Transcription
Johns Hopkins ClinicalResearch Network (JHCRN)A Collaborative Approach to Clinical ResearchCharles M. Balch, MDICTR Deputy Director and JHCRN DirectorProfessor of Surgery, Oncology, and DermatologyMay 18, 2010
The Johns Hopkins Clinical Research Network (JHCRN)2What is JHCRN? An organization that conduct collaborative clinicalresearch with investigators practicing at medicalfacilities within JHM, and at AAMC, and GBMC to servepatients of Maryland and the region. It is intended to be complementary to or an extension ofclinical research activities conducted at Johns Hopkinsor other Network sites . Johns Hopkins Clinical Research Network (JHCRN)functions within the Johns Hopkins Institute for Clinicaland Translational Research (ICTR).
The Johns Hopkins Clinical Research Network (JHCRN)3Goals of JHCRN: Increase the number and types of protocols andthe capacity to conduct collaborative clinicalresearch Expand collaborations across a range ofconditions and diseases Provide dedicated research personnel, includinga network coordinator for each community-basedsite, to coordinate JHCRN protocols.
The Johns Hopkins Clinical Research Network (JHCRN)Unique JHCRN Characteristics The Network access to a large anddiverse pool of patients. Johns Hopkins functions as theprime contractor for third- partycontracts. Johns Hopkins acts as the primaryIRB of record. eIRB and CRMS provides ashared, web-based informaticssystem.
The Johns Hopkins Clinical Research Network (JHCRN)Advantages of JHCRN1. Ability to increase the breadth and scale ofclinical research and outcomes-based research2. Increased access to innovative drugs,diagnostics, and devices3. Increased revenue from grants and contracts forclinical research infrastructure4. Education and training of physicians and staff onclinical trials and outcomes research5
The Johns Hopkins Clinical Research Network (JHCRN)6Advantages, cont.5. Broader access to clinicalresearch personnel acrossthe network (NetworkCoordinators, ResearchTraining Educator)6. Broader access to Hopkinsand ICTR core researchservices7. Enhanced environment forresearch collaborations
The Johns Hopkins Clinical Research Network (JHCRN)PROGRESS TO DATE: Wrote initial strategy in ICTR grant (2006) andcreated initial leadership with Dr Balch (as Director)and Suzanne Nelson (as AdministrativeCoordinator)Completed Network contracts between JHU andAnne Arundel Research Institute (2009) and GBMC(2010)Hired Network CoordinatorsInitiated Protocols (6 at present) largely aroundMedical Oncology studiesCreated Governance, Structure, and SOPs7
The Johns Hopkins Clinical Research Network (JHCRN)8PROGRESS TO DATE: Started Educational workshops (with DrCharmaine Cummings) with web-basedaccess to video recordings Begun to expand the Network (reviewing 3major medical centers) Developed Corporate Relations with Abbott,Genentech, Lilly, Amgen, and DiagnosticsPhotonics
The Johns Hopkins Clinical Research Network (JHCRN)JHCRN Staff Director: Charles M. Balch, M.D.Associate Program Directors (JH):— Julie Brahmer, M.D. (Oncology)— Lisa Jacobs, M.D. (Surgery)— Fred Brancati, M.D. (Internal Medicine)Network Coordinators:— Sandra Schaefer, BSN, RN, OCN (AAMC)— Cynthia MacInnis, BS, CCRP (GBMC) Administrative Coordinator: SuzanneNelson, MA Educational Consultant: CharmaineCummings, RN, PhD9
The Johns Hopkins Clinical Research Network (JHCRN)10JHCRN Educational pages/catalog.aspx?catalogId cd1551eb-b3df-4854-a9a9-83d9e7ec6d14 Tips for Incorporating Clinical Trialsinto a Busy Practice Clinical Trials in Community Practice:Funding, Resources and Budget Discussing Clinical Trials with Patientsin the Office: Common Pitfalls and BestPractices Recruitment and Retention of Patients Monitoring and Reporting of AdverseEvents Maintaining Quality Data Collection
The Johns Hopkins Clinical Research Network (JHCRN)11II. The Anne Arundel PerspectiveLeadership: Dr. Joseph Moser, Senior VP Medical AffairsDr. Stanley Watkins, AAHSRI Medical DirectorMargaret Matula, BSN, RN, MGA, AAHSRI DirectorDr. Barry R. Meisenberg, Director, DeCaesaris CancerInstituteCatherine Brady-Copertino, RN, MS, OCN, ExecutiveDirector, DeCaesaris Cancer InstituteSandra Schaefer, BSN, RN, OCN, JHCRN Coordinator
The Johns Hopkins Clinical Research Network (JHCRN)Anne Arundel Overview 300 inpatient beds24,500 annual admissions20,500 annual surgical cases2800 employees, with 845 medical staffAAHS Research Institute 97 active protocols 15 research nurses and staff DeCaesaris Cancer Center 1650 new cancer patients 18 cancer protocols12
The Johns Hopkins Clinical Research Network (JHCRN)13JHCRN Trials at AAHSRI1) MSLT-II: Phase III Multicenter Randomized Trial of SL and CLND vs.SL Alone in Cutaneous Melanoma Patients with Molecular orHistopathologic Evidence of Metastases in the Sentinel Node.2) Phase I/II Partial Breast Irradiation with Various ConcurrentChemotherapy Regimens (PBIC).3) Phase I/2 Study of Afilbercept Administered in Combination withPemetrexed and Cisplatin in Patients with Advanced Carcinoma.4) Early Detection and Predicting Recurrence in NSCL.5)A Multi-Institutional Double-Blind Phase II Study EvaluatingResponse and Surrogate Biomarkers to Carboplatin and nab-Paclitaxel(CP) with or without Vorinostat as Preoperative Chemotherapy inHER2-negative Primary Operable Breast Cancer.
III. The GBMC PerspectiveLeadership: Dr. Gary Cohen, Medical Director, Berman Cancer Institute Dr. Paul Celano, Chief Medical Oncologist, Berman Cancer Institute Dr. James Mersey, Director, Geckle Diabetes and Nutrition Center Dr John R. Saunders, Director, Milton J. Dance Jr. Head & Neck Center Dr. Ronald Tutrone, Chief of Urology Cynthia MacInnis, BS, CCRP, JHCRN Coordinator
The Johns Hopkins Clinical Research Network (JHCRN)Overview of GBMC 310 inpatient beds26,700 annual admissions38,000 annual surgical cases3500 employees, with 1250 medical staffBerman Cancer Institute 2200 new cancer patients 55 number of cancer protocols15
The Johns Hopkins Clinical Research Network (JHCRN) GBMC BERMAN CANCERCENTER2250 analytical cancer cases (2007); breast 550,lung 177, colorectal 184, prostate 231, lymphoma 88 5 hospital based med oncs: 1,800 new consults/yr 26 med onc in-patient beds; ADC 15 Hospital infusion center: 55 – 60 treatments/day 16Radiation Oncology: 3 Linear Acc, IMRT, stereotactic radiosurgery, 80patients/day 50 - 60 active clinical trials; 150 accruals/year Hospice program, 400 pts daily census, 24 bed facility
The Johns Hopkins Clinical Research Network (JHCRN)17FUTURE STRATEGIES Fully integrate clinical research collaborative capacityacross the geographically separate institutions that compriseJohns Hopkins Medicine Add up to five affiliated sites that fulfill the following goals:— Increase capacity of JH investigators to conduct researchstudies that could not be done as well ---or as fast– at asingle institution study— Increase capacity to conduct studies in patientpopulations that do not ordinarily come to JH Hospitals— Increase opportunities to collaborate with qualifiedclinical investigators who practice in an affiliated center
The Johns Hopkins Clinical Research Network (JHCRN)18FUTURE STRATEGIES (Cont.) Add up to five affiliated sites that fulfill the following goals— Are located geographically in sites that do not competewith JH Medicine and the present affiliated institutions— Are located geographically in locations not more than 2hours drive so MDs and staff can participate in face-toface meetings— Have an institutional financial commitment to recruit andsupport physician investigators, including research staff Develop robust training and certification programs for MDsand staff— Workshops and tutorials— Electronic and print reference material
The Johns Hopkins Clinical Research Network (JHCRN)19FUTURE STRATEGIES (Cont.) Develop a robust corporate relations program tofacilitate commercial collaborations with NetworkInvestigators for scientifically interesting and significantresearch studies and that enhance the revenue to supportthe clinical research infrastructure and enterprise— Have a portfolio that comprises a diverse mix of drug,device, and diagnostic studies— Have a portfolio that comprises a spectrum ofdisease focus and specialty focus
The Johns Hopkins Clinical Research Network (JHCRN)20FUTURE STRATEGIES (Cont.) Develop capacity to conduct Comparative Effectiveness,Clinical Outcomes and Health Economics Research— Increase collaborations and involvement with facultyin JHSPH Develop capacity to conduct Nursing researchcollaborative studies Enhance the web-based capacity to conduct clinicalresearch (CRMS, CaTissue etc) Develop a stable cadre of research navigators whofacilitate the start-up of high-quality and fully-fundedclinical trials
The Johns Hopkins Clinical Research Network (JHCRN)LOGISTICAL PRIORITIES 21Complete logistical, staffing and legal arrangements toincorporate investigators and research staff throughoutJohns Hopkins Medicine Assess candidate institutions for new membership ,andincorporate into JHCRN as appropriate Expand disease/specialty programs beyond Oncology— Diabetes— Surgery— Intensive Care/Critical Care— Neurosciences— Cardiothoracic and Vascular— Pediatrics
SUMMARY JHCRN is a new core function of the Institute for Clinicaland Translational Research Plan to have up to 5 affiliate members of the JHCRN Intended to be address clinical research issues across majordiseases (with oncology as a template) Should increase the types of trials conducted throughcollaborations, the rate of patient accrual, and funding levels Still in the formative stages of providing infrastructure andlearning how to collaborate together!
QUESTIONS?
facilities within JHM, and at AAMC, and GBMC to serve patients of Maryland and the region. It is intended to be complementary to or an extension of clinical research activities conducted at Johns Hopkins or other Network sites . .
