UNIVERSITY OF ALABAMA AT BIRMINGHAM
Grant: $99,592 - National Institutes of Health - Aug. 17, 2009
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Award Description: CAMUS is an 11 site placebo controlled clinical trial testing the efficacy of saw palmetto in the treatment of benign prostatic hyperplasia. The CAMUS Data Coordinating Center (DCC) provides infrastructure support and is responsible for: 1. Coordinating the development and amendment of the protocol; 2. Designing and distributing Case Report forms; 3. Coordinating executive and steering committee meetings and other study committee meetings; 4. Developing recruitment reports which have proved invaluable in monitoring and encouraging recruitment. 5. Providing other data reports as required by study committees. Recruitment of the 350 participants for this study was originally expected to be completed by December 08; however, due to slow accrual, recruitment was extended until April and finally 370 participants were recruited, which increases the overall participant and data volume. This affects our budget in a number of ways. Further, the Steering Committee decided to distribute home blood pressure monitoring devices to each participant as a way to reduce the visit burden on the participant as well as an incentive to participate in the study, which increased our costs by $23,300. As a result, the DCC has inadequate staff for preparing statistical reports and otherwise monitoring participant retention and follow up; monitoring adverse and serious adverse events and for preparing data reports for the DSMB, the Steering Committee and the Executive Committee. This administrative supplement requests funding the additional new staff needed to ensure timely production of DSMB reports and otherwise preparing for the closeout of the study and data analysis. We propose to hire a new full time MS statistical analyst who will be dedicated to CAMUS and fully funded via this supplement plus a new project assistant at 65% effort, who will then be able to devote a 100% effort to the CAMUS DCC. Both will work under the direction of Dr. Meleth, DCC Deputy Director and Dr. Williams, to whom Dr. Meleth reports
Project Description: CAMUS is an 11 site placebo controlled clinical trial testing the efficacy of saw palmetto in the treatment of benign prostatic hyperplasia. The CAMUS Data Coordinating Center (DCC) provides infrastructure support and is responsible for: 1. Coordinating the development and amendment of the protocol; 2. Designing and distributing Case Report forms; 3. Coordinating executive and steering committee meetings and other study committee meetings; 4. Developing recruitment reports which have proved invaluable in monitoring and encouraging recruitment. 5. Providing other data reports as required by study committees.
Jobs Summary: Not Started (Total jobs reported: 0)
Project Status: Not Started
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