Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

San Francisco, California 94144


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) 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.


Study summary:

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.


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


Study is Available At:


Original ID:

K-Trial


NCT ID:

NCT00662402


Secondary ID:


Study Acronym:


Brief Title:

Impact of Extensive Consultation on Career Development Grant Outcomes


Official Title:

Impact of Extensive Consultation on Career Development Grant Outcomes


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Francisco


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

132


Enrollment Type:

Actual


Overall Contact Information

Official Name:Alka Kanaya, MD
Principal Investigator
University of California, San Francisco

Study Dates

Start Date:April 2008
Completion Date:July 30, 2018
Completion Type:Actual
Primary Completion Date:July 30, 2018
Primary Completion Type:Actual
Verification Date:October 2018
Last Changed Date:October 9, 2018
First Received Date:April 17, 2008

Study Outcomes

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

Study Interventions

Intervention Type:Other
Name:Extensive Consultations
Description:receives 15 free hours of multidisciplinary consultations towards the preparation of their career development grant.
Arm Name:1-Extensive Consultations
Other Name:Consultations

Study Arms

Study Arm Type:Experimental
Arm Name:1-Extensive Consultations
Description:Intervention- Receives extensive consulting services
Study Arm Type:No Intervention
Arm Name:2-Regular levels of service
Description:Control - Receives regular levels of service; one hour free services from each of the 4 units, with option to pay for more.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Francisco

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.