The Clinical Trials Office: Understanding Organizational Structure, Functions through a Real-World Lens

Transcription

1 The Clinical Trials Office: Understanding Organizational Structure, Functions through a Real-World Lens August 27 th 2015 YOUR MISSION OUR SOLUTIONS Huron Consulting Group Inc. All Rights Reserved. Huron is a management consulting firm and not a CPA firm, and does not provide attest services, audits, or other engagements in accordance with the AICPA's Statements on Auditing Standards. Huron is not a law firm; it does not offer, and is not authorized to provide, legal advice or counseling in any jurisdiction.

2 A Bit About Our Speakers Eric Tomasini Director P etomasini@huronconsultinggroup.com Eric has 18 years of experience in pharmaceutical, life science, contract research organization, academic medical center and management consulting environments. During that time Eric has worked across the research spectrum, to build and strengthen clinical trial offices, offices of research administration, research compliance programs, and high performance computing environments Maria Gonzalez Regional Director, Clinical Research, Clinical Program Services, Southern California Region, Providence Health and Services P maria.gonzalez3@providence.org As a research professional for over 20 years in both the academic and community setting Maria has spent the majority of her career as a research administrator of cancer clinical trials, research advocacy and minority accrual strategies/initiatives. She serves on several National Steering committees and Advocacy Boards Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 2

3 Agenda Provide context to what a Clinical Trials Office (CTO) is and how it functions Outline functional areas and their relative importance Highlight quick win and long term investment strategies Provide real world perspectives and insight Q&A 3

4 Clinical Trials Context

5 Clinical Trials Involve Complexities Cooperation among a diverse group of stakeholders including research sponsors (industry, academia, government, nonprofit organizations, and patient advocates), clinical investigators, patients, payers, physicians, and regulators is necessary in conducting a clinical trial today. -Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. Washington (DC): National Academies Press (US);

6 The clinical research lifecycle requires synergy across a myriad of business processes, information systems, organizational infrastructures and cultures

7 Why build/enhance a Clinical Trial s Office? PERIODIC ASSESSMENT OF THE CURRENT ORGANIZATIONAL STRUCTURE Even with conservative growth, increasing research volume will continue to exert pressure on the infrastructure in a number of areas Management Requirements Monitoring Consistent local baseline support Core facilities Technology Existing process automation New systems for emerging areas Improved reporting capabilities Administrative Staffing Central Admin Departments Continued growth in research will have corresponding impacts on Space Dedicated labs Interdisciplinary space Administrative Dedicated clinical research space Training Mechanisms for delivering Increasing holistic program focus Compliance Monitoring Human subjects protections Conflict of Interest Billing Compliance Financial compliance 7

8 What is a Clinical Trials Office and how does it function?

9 What is a Clinical Trials Office? Provide end-to-end professional services to investigators conducting clinical research Oversees contract and budget development and negotiation for industry-sponsored clinical trials, investigator-initiated studies, and other sponsored clinical research Manages the business requirements of engaging sponsors in clinical research, including: Medicare Coverage Analysis Clinical Trial Budgets Clinical Trial Agreements Interfaces with the Institutional Review Board Research Revenue Cycle Invoicing Research Sponsors Authors and manages policies and procedures that govern clinical trials Provides education and training for the research community Oversees adherence to research compliance 9

10 What are the Basic Components of a Clinical Trials Office? VP, Research Administration Faculty/Medical Director Director, Clinical Trials Office CTO Assistant Manager, Quality Assurance Manager, Clinical Research Budgets & Contracts Manager, Clinical Research Finance Manager, Training & Education Budget Analyst Contracts Associate Financial Analyst Billing Coordinator MCA Analyst Funding Opportunity Coordinator Pre-Award Post-Award 10

11 Pre-Award Functions Medicare Coverage Analysis Clinical Trial Budgets Clinical Trial Agreements Research Pipeline Management 11

12 Post-Award Functions Research Revenue Cycle Sponsor Invoicing Cost Transfers Account Receivable 12

13 Other CTO Functions Education & Training Quality Assurance 13

14 CTO Models EXAMPLE REPORTING STRUCTURE MODELS Model A Separate Pre-award reports through the Academic Side Separate Post-award reports through Finance function Model B Pre-award and post-award report through same function Model C Fully Integrated Sponsored Programs function covering the lifecycle of awards under single team leader reporting to either the Academic or Finance side Model D Fully Integrated Sponsored Programs function, similar to model C, but reports to an AVP Research Administration, or similar, that also encompasses all other research admin functions 14

15 CTO Models COMPARE AND CONTRAST REPORTING MODELS Model A Separate Pre and Postaward Reporting Model B1 Pre and Post-award Report to Academic Lead Model B2 Pre and Post-award Report to Finance Lead Model C Fully Integrated CTO Report to Academic and/or Finance Lead Model D All CTO Functions Report to AVP Research Admin Strengths Traditional structure, well understood in the industry Oversight by areas that are closely aligned with primary functions Ensures appropriate financial controls Enables increased communication Less possibility for duplication of efforts Strong academic leadership that may promote increased service to community Enables increased communication Less possibility for duplication of efforts Strong operations leadership that may enhance efficiency and coordination with other functions Integrates central research administration Provides seamless management of grants throughout the lifecycle Same advantages as B1 and B2 More focused attention by an executive that understands research administration Weaknesses Potential for gaps in communication Potential for duplication of efforts Potential for confusion on who controls research operations Oversight of an individual that has numerous priorities, which can be in conflict Potential risk for financial compliance issues Potential for less of a focus on services to assist PIs in finding and funding research, more focus on fiscal compliance Cultural barriers to implementation due to historically separate offices Requires team leads with both preand post-award skillset Additional layer of management, which may result in slower decision making Challenge in identifying leaders with adequate competencies 15

16 Clinical Research Management Spectrum OPERATIONAL STRUCTURE Guiding principles: Streamline operations Improve compliance Educate and mentor research faculty and staff Provide scalable infrastructure and tools Develop, implement, and report internal and external metrics Recover Operating Costs Stage 0 Informal Clinical Research Management Process is informal, undefined, or based mainly on individual experience Stage 1 Functional Clinical Research Management Excellence Process is defined within one or more functional disciplines but is not well integrated Stage 2 Operations Management Excellence Process is integrated across functional disciplines and provides a clear road map across the hospital. Stage 3 Portfolio Management Excellence Methodology is fully integrated with processes such as research strategy, and and life-cycle management and can be integrated across groups/systems Clinical trial infrastructure follows a maturity spectrum, from informal processes to fully integrated service level management operations 16

17 Quick win and long term investment strategies

18 Clinical Research Management Goals BUILDING A RESEARCH STRATEGY Project Management Financial Management Define Roles, Service Level Agreements (SLAs) and Service Recovery Mechanisms Resource Management Integrated Operations and Business Planning Match Operating Expense with Clinical Trials Revenue Portfolio Management Match Demand for Support Services With Resource Capacity Define Strategic Growth and Supporting Infrastructure 18

19 Quick Wins: what can I do in the short term to create value? Assess current governance Develop a small group of stakeholders committed to clinical trial operational assessment and improvement, asses what has proved effective (or ineffective) in the past Solicit feedback! Before you build, buy and/or invest, collect empathic feedback from end users of the CTO Internal: Investigators, Coordinators, Clinical Service Lines/Departments, Patient Financial Services External: Research Sponsors, Contract Research Organizations (CROs), Consortiums Define and collect clinical trials financial & operating metrics from existing data sources Understand your research portfolio, define areas of growth, risk and service gaps Conduct a current state assessment, determine operational gaps Based on assessment, develop hierarchy of business needs and staged implementation strategy 19

20 Long Term Investments: People & Process People Clinical research governance: (clinical research council and other clinical research programming) Organizational scaling Alliance partnerships and referral network development Proactive relationships & pipeline development with external sponsors Targeted training & education programming for the spectrum of CTO end users Process Policies and procedure development that harmonize 1) the clinical trials lifecycle (internal and external) 2) clinical services, 3) research compliance and 4) patient financial service requirements Mechanisms for internal financial controls Service level objective development and deployment Communication planning and execution 20

21 Long Term Investments: Technology Breaking down data silos Leveraging existing EMR Data Predictive analytics & data mining Feasibility, screening & enrollment capabilities Implementing a Clinical Trial Management System (CTMS) How much horsepower do I need now/will I need in the future? Is it scalable? flexible? agile? How connected are the HIMS at my organization, what are likely implementation barriers? Developing clinical trial dashboards to manage the portfolio, make informed business decisions and adopt continuous process improvement standards What data can/should be reported? (and to which stakeholders?) 21

22 Real World Perspectives and Insights from Maria Gonzalez Maria Gonzalez Regional Director, Clinical Research, Clinical Program Services, Southern California Region, Providence Health and Services

23 Providence Health and Services: System Overview Providence Health and Services ( Providence ) is the thirdlargest not-for-profit health system in the United States, with ministries across Alaska, California, Montana, Oregon and Washington. The Providence system includes over 76,000 caregivers in 34 hospitals, 475 physician clinics, 22 long-term care facilities, 19 hospice and home health programs, and 693 supportive housing units in 14 locations. The health plan covers over 436,000 members. Annually PH&S sees >30,000 new cancer cases >35,000 cardiovascular patients >25,000 neuroscience patients >25,000 musculoskeletal patients >46,000 newborns and mothers Supporting over 2,000 active studies across the system, Providence is currently making strides to align research infrastructure, through investments in technology enablers such as Lawson, Velos and HUB shared service models for IRB, budgeting and contracting support. 23

24 Providence Health and Services: Southern California Region The Providence Health and Services Southern California Region ( The Region ), serves Greater Los Angeles communities including South Bay, Westside and the Greater San Fernando Valley Area. The Region s six medical centers ( ministries ) are complimented by a network of physician offices, and several other care delivery centers. The six Regional ministries are: Saint Joseph s Medical Center ( PSJMC ) St. John s Health Center ( PSJHC )/John Wayne Cancer Institute ( JWCI ) Holy Cross Medical Center ( PHCMC ) Tarzana Medical Center ( PTMC ) Little Company of Mary Medical Center at Torrance ( PLCM- Torrance ) Little Company of Mary Medical Center at San Pedro ( PLCM-San Pedro ) 24

25 Providence Health and Services Justifying Business Need and Demonstrating Value to Leadership Assessment, Justification & Planning Building the Business Case / Plan Educating and Working With Leadership; Grass Roots Multi-Year Fiscal Proposal Good Faith & Stewardship Collaborating with Health System; Leveraging System Expertise 25

26 Providence Health and Services Providence Health and Services/Huron Support Methodology Conduct an assessment at each ministry to include an inventory of the ministry s research portfolio Organization Structure Staffing levels Processes Technologies employed All other assets used to manage the portfolio Recommend Functions for a regional office including: Governance & Structure Staffing levels & roles Supporting Technologies Provide an implementation plan to support the recommended model 26

27 Providence Health and Services Strategic investments to improve clinical research infrastructure Organizational Structure: How can Providence organizational structure and leadership most optimally support and manage the clinical research enterprise? Business Process: What is the most efficient and effective way to serve end users? People: Do we have the appropriate people to enable business processes? Technology: Is technology appropriately enabling clinical trials delivery Performance Measurement: Are we constantly evaluating and improving our performance? 27

28 Providence Health and Services Future State Vision: Pillars of Research Regionalization will support the Providence Pillars of Research, and will align with system wide infrastructure Enterprise Research Infrastructure: Technology Transfer: Commercialization of Research and Innovation HUB: Shared Services IRB, Contracting & Budgeting (and a Clinical Trials Management System (CTMS) platform) 28

29 Providence Health and Services Future State Vision: Regional, Ministry, and Study Team Level Services 29

30 Providence Health and Services: Intended Outcomes Fulfill the Providence Mission: serve our patients in the advancement of care, outcomes and innovation Understand and Meet the evolving needs of Providence Investigators across the Service Lines Enhance ministry collaboration and implement regionalized structure Improve interactions with research sponsors; establish Providence as a go to Health System Increase the region s local market research footprint and competitive position; increase collaborations (i.e. Academia) Leverage Foundation funding, grant opportunities and expand the Providence ability to match funding requirements Create a Seamless, Efficient and Compliant research environment 30

31 Q&A Session

32 Clients include: More than 90 of the top 100 research universities Nine of the top ten largest healthcare systems - ranked by Modern Healthcare Eight of the top ten largest Children s hospitals Many of the premier academic medical centers Huron Consulting Group Inc. All Rights Reserved. Huron is a management consulting firm and not a CPA firm, and does not provide attest services, audits, or other engagements in accordance with the AICPA's Statements on Auditing Standards. Huron is not a law firm; it does not offer, and is not authorized to provide, legal advice or counseling in any jurisdiction.