- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94144
- University of California, San Francisco
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 1-Extensive Consultations
Intervention- Receives extensive consulting services
|
receives 15 free hours of multidisciplinary consultations towards the preparation of their career development grant.
Otros nombres:
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Sin intervención: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
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)
Periodo de tiempo: 30 Months
|
30 Months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Percentage of subjects who obtain funding for the submitted proposal
Periodo de tiempo: 30 Months
|
30 Months
|
|
Institute-specific percentile of the priority score
Periodo de tiempo: 30 Months
|
30 Months
|
|
Percentage of subjects who submit proposals for funding
Periodo de tiempo: 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
Periodo de tiempo: 30 Months
|
30 Months
|
|
Percentage of subjects who obtained any career development award funding
Periodo de tiempo: 30 Months
|
30 Months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alka Kanaya, MD, University of California, San Francisco
- Director de estudio: Peter Bacchetti, PhD, University of California, San Francisco
- Director de estudio: Clay Johnston, MD, PhD, University of California, San Francisco
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- K-Trial
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .