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APHA Scientific Session and Event Listing |
Anne M. Doherty-Gilman, MPH1, Elizabeth Dean-Clower, MD, MPH1, Weidong Lu, MB, MPH, LicAc1, Ramel Rones2, and David S. Rosenthal, MD1. (1) Leonard P. Zakim Center for Integrative Therapies, Dana-Farber Cancer Institute, 44 Binney Street, Boston, MA 02115, 617-632-3000, Anne_Doherty@dfci.harvard.edu, (2) R&R Mind-Body Therapies, 283 Stratford St., West Roxbury, MA 02132
Background: The establishment of the Office for Alternative Medicine and later the National Center for Complementary and Alternative Medicine helped to fund CAM research studies in hospitals and public health settings. Many studies have had trouble being initiated after funding was secured, yet others have not had problems.
Objectives: Review and describe factors of implementation of five CAM clinical research studies at a cancer hospital. Analyze data based on barriers and facilitators to implementation and discuss the policy and political aspects.
Methods: A retrospective review of data and implementation procedures from five CAM studies in a cancer hospital were evaluated. Recruitment goals and final enrollment figures were reviewed. Demographic, diagnosis, and treatment data were analyzed. IRB correspondence and length of time to activation were examined.
Results: Of the five studies reviewed, one study met recruitment goal, two recruited more than half of goal, one met goal. Some barriers to implementation were multiple IRBs, research space, not having policies inclusive of CAM therapies, and not having credentialing procedures for CAM providers. Facilitators included having strong MD leadership on study team, detailed and realistic planning, and integrating into a CAM clinic.
Conclusions: We identified several barriers and facilitators to implementation of CAM studies. Having open discussions with IRBs and sponsors before the IRB application is submitted can expedite the activation and amendment process. Implementation of future integrative clinical research studies can be more successful if adequately planned for with consideration of the identified barriers and facilitators before the grant application is submitted.
Learning Objectives:
Keywords: Cancer,
Presenting author's disclosure statement:
Any relevant financial relationships? No
Any institutionally-contracted trials related to this submission?
I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.
The 135th APHA Annual Meeting & Exposition (November 3-7, 2007) of APHA