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| Sponsored by: |
University of California, San Francisco |
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| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00662402 |
Purpose
In this study we wish is to determine whether extensive (up to 15 hours) multidisciplinary consultation in biostatistics, study design, data management, ethics, and writing provided by the UCSF Clinical and Translational Science Institute's (CTSI) Biostatics, Research Ethics And Design BREAD program, improves peer review scores of career development grants compared to usual levels of consultation.
We hypothesize that extensive multidisciplinary consultation will improve peer review scores of career development grants compared to usual levels of consultation.
We hypothesize that extensive multidisciplinary consultation will lead to greater numbers of funded grants when compared to the usual levels of consultation.
| Condition |
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Healthy |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Case-Control Study of the Impact of Extensive Consultation on Career Development Grant Outcomes |
| Estimated Enrollment: | 150 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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1
Case - Receives extensive consulting services
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2
Control - Receives regular BREAD services of one hour free services from each of the 5 units
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BREAD is one of the largest programs within the UCSF CTSI. It was created to improve the quality and efficiency of clinical and translational research through the provision of expert consultation. The program is divided into units that provide access to expert consultants in biostatistics, research design (with consultants representing multiple distinct methodologies and disease interests), data management (including data structure and database design), ethics, and scientific writing. With funding from the NIH, the program is able to offer a free hour of consultation in each of its units (up to 4 hours) but charges for additional services to cover costs.
There have been no studies of research consultation services. Though the benefit may seem self evident, such programs are expensive and distract senior researcher from more creative work. Justifying research consultation is important given the multitude of activities vying for attention and funding.
Observational studies of the impact of research consultation services will always be limited by confounding, particularly confounding by indication since those seeking such services may be more highly motivated and organized. Thus, a randomized trial is warranted.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study population will include applicants for K01, K08, or K23 grants with a need for additional expert consultation after an initial consultation.
Participation in a career development grant writing course will be encouraged but not required. Recruitment will occur through direct marketing to junior faculty and through enrollment in the career development grant writing course. Subject consent, including assurance of provision of the grant priority score after review, will be required before enrollment.
Inclusion Criteria:
Recognized potential benefit from additional consultation
Exclusion Criteria:
Contacts and Locations| Contact: Mary Banach, PhD | (415) 476-2027 | mary.banach@ucsfmedctr.org |
| Contact: David Bui | (415) 502-7893 | david.bui@ucsfmedctr.org |
| United States, California | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94144 | |
| Contact: Mary Banach, PhD 415-476-2027 mary.banach@ucsfmedctr.org | |
| Contact: David Bui (415) 502-7893 david.bui@ucsfmedctr.org | |
| Principal Investigator: Caliborne S Johnston, MD | |
| Sub-Investigator: Peter Bacchetti, PhD | |
| Sub-Investigator: Mark Pletcher, MD, MPH | |
| Sub-Investigator: Michael Kohn, MD, MPP | |
| Sub-Investigator: Bernard Lo, MD | |
| Principal Investigator: | Mark Pletcher, MD, MPH | University of California, San Francisco |
| Study Director: | Peter Bacchetti, PhD | University of California, San Francisco |
| Study Director: | Clay Johnston, MD, PhD | University of California, San Francisco |
| Study Director: | Michael Kohn, MD, MPP | University of California, San Francisco |
| Study Director: | Bernard Lo, MD | University of California, San Francisco |
More Information
| Responsible Party: | University of California, San Francisco ( Mark Pletcher MD, MPH ) |
| Study ID Numbers: | BREAD_01 |
| Study First Received: | April 17, 2008 |
| Last Updated: | March 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00662402 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
K Grant Career Advancement Award Consultation Application |
K The NIH priority score of the reviewed proposal. Percent of subjects who obtain funding for proposal. Percent of subjects who submit proposals for funding. |
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Healthy |
