Profiles of a Clinical Trials Office

Profiles of a Clinical Trials Office Collette Houston, Memorial Sloan-Kettering Linda Marks, Sutter Health - Sacramento Meaghan Reyes, Hospital for Special Surgery Learning Objectives • Identify necessary elements, staffing resources and activities for a robust clinical trials infrastructure • Learn how to: o define your institutions clinical trials infrastructure needs o establish a comprehensive clinical trials oversight program o identify potential areas of problems, standardize communications and resolve clinical trials issues o evaluate your institutional compliance with all aspects of 45 CFR 46 Overview • Explain why centers are supporting/organizing centralized offices • Provide description of (3) different clinical organizations participating in clinical research • Structure of the organizations clinical research infrastructure • Lessons we‟ve learned through development and implementation of the infrastructure • Communication techniques utilized • Current projects and next steps for the organizations • How do you define your own institution‟s needs Why have a centralized Clinical Trials office? • Research Participant Involvement • Research Coordinator Certification • Journal of Negative Results • Increased federal oversight • Lawsuits • International arena • Increased regulatory oversight of clinical research: Memorial Sloan-Kettering Cancer Center New York, N.Y. Overview of Center • • Located on Upper East Side in NYC Specialists in Cancer • Research Portfolio History of Clinical Trials Office • • Established in 2001; “Office of Clinical Research” Mission Statement: to support the highest quality program in clinical research through central management, standardized practice and oversight to our clinical trials programs. Overview of the Cancer Center • Main Campus • Main hospital, Urgent Care, In-Patient and Out-Patient Services, Zuckerman Research Building • Adult out-patient services (primarily solid tumor), Pre-admission testing, Diagnostic Imaging • Outpatient Pavilion @ 53rd St • Breast Center @ 64th Street • Surgical and Medical Oncology, Diagnostic Imaging • Surgical and Medical Oncology, Diagnostic Imaging for Urologic Ca • Adult out-patient services in medical oncology, surgical oncology and radiation oncology, Diagnostic Imaging • Sidney Kimmel Center @ 68th • Regional Network Sites in Long Island, Westchester and New Jersey Clinical Research Environment • State-of-the-art Outpatient Facilities (OPF) • NYC based OPF‟s are located within 1–15 blocks of the main campus • Regional Network OPF‟s are located between 20-55 miles from the main campus • Operates as a „Paperless‟ Environment: o o o o o o o o Clinical Care Standards Clinical Research Database (CRDB) Electronic Medical Record (EMR) Order Entry/Management System Digitized Radiology (PACS) Intranet-based IRB Protocol Web Application Protocol Information Management System (PIMS) MSK Intranet-based Clinical Research Portal Clinical Research at MSKCC Protocol – Participant Activity over Time 180 160 140 120 100 80 60 40 20 0 2002 2003 2004 2005 2006 16000 15500 15000 14500 14000 13500 13000 12500 12000 11500 New Protocols New Participants Clinical Research at MSKCC Total # of Active* Protocols = 600 Protocol Type Therapeutic Diagnostic Psychosocial Quality of Life # 370 91 33 27 % 61.6% 15.2% 5.5% 4.5% Specimen Banking Genetic Epidemiologic Prevention Other 27 20 17 13 2 4.5% 3.3% 2.8% 2.2% 0.3% * Represents open for accrual at some point during the year [January 1, 2006 – December 31, 2006] Organizational Structure Memorial Hospital Physician-in-Chief Research Council Office of Clinical Research IRB/Privacy Board Education Programs Web Development Research Billing Protocol Development Research Management Data Management Resource Clinical Research QA Manufacturing QA IRB/ Privacy Board Office Clinical and Laboratory Investigators and Research Support Staff OCR Personnel by Division OCR Division Operations/Administration # of Staff 16 Protocol Development Research Management Data Management Clinical Research QA 5 6 11 5 Manufacturing QA IRB/PB Office TOTAL 4 5 52 New Initiatives • Expansion of educational programs and information access o Creation of Clinical Research Web Portal o New program geared towards Junior Faculty o Enhanced and expanded educational opportunities for research staff o Re-design of all research related web-sites • Enhance Research Billing Processes o Expand user functionality of system (ARC) o Standardize budget process for internal and externally sponsored trials o Close financial loop with Research Administration Sutter Institute for Medical Research Sacramento, CA Overview of Center – – Located in Downtown Sacramento, CA Investigator Staff-Private MDs, Foundation Groups, Private Groups – Research Portfolio History of Clinical Trials Office – Founded in 1959 at Sutter Memorial Hospital with research resulting in the Cutter-Smeloff heart valve, SIMR now serves the Sacramento-Sierra Region. – Mission Statement:: To integrate research into clinical care Organizational Structure Chief Medical Officer SHSSR SIMR Medical Director Training Lab SIMR Operations’ Director Dept Secretary Call Center Staff Research Ass’t Contracts, Finance, and Billing Compliance Managers Quality Assurance Specialist Clinical Research Coordinators & Regulatory Technicians Research Support PhD Epidemiologist Research Scientist Data Technicians Sutter Health Sutter Health 30 Healthcare Affiliates (California and Hawaii) Sutter Institute for Medical Research Sutter Sacramento-Sierra Region Sutter Auburn Faith Medical Center Sutter Davis Medical Center Elk Grove (Laguna Family Practice) Sutter Roseville Medical Center Sutter Medical Center, Sacramento Sutter Solano (SRMF) Geographic Scope Solano Fairfield and Vacaville SIMR Centralization Amidst Decentralization Decentralization: • Sutter Health encourages affiliates to keep their own special identities. • Multiple administrative approvals required. • Multiple physician office structures to navigate. • Multiple individual policies embedded in the Health System‟s overall policies. Research Centralization: • Designated Chief Administrator, Medical Director and Administrative Director to represent research. • Centralized research tasks and responsibilities. • Physician Champions (point persons throughout region) SIMR Centralized Office Structure • Administrative – – – – – – Budget/Contract Process Clinical Trials Finances Management Billing Compliance Sponsor Relations Investigator Recruitment Quality Assurance (Study Monitoring and Auditing) • Clinical Trials – Study Management – Patient Recruitment • Centralized Patient Database • Call Center – Database Development (Research Specific) • EPIC Electronic Medical Record • Velos e-Research Database SIMR Research Areas and Study Activity Sutter Institute for Medical Research: General Medicine Trials -45 Investigator Initiated Trials – 10 Sutter Heart Institute: Cardiovascular Trials – 12 Sutter Neuroscience Institute: Inpatient Stroke Trials - 4 SIMR Future Growth SIMR Growth – Increase Principal Investigators – Standardize Contracts • Tract Manager • Master Contracts – Continued Development of Technology – Increase Quality Assurance and Control Sutter Health Growth – Centralized Sutter-wide Research Sites-Sponsor Study Feasibility Process Hospital for Special Surgery New York, NY Overview of Center • • • Located on Upper East Side in NYC Specialists in Orthopedics and Rheumatology Research Portfolio History of Clinical Trials Office • • Established in 2005; “Clinical Research Department” Mission Statement: The Clinical Research Department (CRD) is dedicated to supporting, fostering, and ensuring safe, compliant and scientifically valuable patient-oriented clinical research at HSS. Organizational Structure President and CEO Medical Director, Clinical Research Vice President, Research Administration Director, Clinical Research Department Manager, Manager, Manager, Manager., Trials Facilitation Clinical Research Accounts Clinical Research Monitoring Clinical Research Staff Coordinators (2) PI IRB CRD FDA COI Legal Funding Source Finance Technology New Initiatives • HSS – Evaluating level of ICH compliance • Gap Analysis Projects – Research-related charges • Further developing home-grown application – Clinical and Translational Science Award (CTSA) Summary Year centralized office established ~ Number active (open to accrual) IRB protocols Number of staff in centralized office Internal monitoring division Research related charge component 2001 450 52 Yes Yes 1991 71 5 Yes Yes 2005 322 7 Yes Yes Research staff training component Contracts and budgets component Protocol development component Regulatory oversight component Yes Yes/No Yes Yes Yes/No Yes Yes Yes Yes Yes No Yes Centralized research staff to resource to various studies Central registration to track patient enrollment No Yes Yes No Yes No Clinical Trials Office Infrastructure Senior Leadership Support and Guidance Approved/Written Policies and SOPs Yes In Progress Yes Yes Yes In Progress Regular Communication to Research Community Shared knowledge/resources with IRB Office Knowledgeable, experienced staff Continuing Education Flexibility and revisions to process Shared experiences with colleagues Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes No Yes No Yes Yes Yes Yes Questions? Join us for the afternoon discussion: Date: November 5th, 2007 Time: 3:30- 5:00pm Location: TBD Topic: Clinical Trials Office – Best Practice discussion on Data Management / Monitoring/ Audit/ “Costing” •FDA and ICH Compliance •Non-Standard of Care (i.e. “research”) Charges •Monitoring at sites geographically apart or in different environments: private practice, hospitals Contact Information • Collette Houston, Memorial Sloan-Kettering houstonc@mskcc.org • Linda Marks, Sutter Health – Sacramento marksl1@sutterhealth.org • Meaghan Reyes, Hospital for Special Surgery reyesm@hss.edu