medical Clinic’s Bridgman, Niles, and Stevensville offices, and at Lakeland Regional Medical Center, St. Joseph.

ENSURING SAFETYAND EFFECTIVENESS

Most consumers are unaware of the long path a drug travels from the laboratory to their medicine cabinets. To qualify for clinical trials, a pharmaceutical company’s Investigational New Drug Application (IND) is reviewed by the U.S. Food and Drug Administration (FDA) and a local institutional review board (IRB), a panel of scientists and non-scientists in hospitals and research institutions that oversee clinical research. Once approved, clinical trials take place in phases. According to Dr. Hines, Southwestern Medical Clinic usually recruits participants for clinical trials in Phase II or III.

"We tell our patients that the FDA has a rigorous process for ensuring safety and effectiveness of new medications," said Dr. Hines. "In fact, many drugs approved and used in Europe must be tested again in the U.S. before approval. We reassure our participants that they are taking part in a medication trial toward the end of a very long process."

BENEFITS OF CLINICAL RESEARCH

The Clinical Research team at Southwestern Medical Clinic cites a number of reasons that local residents participate in clinical trials, such as access to medications not yet available to the public and cutting-edge care that is often free. Although Clinical Research Coordinator Karen Styf, RN, says that recruiting participants is the greatest challenge in any clinical trial, she has received positive feedback from participants, including many who ask to enroll in future trials. "People are generally very receptive to the idea," Styf said. "Participants tell us they are glad to live in an area where these kinds of opportunities are available."

The benefits of clinical trials are not limited to southwest Michigan. Dr. Hines said that in 2002, Southwestern Medical Clinic pediatricians enrolled nearly 300 local infants in a rotavirus vaccine trial. When the trial ended and data was evaluated, the FDA approved the oral vaccine, which is now part of the routine vaccination series given during the first year of a baby’s life.

"Through the rotavirus vaccine, we can prevent hospitalizations of children and save money here in our community," said Dr. Hines. "In third-world countries, however, the vaccine can help save lives. It’s good to be a part of that, and to see the impact that clinical trials can make."