- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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California
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San Francisco, California, États-Unis, 94144
- University of California, San Francisco
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 1-Extensive Consultations
Intervention- Receives extensive consulting services
|
receives 15 free hours of multidisciplinary consultations towards the preparation of their career development grant.
Autres noms:
|
Aucune intervention: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
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)
Délai: 30 Months
|
30 Months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Percentage of subjects who obtain funding for the submitted proposal
Délai: 30 Months
|
30 Months
|
Institute-specific percentile of the priority score
Délai: 30 Months
|
30 Months
|
Percentage of subjects who submit proposals for funding
Délai: 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
Délai: 30 Months
|
30 Months
|
Percentage of subjects who obtained any career development award funding
Délai: 30 Months
|
30 Months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Alka Kanaya, MD, University of California, San Francisco
- Directeur d'études: Peter Bacchetti, PhD, University of California, San Francisco
- Directeur d'études: Clay Johnston, MD, PhD, University of California, San Francisco
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- K-Trial
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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