Letter of Intent: October 1, 2012
Full application, if invited: February 1, 2013
The SVS® Foundation announces a funding opportunity directed to Society for Vascular Surgery® (SVS) members developing grant applications for high-impact multicenter clinical studies in the treatment and/or prevention of vascular diseases.
The SVS Foundation Multicenter Clinical Studies Planning Grant is one component of a broad strategy to facilitate clinical research directed at solving high-impact questions in the care of patients with vascular diseases. SVS recognizes that members face significant gaps in knowledge in their day to day care of patients with vascular disease and acknowledges the challenge of designing and executing clinical studies of a scope necessary to provide concrete clinical guidance. Prospective multi-center studies are particularly challenging; yet these studies may be the only practical approach to recruit patient numbers and concomitantly achieve statistical power within a relevant time frame. A major hurdle for investigators planning such studies are the costs of developing compelling preliminary data, recruiting and training collaborators, and creating supporting tools necessary to write a competitive application.
The purpose of the Planning Grant is to help investigators create competitive applications for external funding (e.g. NIH) of full-scale multicenter clinical studies. Funding is intended to support the development of key preliminary data and study resources. The Planning Grant will be broadly modeled after R34 awards from the National Institutes of Health (NHLBI Clinical Trial Pilot Studies
and NIH Clinical Trial Planning Grant Program
). These programs permit early peer review of the rationale and design of a proposed Phase III or IV clinical trial and support development of a research team, assessment tools, and oversight necessary for a competitive application. The NHLBI program specifically focuses on support for pilot studies to obtain critical preliminary data important for the design of a trial that might include: defining the appropriate study population and feasibility of recruitment; demonstrating the feasibility of an intervention or an outcome measure; estimating sample size, effect size, attrition or response rates; or developing and piloting survey instruments. Funds might also be used to prepare an investigator’s brochure or procedure manual or to recruit and train collaborating centers and trial oversight. High impact proposals for multi-center research more broadly-defined than traditional clinical trials (e.g. comparative effectiveness research and prospective database mining) will also be considered.
The Planning Grant specifically targets SVS member investigators with a track-record of productive clinical research. Only applications addressing “high impact” areas in the management of patients with vascular disease will be considered responsive: SVS Clinical Research Priorities
- Further investigate the optimal management of asymptomatic carotid stenosis
- Compare effectiveness of medical versus invasive therapy (open or endovascular) for claudication
- Compare effectiveness of initial open versus endovascular infra-inguinal revascularization for critical limb ischemia
- Develop and compare effectiveness of clinical strategies to reduce cardiovascular and other perioperative complications (e.g. wound) following vascular intervention
- Determine the effectiveness of strategies to enhance arteriovenous fistula maturation and durability
- Develop best practices for management of chronic venous ulcer
- further investigate the optimal adjunctive medical therapy to enhance the success of lower extremity intervention
- Identify and evaluate medical therapy to prevent abdominal aortic aneurysm growth
- Evaluate ultrasound versus computed tomography angiography surveillance post- endovascular aneurysm repair
The planned full-scale trial must be described in sufficient detail to establish its significance and potential clinical impact and to define the need for this award. The period of funding will be for no more than one year and is expected to lead to a mature full-scale application for external funding within six months of completion of the Planning Grant or the first possible grant cycle from the targeted funding agency, if more than six months later.
- PI must hold an MD or equivalent degree with postgraduate clinical training in vascular surgery
- PI must be an SVS Active Member
- PI must have demonstrated experience in conduct of clinical research
- The application must be an “investigator-initiated” clinical study targeting an external funding mechanism compatible with the scope of the research proposed (e.g. NIH)
- Individuals with extramural research support are eligible, provided the projects do not have significant scientific or budgetary overlap
A two-page Letter of Intent will be reviewed and scored based on the impact and importance of the clinical question being addressed; the experimental design of the clinical study including biostatistical strategy and support; maturity of the protocol (how well-developed); environment and experience of the Principal Investigator and team of proposed collaborators; appropriateness of the targeted funding agency for the full scale application; and feasibility of successfully accomplishing the proposed Planning Grant within the period of support. Letters of Intent will be reviewed by members of the SVS Research Council. If deemed competitive, applicants will be invited to submit a full application.
Full applications (if invited) will be reviewed by an ad hoc panel selected by the Research Council with the goal of tailoring expertise to specific proposals. Full applications must demonstrate that the proposed preliminary studies or preparations are both necessary and sufficient to permit the design of the proposed clinical study. Applicants should describe the full-scale study in enough detail to establish its rationale, significance and need, potential impact on health care, policy or practice and thereby provide context for proposed Planning Grant activities. Enough information should be included for reviewers to evaluate how the trial would be conducted. Specifically, provide demographics for the proposed study patient population and address availability and plans for recruitment, outreach, follow-up and challenges to adherence to the proposed protocol. Define statistical methods including issues of power and sample size. A Budget should be included for a period of up to one year and up to US$100,000 direct costs only.
- Letter of Intent (two pages) and biosketch (NIH format) will be required from applicants by October 1, 2012
- Applicants receiving a favorable review of their Letter of Intent will be invited to submit a full application by February 1, 2013.
Applications may be revised and resubmitted in a subsequent grant cycle but must include a one-page introduction summarizing specific changes made in response to the previous critique. Revised grants will be judged on their own merits and against other submissions that cycle.
Financial Support and Award Period
Awards will be for up to US$100,000 (direct costs only) for a period up to one year.
Applicants will be notified of the results of the review process electronically on or before April 1, 2013. The award period for successful applications will begin on this date, pending institutional approvals (e.g. IRB) and adjustments for budgetary overlap for contemporaneous funding to the grantee.
Renewals will not be allowed. Requests for no-cost extensions will be decided on a case by case basis.
A brief progress report is due six months after receiving funding. Rather than a final progress report, completion of the Planning Grant is expected to culminate in a mature full-scale application submitted for external funding within six months, or on the first grant cycle for the targeted funding agency, if beyond six months.
For questions regarding eligibility requirements and the application process, email Sarah Murphy
; phone 800-258-7188; fax 312-334-2320Updated June 2012