Clinical research at Gundersen Lutheran vital to FDA approval process
For several years, Gundersen Lutheran has joined with other major medical centers to conduct research trials essential in determining the safety and effectiveness of new medicines and technologies. Many Gundersen Lutheran departments have participated in these trials—among them Cardiology, Endocrinology, Family Practice, Internal Medicine, Neurology, Pediatrics, Pulmonary, Rheumatology and Urology.
Before a study begins, Gundersen Lutheran’s Research and Human Subjects committees review the protocol to ensure sound scientific and ethical design. Once a study has been approved, certified clinical research coordinators (CCRC) who are also registered nurses carefully explain to patients the details, risks and benefits of participation. Then CCRCs work with participating departments to secure informed consent from patients, coordinate a specific plan of care for each patient, collect necessary data and communicate with the sponsoring company, all while making certain federal research guidelines are observed.
The Clinical Research department is self-supporting. All or most clinical trial-related costs such as clinic visits, laboratory tests, study drugs or devices, and patient stipends for time and travel expenses are paid for with funds provided by the sponsoring pharmaceutical or medical device companies.
All patient participation in clinical trials is voluntary. Some patients volunteer hoping to benefit from a promising new medication or treatment that is not yet approved by the Food and Drug Administration. Most patients also are motivated by a desire to help others by providing information that could increase understanding and lead to better treatments.
The experienced clinical research staff, along with Gundersen Lutheran’s stable, committed and reliable patient population drawn from the Tri-state Region, are two reasons that many pharmaceutical companies choose to conduct their clinical trials at our organization.