Career Development Grant OutcomesNCT00662402
Impact of Extensive Consultation on Career Development Grant Outcomes
A study testing Extensive Consultations in people with Career Development Grant Outcomes, run by University of California, San Francisco at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Career Development Grant Outcomes
- What is being tested?
- Extensive Consultations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94144
About this study
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.
Read the detailed description
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.
- Conditions
- Career Development Grant Outcomes
- Being tested
- Extensive Consultations
- Keywords
- K Grant, Career Advancement, Award, Consultation, Application, K, The NIH priority score of the reviewed proposal., Percent of subjects who obtain funding for proposal., Percent of subjects who submit proposals for funding.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extensive ConsultationsOther
Also called Consultations, Extensive Multi-disciplinary Consultations
receives 15 free hours of multidisciplinary consultations towards the preparation of their career development grant.
| Study group | Role | What they receive |
|---|---|---|
| 1-Extensive Consultations | Experimental | Intervention- Receives extensive consulting services Receives: Other: Extensive Consultations |
| 2-Regular levels of service | No intervention | Control - Receives regular levels of service; one hour free services from each of the 4 units, with option to pay for more. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 Months
Secondary outcomes (5)
Percentage of subjects who obtain funding for the submitted proposal
Measured: 30 Months
Institute-specific percentile of the priority score
Measured: 30 Months
Percentage of subjects who submit proposals for funding
Measured: 30 Months
Percentage of subjects who received a good score (<40 or <200) which may be associated with future funding of a resubmission
Measured: 30 Months
Percentage of subjects who obtained any career development award funding
Measured: 30 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startApr 2008
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Career Development Grant OutcomesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alka Kanaya, MD, Principal investigator, University of California, San FranciscoPeter Bacchetti, PhD, Study director, University of California, San FranciscoClay Johnston, MD, PhD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662402
- Sponsor's protocol ID
- K-Trial
- Status last verified
- Oct 2018
- First submitted
- 17 Apr 2008
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Extensive Consultation on Career Development Grant Outcomes
- ClinicalTrials.gov ID
- NCT00662402
- Acronym / sponsor ID
- K-Trial
- Conditions
- Career Development Grant Outcomes
- Keywords
- K Grant, Career Advancement, Award, Consultation, Application, K, The NIH priority score of the reviewed proposal., Percent of subjects who obtain funding for proposal.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Extensive Consultations | Experimental | Other: Extensive ConsultationsIntervention- Receives extensive consulting services |
| 2-Regular levels of service | No intervention | –Control - Receives regular levels of service; one hour free services from each of the 4 units, with option to pay for more. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extensive ConsultationsAlso: Consultations, Extensive Multi-disciplinary Consultationsreceives 15 free hours of multidisciplinary consultations towards the preparation of their career development grant. | Other | 1-Extensive Consultations |
Primary outcome
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)
Time frame: 30 Months
5 secondary outcomes
Percentage of subjects who obtain funding for the submitted proposal
Time frame: 30 Months
Institute-specific percentile of the priority score
Time frame: 30 Months
Percentage of subjects who submit proposals for funding
Time frame: 30 Months
Percentage of subjects who received a good score (<40 or <200) which may be associated with future funding of a resubmission
Time frame: 30 Months
Percentage of subjects who obtained any career development award funding
Time frame: 30 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alka Kanaya, MD principal investigator
University of California, San Francisco
Peter Bacchetti, PhD study director
University of California, San Francisco
Clay Johnston, MD, PhD study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extensive Consultations in people with Career Development Grant Outcomes, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 30 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.