Clinical trial NCT00662402: Impact of Extensive Consultation on Career Development Grant Outcomes
Official title: Impact of Extensive Consultation on Career Development Grant Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Career Development Grant Outcomes
Keywords: 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.
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-04-21
Enrollment: 132
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 30 Months
Secondary outcomes:
measure: Percentage of subjects who obtain funding for the submitted proposal
timeFrame: 30 Months
measure: Institute-specific percentile of the priority score
timeFrame: 30 Months
measure: Percentage of subjects who submit proposals for funding
timeFrame: 30 Months
measure: Percentage of subjects who received a good score (<40 or <200) which may be associated with future funding of a resubmission
timeFrame: 30 Months
measure: Percentage of subjects who obtained any career development award funding
timeFrame: 30 Months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Alka Kanaya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Peter Bacchetti, PhD
role: STUDY_DIRECTOR
affiliation: University of California, San Francisco
name: Clay Johnston, MD, PhD
role: STUDY_DIRECTOR
References: