Pilot and Collaborative Translational and Clinical Studies (PCTCS)

The Delaware Valley Institute for Clinical and Translational Science (DVICTS) will develop processes and systems related to the application of evidence-based medicine across the Delaware Valley community. At the outcome level, the priority will be assessment of the effectiveness of attempts to implement evidence-based treatments and guidelines in the community, and studying local and cultural factors associated with treatment delivery and outcomes. With regard to the intervention process, there will be a focus on local modifications to treatment protocols, with emphasis on fidelity to protocols, evidence of tailoring to local, cultural, and individual needs, and effectiveness of such protocol modifications. Individual and cultural factors will be examined as moderators of treatment effectiveness.

Overview and Objectives: The primary goal of DVICTS is to bring together researchers, practitioners, and policy makers from Thomas Jefferson University (TJU), the Nemours Foundation and specifically the A. I. duPont Hospital for Children (Nemours/AIDHC), Christiana Care Health System (CCHS), and the University of Delaware (UD) to conduct clinical and translational science and research. The overall objectives of the DVICTS are novel and innovative, and will represent new directions for many senior and junior investigators; therefore, plans for fostering and supporting pilot research are key to the success of the DVICTS as a whole. Support is partly in the form of funding, but equally as important in the form of structures that promote and support collaborations that span traditional disciplinary boundaries and the sharing of information as data are collected.

The DVICTS partner institutions bring together strengths in the areas of basic preclinical studies (TJU, UD), randomized clinical trials (TJU, UD, Nemours/AIDHC, CCHS), effectiveness and efficacy trials (TJU, UD, Nemours/AIDHC, CCHS), dissemination research (TJU, UD, Nemours/AIDHC, CCHS), and policy applications (TJU, UD, Nemours/AIDHC). The DVICTS initiative plans to conduct research activities that move from preclinical to practice to policy in an iterative process, with a strong focus on bidirectional feedback. Although an emphasis in translational research is often on the application of basic research to practice, the DVICTS will also emphasize the application of community findings back into basic research. To offer a simple example, preclinical research on animal models of maternal neglect may be used to inform the development of intervention strategies for neglecting mothers in the child welfare system; it will therefore be equally important to have findings regarding maternal neglect in the community feedback to modify the animal models of neglect.

The traditional research model raises several obstacles to the effective implementation of collaborative clinical and translational research. For example, junior faculty may be discouraged from engaging in collaborative work because tenure and promotion decisions have historically emphasized their independent contributions to the research field; faculty in one discipline will commonly use terminology that is difficult for those in other disciplines to understand; and collaborating faculty working at different institutions often have to deal with multiple institutional approvals and with the problems of communicating at a distance. In considering the development of the pilot and collaborative studies initiatives and priorities of the DVICTS, we have assessed these obstacles with great care because of the specific need to integrate the capabilities of 4 separate institutions based in 3 different states (Delaware, Pennsylvania, and Florida). We are proposing an operational and management structure that will facilitate collaborations among researchers and practitioners. Cross-institutional support for specific pilot projects and collaborative endeavors will be particularly critical in developing capacity for clinical and translational research efforts through the DVICTS.

For DVICTS to succeed in developing a successful pilot and collaborative translational and clinical study program, we will need to:
  • Systematically engage researchers and clinicians with relevant expertise and skills in seeking novel approaches to participation in this translational research agenda
  • Recruit a larger, more diverse group of faculty and students, representing a wide range of academic disciplines, into translational research activities
  • Stimulate students and faculty to address questions that would not otherwise have been possible
  • Foster the development of cross-cutting research programs that otherwise would probably not have to come together


Eventually, we expect these translational research initiatives to be sustainable through externally generated grant support, and we have the ambitious goal of having 50% of the funded collaborations supported by external sponsors within 4 years of the initiation of the effort. By building on the established record of collaboration among the DVICTS partner institutions, we will use seed grants to foster new collaborative efforts that take advantage of complementary strengths of researchers of the 4 institutions. We will also work to optimize shared use of core research technologies and facilities at all stages of translational research.

The actual funding of projects is only expected to represent a small part of the impact of the DVICTS pilot and collaborative research initiative. By contrast, the structure and processes used for requesting applications is expected to galvanize researchers to collaborate on multiple projects across the 4 partner institutions. As described below, workshops will be scheduled to describe pilot and collaborative funding opportunities, from the DVICTS CTSA and from the NIH to investigators across institutions and across disciplines, so as to set collaborative research initiatives in motion.

The DVICTS CTSA will fund a select group of innovative, novel, translational research projects directly. Each year, the DVICTS CTSA will fund up to 2 pilot projects, 1 mentor/mentee award, 1 collaboration award, and 1 meeting award. As described below, this support will be assigned to: (a) projects that are in their seminal stages, and (b) projects that are further in their development but that require pilot data to be competitive for external funding.

The DVICTS pilot and collaborative clinical and translational research program has 2 primary objectives:
  • To stimulate translational research efforts through pilot studies funded directly by the DVICTS CTSA.
  • To spawn collaborative translational research efforts among researchers of the 4 DVICTS partner institutions that go well beyond the funded work
In the case of the second of these 2 objectives, we plan to foster the development of specific applications for NIH R21, R01, or P01 grants, as well as applications for funding from discretionary funds (from donors, departments, indirect grant funds, etc).

The process for oversight and implementation of the pilot and collaborative clinical and translational research initiative within the DVICTS will be managed by the Delaware Valley Resources on Pilot and Collaborative Translational and Clinical Studies (DVR-PCTCS), with a membership representing the 4 DVICTS partner institutions. The DVR-PCTCS will have designated resources and institutional backing to support new pilot projects and collaborations, including funding for pilot research projects and to initiate new collaborative activities, and will be responsible for fostering new research collaborations through all stages of the process.

Specifically, the DVR-PCTCS will:

  • Issue requests for application (RFA) for funding
  • Actively recruit investigators/collaborators and develop concepts for new projects and collaborations
  • Develop a searchable, Web-based database of core facilities and research expertise at all the institutions
  • Coordinate the review of proposals and make funding decisions
  • Review all programs quarterly
  • Mentor investigators during the course of these projects
  • Identify barriers to collaboration, and marshal resources and administrative backing to overcome them
  • Facilitate preparation and pre-submission review of proposals to external agencies as appropriate


The DVICTS will accept Pilot Projects, Mentor/mentee Awards, Collaboration Awards and Meeting Awards applications. The applications will be reviewed and selected projects will be awarded by the the Review Committee based on standard review criteria. The The review committee will consist of individuals from each of the 4 institutions. All individuals will have significant experience with T2 or T3 research.