- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
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San Francisco, California, Förenta staterna, 94144
- University of California, San Francisco
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 1-Extensive Consultations
Intervention- Receives extensive consulting services
|
receives 15 free hours of multidisciplinary consultations towards the preparation of their career development grant.
Andra namn:
|
Inget ingripande: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
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)
Tidsram: 30 Months
|
30 Months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Percentage of subjects who obtain funding for the submitted proposal
Tidsram: 30 Months
|
30 Months
|
Institute-specific percentile of the priority score
Tidsram: 30 Months
|
30 Months
|
Percentage of subjects who submit proposals for funding
Tidsram: 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
Tidsram: 30 Months
|
30 Months
|
Percentage of subjects who obtained any career development award funding
Tidsram: 30 Months
|
30 Months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Alka Kanaya, MD, University of California, San Francisco
- Studierektor: Peter Bacchetti, PhD, University of California, San Francisco
- Studierektor: Clay Johnston, MD, PhD, University of California, San Francisco
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
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