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Center for Clinical Research holds monthly sessions for clinical coordinators |
| By
Jim Winkler |
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Aug 14, 2006 |
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University Medical Center physicians annually conduct dozens of clinical studies involving human subjects to test the safety and efficacy of new drugs, devices and procedures.
Those trials are conducted by physicians and clinical research coordinators, who may be trained as a nurse or a physician’s assistant or be someone else with a science background.
Now the Center for Clinical Research on the Health Science Campus has launched a monthly series of educational meetings for approximately 25 clinical research coordinators who want to increase their knowledge regarding good clinical practices and current methods for performing high-quality clinical trials.
On the third Wednesday of every month, the center is holding hour-long interactive meetings starting at noon for coordinators to discuss good clinical practice guidelines and tools they need to perform their jobs. The meetings are held in Center for Creative Education Room 0111. Certification review classes are being held for pre-registered clinical research coordinators.
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| Puczynski |
“The educational series is aimed at improving the coordinators’ clinical trial practice across the spectrum,” said Dr. Sandra Puczynski, associate professor of family medicine and director of the Center for Clinical Research.
Clinical research coordinators perform a myriad of tasks. They recruit patients, talk to them about studies, get informed consent, arrange for screenings, administer study medicines, and see patients on their follow-up visits. They make sure the process conforms to rules and regulations and are the contact people when patients have medical problems, reporting it to investigators. They generally have extensive patient-care experience and work with all types of patients, helping them make informed decisions about participating in a trial.
“One way to standardize practice is to have coordinators certified,” Puczynski said, referring to the certification program of the Association of Clinical Research Professionals, which represents more than 14,500 professionals who conduct clinical trials of experimental drugs, biotech medicines and new medical devices. She added that she hopes that eventually every University clinical coordinator gains certification.
New medical treatments and devices undergo various stages of human trials and then are reviewed for safety and effectiveness by the U.S. Food & Drug Administration. In recent years, there has been an explosion in the number of drugs and medical devices, all of which need to be tested before they can be prescribed or sold. Without human subjects, clinical researchers cannot test new therapies that are desperately needed.
A 10-member committee of clinical trial coordinators is working on the series. Committee members are Wendy Boone, Sara Lyons, Pat Kwiatkowski, Andrea Korsnack, Laura Elliot, Kathy Davis, Julia Spears, John Blust, Mary Ann Ankenbrandt and Tamara Hornyak.
A two-day training program on good clinical practice for the coordinators is planned for Tuesday and Wednesday, Oct. 3 and 4. In November, the Center for Clinical Research plans to sponsor a weeklong program on the importance of clinical research and what it means to the Health Science Campus, patients and the public. Among other things, there will be posters displayed in the Skyview Food Court Lobby.
More information about the programs can be obtained by calling 419.383.6919.
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