- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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California
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San Francisco, California, Vereinigte Staaten, 94144
- University of California, San Francisco
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 1-Extensive Consultations
Intervention- Receives extensive consulting services
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receives 15 free hours of multidisciplinary consultations towards the preparation of their career development grant.
Andere Namen:
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Kein Eingriff: 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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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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)
Zeitfenster: 30 Months
|
30 Months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Percentage of subjects who obtain funding for the submitted proposal
Zeitfenster: 30 Months
|
30 Months
|
|
Institute-specific percentile of the priority score
Zeitfenster: 30 Months
|
30 Months
|
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Percentage of subjects who submit proposals for funding
Zeitfenster: 30 Months
|
30 Months
|
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Percentage of subjects who received a good score (<40 or <200) which may be associated with future funding of a resubmission
Zeitfenster: 30 Months
|
30 Months
|
|
Percentage of subjects who obtained any career development award funding
Zeitfenster: 30 Months
|
30 Months
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Alka Kanaya, MD, University of California, San Francisco
- Studienleiter: Peter Bacchetti, PhD, University of California, San Francisco
- Studienleiter: Clay Johnston, MD, PhD, University of California, San Francisco
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- K-Trial
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