- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00662402
Impact of Extensive Consultation on Career Development Grant Outcomes
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
-
San Francisco, California, Forenede Stater, 94144
- University of California, San Francisco
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1-Extensive Consultations
Intervention- Receives extensive consulting services
|
receives 15 free hours of multidisciplinary consultations towards the preparation of their career development grant.
Andre navne:
|
|
Ingen indgriben: 2-Regular levels of service
Control - Receives regular levels of service; one hour free services from each of the 4 units, with option to pay for more.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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)
Tidsramme: 30 Months
|
30 Months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of subjects who obtain funding for the submitted proposal
Tidsramme: 30 Months
|
30 Months
|
|
Institute-specific percentile of the priority score
Tidsramme: 30 Months
|
30 Months
|
|
Percentage of subjects who submit proposals for funding
Tidsramme: 30 Months
|
30 Months
|
|
Percentage of subjects who received a good score (<40 or <200) which may be associated with future funding of a resubmission
Tidsramme: 30 Months
|
30 Months
|
|
Percentage of subjects who obtained any career development award funding
Tidsramme: 30 Months
|
30 Months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Alka Kanaya, MD, University of California, San Francisco
- Studieleder: Peter Bacchetti, PhD, University of California, San Francisco
- Studieleder: Clay Johnston, MD, PhD, University of California, San Francisco
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- K-Trial
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