Impact of Extensive Consultation on Career Development Grant Outcomes

Study Overview
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Brief Summary
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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) Consultation Services 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.

Detailed Description
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CTSI Consultation Services 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.

Official Title
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Impact of Extensive Consultation on Career Development Grant Outcomes

Conditions
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Career Development Grant Outcomes

Intervention / Treatment
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* Other: Extensive Consultations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Applying for a Career Development grant from the NIH. Anticipated submission date is 3 or more months in the future Resident, fellow, or junior faculty member at UCSF or a CTSI-affiliated institution. Recognized potential benefit from additional consultation Additional areas that could be improved as judged by the subject and the initial consultant Adequate time to provide consultation before submission date
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1-Extensive Consultations<br>Intervention- Receives extensive consulting services | Other: Extensive Consultations<br>* receives 15 free hours of multidisciplinary consultations towards the preparation of their career development grant.<br>* Other names: Extensive Multi-disciplinary Consultations;|
| No Intervention: 2-Regular levels of service<br>Control - Receives regular levels of service; one hour free services from each of the 4 units, with option to pay for more. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH priority score of the reviewed proposal, with unsubmitted or unscored proposals counted as priority scores that are right-censored at 300 (old system) or 50 (new system) |  | 30 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who obtain funding for the submitted proposal |  | 30 Months | 
| Institute-specific percentile of the priority score |  | 30 Months | 
| Percentage of subjects who submit proposals for funding |  | 30 Months | 
| Percentage of subjects who received a good score (<40 or <200) which may be associated with future funding of a resubmission |  | 30 Months | 
| Percentage of subjects who obtained any career development award funding |  | 30 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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K, K Grant, Career Advancement, Award, Consultation, Application, The NIH priority score of the reviewed proposal., Percent of subjects who obtain funding for proposal., Percent of subjects who submit proposals for funding.