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Participant and Clinical Interactions Resources (PCIR) This unit focuses on the processes and environments that the Delaware Valley Institute for Clinical and Translational Science (DVICTS) will develop to enhance clinical research within individual DVICTS institutions, and importantly, to build more cross-DVICTS human subjects research. The overarching goal is to ensure that flexible, carefully constructed and monitored resources necessary for patient-oriented research are available to all investigators (at all levels) conducting human clinical research studies, and to provide an environment that encourages and supports participation in patient-oriented clinical and translational research. Through development of a "One-Stop Shopping Center," DVICTS will provide intellectual vision, guidance, and leadership, as well as operational resources to promote and support subject and investigator participation in clinical and translational research. The overall goal of the Participant and Clinical Interactions Resources Key Function is to provide an environment that encourages and supports participation in patient-oriented clinical and translational research. A number of challenges need to be overcome in order for DVR-PCIR to support the specific aims addressed in the DVICTS application. Primary among these challenges will be promoting the integration of clinical research for the participating institutions while maintaining organizational identity. The integration will need to address the current barriers to efficient and effective clinical research that is limiting the translation of basic scientific discovery into proven clinical applications or therapies. The final result of this integration will be the development of new methodologies to translate research discoveries into community health settings, the second aim or mission of the DVICTS. These methodologies will be initiated within each participating institution and offered to community providers. The DVR-PCIR will also provide infrastructure for site management and trial conduct within the DVICTS, the four participating institutions, and the network of clinical sites within the State of Delaware and participating Delaware Valley community practices. In addition, the DVR-PCIR will provide support for site-based research, including resources and training for investigators and research personnel. Thus the DVR-PCIR will create a "virtual home" for clinical and translational researchers, thereby nurturing communication, encouraging collaboration, fostering original ideas, and catalyzing the successful conduct of clinical investigation and translational research. Given the geographically dispersed research venues of Jefferson and Delaware institutions community affiliates, there is a critical need for mechanisms that stimulate multidisciplinary research collaborations, enabling investigators from diverse disciplines and locations to communicate, learn, collaborate, and plan together. Overview and Goals: DVR-PCIR supports research that involves direct and prospective investigator/subject interaction (ie, patient-oriented research) as opposed to other types of research within the scope of the DVICTS CTSA (epidemiology, outcomes research, or gene array analysis) that may not necessarily involve direct interactions with subjects. DVR-PCIR provides the bi-directional highway between T1 and T2 but will also support T3 endeavors within DVICTS. By creating an environment that promotes clinical research within the DVICTS organizations and throughout the state of Delaware and the wider Delaware Valley, the hope is to improve participation in clinical research, including participation from underserved populations. The patient-oriented research to be facilitated by the DVR-PCIR group will include (1) delineation of normal human physiologic processes, (2) pathophysiology and natural history of disease states, and (3) development and evaluation of new therapeutic modalities. The cross-DVICTS integration must address the current barriers to efficient and effective clinical research that limits the translation of basic scientific discovery into proven clinical applications or therapies. The final result of this integration will be the development of new methodologies to translate research discoveries into community health settings. In parallel with the development of the organizational structure for clinical research operations within the DVICTS participating institutions, DVR-PCIR will engage the community and practitioners within Delaware and the Delaware Valley area to develop appropriate research strategies, with the ultimate goal of improving overall healthcare in the region. By enhancing cooperative endeavors between the institutions and moving some research activities in to the community, this will facilitate minority recruitment and allow for more rapid completion of studies. Thus the new model for translational research will not only improve the quality of research, but will optimize subject recruitment, increase collaborative investigator participation, facilitate education of investigators in translational research and, optimize ancillary and financial resources and result in increased accrual to clinical trials resulting in improved healthcare and outcomes. Working with the Delaware Valley Resources for Biomedical Informatics (DVR-BMI) and the Delaware Valley Resources for Regulatory Knowledge and Ethics (DVR-RKE), the DVR-PCIR group will develop novel, web-based, and direct interactional strategies to engage the healthcare providers and the community of the Delaware Valley in the clinical research process. By the development of an improved clinical research infrastructure and by engaging the community in participation, the DVR-PCIR group will support DVICTS in achieving the overall aims and mission. Finally, the DVR-PCIR group will work with the educational cluster to develop programs for Delaware and the greater Delaware Valley community to train the next generation of clinical and translational professionals-the first overarching objective of DVICTS. The educational goal of the DVR-PCIR group will be to ensure a positive clinical research experience by providing the necessary background, education, tools, and resources through seminars and training modules for the investigators. Successful development of this "One-Stop Shopping Center" requires efforts to: 1) educate, recruit, and train translational investigators; assist in recruiting appropriate subjects and facilitating their participation; 2) reduce barriers for investigators to engage in patient-oriented research; and 3) encourage basic scientists to become involved in translating their bench discoveries into bedside applications. To meet the three overall objectives defined for the CTSA, DVICTS has organized DVR-PCIR into three units to enhance clinical and translational research opportunities for faculty at the 4 partner institutions and for patients and providers within the Delaware Valley:
The specific objectives of the DVICTS DVR-PCIR function are as follows:
Innovation: The four DVICTS partner institutions bring a wealth of resources and investigator experience to the application. The challenge for DVICTS and the DVR-PCIR resources is breaking down the intra- and interinstitutional barriers that create inefficiencies and building a unified and efficient clinical and translational research engine that enhances the engagement of the community. A major barrier to initiating research protocols is the need for investigators, especially new investigators, to seek assistance on key support functions that are geographically scattered throughout multiple institutions. We propose that (to facilitate and expedite initiation of studies) the new DVR-PCIR offer "One-Stop Shopping Center" by consolidating resources. Specifically, we propose to provide at each of the DVICTS sites the support personnel needed by an investigator to expedite protocol approval, study initiation, and study management. We propose that within the geographic space of the DVR-PCIR will be shared offices for a pool of research coordinators, supported from in-kind contributions provided by the DVICTS institutions, from which investigators with short-term or pilot studies can obtain assistance, including patient, laboratory, and other resource requirements. The DVR-PCIR staff will work with the DVR-RKE staff to coordinate IRB applications and regulatory documents. There will be direct relations with DVR-BERD to assist in design, analysis, and data management for investigators. With this "one-stop shopping" approach, enhancement and efficiency of study initiation, operations, study completion, and summary accomplishment can occur. Leadership, Operational Structure, and Resources: The overarching goal of the DVR-PCIR function within the DVR-PCIR is to organize and improve the current structure and process for research; develop necessary new structure and processes; and direct these toward the overall aims of the DVICTS. Therefore, the PHSD will establish three units (EPRU, CRU, and CRCU) to meet the specific aims for DVR-PCIR, to ensure that flexible, carefully constructed, and monitored resources necessary for patient-oriented research are available to investigators at all levels who are conducting studies relevant to human health. These units will provide intellectual vision, guidance, and leadership, as well as operational resources to promote and support subject and investigator participation in clinical and translational research. The leadership of each unit will report directly to the leadership of the PHSD, and will be responsive to the recommendations set forth by the DVR-PCIR Steering Committee. By existing within the PHSD, the objective will be to create integrated working groups between BERD Unit, DVR-BMI, DVR-RKE, and the CCER The Delaware Valley Unit for Early Phase Research (DVU-EPR): DVU-EPR will be directed by Dr. W. Kraft, current director of the Thomas Jefferson Clinical Research Phase 1 Unit. Dr. Kraft brings a wealth of experience in developing and managing first-in-man clinical studies. The Phase 1 Unit has over thirty years of experience in the conduct of human clinical trials to support the drug development programs of pharmaceutical and biotechnology partners and university-based, investigator-initiated research. Phase 1 Unit projects encompass human clinical pharmacology, including early phase clinical trials for pharmaceutical and biotechnology partners, investigator-initiated clinical research programs at TJU/TJUH, and basic research in fundamental aspects of clinical pharmacology, pharmacokinetics, and pharmacodynamics. Approximately fifteen Phase 1 adult and pediatric studies are conducted annually, including first-in-human trials and collaborative efforts with university clinical subspecialists in special populations. The Phase 1 Unit has sixteen subject beds, a sample processing laboratory, a dedicated research pharmacy, a state-of-the-art analytical laboratory, and facilities for cardiovascular monitoring. The Laboratory of Investigative Medicine within the Phase 1 Unit is equipped to conduct supportive analytical, biochemical, and pharmacological measurements. The Phase 1 Unit is located immediately adjacent to the pediatric inpatient ward in TJUH, and TJU and Nemours/AIDHC faculty have collaborated in Phase 1 clinical research in pediatric and neonatal populations. Legal and contract issues between Nemours/AIDHC and TJU were smoothly and successfully accomplished. Currently, there are three pediatric studies including use of buprenorphine for the treatment of neonatal abstinence syndrome and use of a novel agent to lower elevated levels of bilirubin in neonates. DVU-EPR will be situated in the location of the current Phase 1 Unit at TJU. DVU-EPR will support translational research projects developed in the DVICTS incubators. Three DVU-EPR co-investigators will be based at the other DVICTS institutions and will support Dr. Kraft in identifying appropriate basic research programs within the four institutions that have matured to the point of being ready for the translational research incubator program. The Translational Research Incubator Program Manager will report to Dr. Kraft. With institutional support, in the second year of the DVICTS CTSA, DVU-EPR will expand to another ten beds at TJUH. Pediatric Phase 1 trials coordinated in the CRU will have patients housed in TJUH pediatric or neonatal wards. Dr. Emmett will serve as a co-investigator, along with Dr. B. Boman from CCHS and an investigator to be named from UD. The DVICTS Clinical Research Units (CRUs): Four CRUs will be established, one at each of the four DVICTS partner institutions, under the supervision of Drs. S. Binder-Macleod (at UD), E. Mitchell (at TJU), J. Ross (at Nemours/AIDHC), and M. Saltzberg (at CCHS). These units, supported from in-kind contributions provided by the DVICTS institutions, will be composed of office space for staff, a small number of exam rooms, appropriate storage space for clinical materials, a locked pharmacy area, and laboratory and freezer space for specimen handling. The DVICTS leadership recognizes that each DVICTS partner institution already has experienced researchers and a successful research infrastructure. The objective is to enhance these assets by creating a more effective and efficient clinical and translational research process. In addition, within the DVICTS organization, CRUs will support new investigators through training and facilitate the necessary support to complete research projects within each institution. In addition to providing traditional site-base clinical research operations, the CRUs will also create a patient navigator position that will be a shared resource among the CRU. This position provides a valuable resource to participating subjects in interfacing with DVICTS and will target improved enrollment and retention, particularly of underserved patient populations. Dr. Mitchell will direct the services of the DVICTS CRU group. Dr. Mitchell brings a wealth of experience in engaging communities to participate in clinical research, and she already chairs a diversity committee that includes TJUH clinicians and staff, community physicians, and patient advocates. The work of this diversity committee will be expanded to interface more broadly with DVICTS. The committee has been meeting regularly since January 2006 and has already achieved a number of milestones, including standardization of data collection across the organization with regard to race and ethnicity, emphasizing the importance of self-reporting; changing TJU IRB policy, which now allows for use of short-form consent for clinical trials for foreign language speaking patients; and development of diversity training, one of the most highly attended TJU programs, with a special focus on investigators, research coordinators, and TJU administration. Additionally, Dr. Mitchell is chairperson of the Diversity and Underserved Committee of the Eastern Cooperative Oncology Group and has lead initiatives resulting in a significant increase in minority accrual. Moreover, Dr. Mitchell's research has demonstrated clinical and molecular features of breast and colorectal cancer processes that impact patient outcomes and survival. Dr. Mitchell was recently selected as chair of the National Cancer Institute Committee on Patient Complexity. The CRU model is based, in part, on the Nemours/AIDHC Clinical Trials Program. Improved efficiency through the centralization of the Clinical Trials Program with regards to budgeting and contract negotiation, and the legal and regulatory review of contracts has resulted in increased clinical trials, totaling 120 currently. To facilitate studies involving human research subjects, Clinical Research Services core helps bring consistency and regulatory compliance to those participating in clinical research. Trained study coordinators assist the investigators with study design, subject recruitment, and database management. This core facilitates interactions with the IRB by working with study PIs on protocol development and consent to ensure that they meet institutional and federal requirements. Under the leadership of G. Stets, Clinical Pharmacology in Delaware has focused on improving and ensuring quality in its services provided to the clinical research community. Quality efforts are directed at optimizing the Clinical Trial Standard Operating Procedures, developing a clinical coordinator peer review process and scheduling a series of meetings with the clinical coordinators working in the clinical specialty departments. The Delaware Valley Unit for Coordination of Clinical Research (DVU-CCR): DVU-CCR will be directed by Dr. Whellan, MD, MHS, current director of the Coordinating Center for Clinical Research (CCCR) at TJU. The TJU CCCR is an academic research organization based within the Department of Medicine at TJU. It is currently staffed by seven staff members. CCCR provides feasibility analysis, investigator selection, regulatory documents review and IRB submissions, training, site management, source document verification and query resolution, and investigator site support. CCCR is currently supporting three multicenter clinical trials in the Delaware Valley. Two are multicenter collaborations with the Duke Clinical Research Institute, the Cleveland Clinic Coordinating Center for Clinical Research (C5), and the Henry Ford Research Coordinating Center. In addition to the established heart failure and cardiovascular disease networks, CCCR is currently developing networks in endocrinology, primary care, rheumatology, and cardiothoracic surgery for upcoming clinical trials. Dr. Whellan is a cardiologist trained at Duke University and the Duke Clinical Research Institute. As the co-PI of the "Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Training" (HF-ACTION) trial, an 82-center study funded by the National Heart, Lung, and Blood Institute, Dr. Whellan designed and oversaw the daily operations of the study. DVU-CCR will establish clinical trial networks within the DVICTS institutions to assist in multicenter clinical trials. In addition to the two established networks mentioned above, the DVU-CCR will also have access to the Jefferson Kimmel Cancer Center Network (JKCCN). JKCCN, established in 1993, is now a 22-member organization working together in cancer care, research, and education. Member institutions are located in Pennsylvania, New York, New Jersey, and Delaware. Members have access to cancer center clinical trials including cooperative group clinical trials, as well as to select industry-sponsored trials. DVU-CCR will also collaborate closely with DVR-BERD and DVR-BMI in developing clinical studies. These groups will provide the critical functions of data management, statistical analysis support, and clinical management software. DVR-BERD is established in part based on the experience of the Christiana Center for Outcomes Research (CCOR). The CCOR at CCHS has significant expertise as a coordinating center for clinical trials. Led by Dr. W. Weintraub, the CCOR includes seven clinicians/epidemiologists and five biostatisticians. As a multidisciplinary research group with expertise in clinical medicine, epidemiology, biostatistics, and informatics, CCOR supports ongoing research programs in cardiovascular medicine, nephrology, endocrinology, pulmonary medicine, women's health, infectious disease, and general internal medicine, both locally and in collaboration with leading outcomes research centers across the country. CCOR has particular expertise in cost-effectiveness and health status assessments in clinical trials. CCOR is a key component of the Biostatistics, Epidemiology, and Research Design Core of DVICTS. The primary responsibility of DVU-CCR will be to coordinate multicenter studies on behalf of DVICTS and to develop clinical research networks within the Delaware Valley by working with providers and community leaders. For clinical studies involving more than one DVICTS CRU and/or one of the DVICTS clinical trial networks, DVU-CCR will work with each enrolling center to organize the study and provide assurance that the study is initiated and executed in a consistent manner among each of the centers. In addition, DVU-CCR will develop centralized resources for DVICTS investigators for business management (pre- and post-award), regulatory compliance, and site management. The primary tool for coordination of clinical studies is the Clinical Trial Management System (CTMS), which will be provided by the CCCR at TJU. CTMS allows the management of centers within specific trials and the benchmarking of sites across the network needed for planning future studies and for retraining of underperforming sites. The Network Development Team (NDT) will be an integral component of the DVU-CCR. The NDT will work with new investigators within the Delaware Valley to establish their practice as a DVICTS clinical research site. This will include assessment of each new site's resources and identification of necessary resources, training of the site investigator and staff, including Good Clinical Practice Guidelines, and provision of assistance to new sites in the implementation of clinical studies. In the first year, the NDT will develop necessary material and initiate training of a primary care network, with a focus on underserved communities in the Delaware Valley. As each network is established, NDT personnel will be placed in charge of the network and will work with DVU-CCR business development to place industry or NIH-sponsored clinical trials within the established network. In order to promote the development of a pediatric clinical trial network, which will utilize the Nemours pediatric practice networks, two pilot studies will be initiated within the practice network. The pilot studies will be prospective registry of two chronic diseases (i.e. asthma and diabetes) that will allow the NDT to work with the practices to establish clinical research operating procedures and experience. This will prepare the network for future pediatric clinical trials. |