Starting the Conversation A SWOT, So What, & Now What? Summary, Implications & Next Steps

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1 Starting the Conversation A SWOT, So What, & Now What? Summary, Implications & Next Steps Arthur Slutsky, M.D. ACAHO Research Co-Chair & Vice President Research, St. Michael s Hospital

2 Presentation Overview 1. Why are we doing this? 2. SWOT Analysis Summary Strengths, Weaknesses, Opportunities, Threats 3. Now what? Next Steps International examples, questions for discussion

3 Density of Recruiting Clinical Sites (# of sites/population) and, Average Annual Growth Rate (2007)

4 Implications (So What)? Patients Access to cutting edge therapies Hope for the future, empowering effects Clinicians Knowledge of innovative technologies and approaches Better care for patients, knowledge of disease & options Health Care Organizations CTs associated with better quality - standards, protocols Ability to attract leading clinicians & researchers Industry/Government(s) Strengthen local operations Jobs, revenues, products, services

5 What does Industry want and what do Clinical Investigators want? Speed Quality Cost Relationships

6 SWOT Analysis: Strengths in CTs 1. A tradition of excellence World firsts and major breakthroughs 2. Reputation of researchers, organizations and outputs Quality and integrity in research, practice, and outputs 3. Diverse population (ethnicity, race etc) Methodological advantages 4. Disease/population specific networks and charities Ex. Infrastructure for Cardio., Rheum., Cancer, Paeds. CTs 5. Evidence of an interested and supportive public ALS, MS etc.

7 Strengths 6. Collaborative intent, volunteer efforts, and goodwill - People and organizations willing to participate 7. Publicly funded healthcare and provincial funding Capacity for accreditation standards, quality and procurement 8. *National & federal leadership CIHR Strategic Plan/SPOR/Government departments 9. *Provincial commitments and initiatives Strategic planning to increase competitiveness 10. *National progress on various operational barriers Model Clinical Trials Agreement, work in Ethics Reviews

8 Weaknesses re CTs 1. Canada 10 + health care systems, regulatory environments,. Large distances with only 33 + M population 2. Ethics approvals Inconsistent and cumbersome processes within and between organizations, provinces, and regions 3. Contract negotiations Delays in start up time due to lengthy contract negotiations 4. Recruitment and retention Difficulties recruiting sufficient numbers and types of patients and then ensuring that they follow the protocol

9 Weaknesses 5. Costs High healthcare costs result in higher costs for CTs. Poor funding for overhead and indirect costs of research 6. Career support & HHR shortages Diminishing career support for clinician scientists Increased workloads, decreased incentives

10 Opportunities re CTs 1. Confluence of Interest by relevant parties National Clinical Trial Summit Federal R&D Review Panel & STIC Provincial initiatives & investments CIHR Strategic Plan & SPOR Associations & members willing to help facilitate Academic Healthcare Organizations/ACAHO Rx&D Members/Rx&D Population-based networks, N2, CAREB, Others Public support to mobilize political support 2. Areas of clinical excellence Networks/infrastructure that support clinical trials Reputations and track record of Canadians

11 Opportunities 3. Lots of international examples to learn from Options of best fit and lessons learned Blank slate to build without dismantling 4. Strong tradition of basic research High academic impact & KT potential 5. Strong collaborative culture across Canada E.g. Canadian Critical Care Trials Group (CCCTG) 6. Databanks and electronic health records Untapped potential due to technological deficiencies

12 Threats to CTs 1. Unintended consequence of interventions REB standards sometimes well intended interventions cause problems (e.g., CGSB) 2. Decreasing ability to leverage hospital resources in the conduct of clinical trials 3. Diminishing training and career support & incentives Decreased career support for clinician scientists Competition for clinical researchers internationally 4. Increasing focus by governments to cut costs by use of generics and increasing linkage by pharma of access and research spend

13 Threats 5. Cumbersome regulatory/heath environments Failure to recognize CTs under SR&ED Tax policy 6. Real & perceived issues re cost, quality and speed As weaknesses and as threats to further investment 7. Lack of structure for integration No where to discuss, monitor and resolve issues 8. Other countries are getting their act together Cheaper, more efficient Head offices are off shore - decreased investment in Canada

14 International examples China Meetings of industry and Chinese FDA Standards to follow as part of Clinical trial site designations Harmonization with international practices Domestic and international companies treated same Low costs Spain Mandatory electronic registry of all clinical trials Pharmacists leading staff in clinical trials as a result of nursing shortages Clinician scientists recruited abroad through mergers of successful midsize

15 International examples United States Vision for clinical trials as a large public works project with centrally available researchers, business support and participants In Cancer, dedicated funding for designated clinical trial sites who must set up and be accountable for infrastructure United Kingdom UK Clinical Research Network (UKCRIN) provides single interface for industry, single ethics review, business process support, budgeting, patient recruitment, clinical site coordination Organized in regional and disease specific networks

16 What does Industry want and what do Clinical Investigators want? Research Ethics Speed Cost Quality Relationships

17 Speed 1. Creating central access points for industry As marketing interface and as problem solving mechanism 2. Collaborating across geography to Increase population size Standardize legislative environment 3. Develop data and electronic submissions Expedited application processes Real time capacity for identifying problems 4. Contract template 5. Streamlined ethics reviews

18 Cost 1. Address operational barriers through Centralization Standardization 2. Consider product uptake and surveillance issues Use of products or services in regions participating in CTs 3. Develop effective networks 4. Leverage our databases more effectively Some of the best in the world, but others catching up

19 Quality 1. Clinical trial site designations Standards and accreditation Funding and accountability systems for infrastructure 2. Develop networks of excellence 3. Effective ethics review with monitoring 4. Recruitment and retention of patients 5. Patient and staff education

20 Relationships 1. Branding for excellence Selecting clinical areas of focus Identifying and marketing strengths Describing population and infrastructure 2. Consider product uptake and surveillance issues Use of products or services in regions participating in CTs 3. Capacity Building & Incentive Management Are CTs an attractive proposition for all parties? Clinical site engagement, tx and IP policies

21 Possible Roadmap for National Organization of Clinical Trials Driving Factor Current Challenges, Threat, Action Item Possible Solutions/ Next Steps Leadership/ Responsible Person Timelines Speed Contracts Ethics reviews Patient recruitment Common templates Standards/ protocols Clinical sites & Industry, ACAHO, Rx&D Fall 2011 Winter 2012 Quality Retention of patients Protocol Completion Training & support Data capacity Resources for patients/staff Development of databases Clinical sites, ACAHO with Government & Industry support Spring 2012 Ongoing Cost More efficient primary endpoints Increased use of data bases (e.g. ICES) Winter 2012 Relationships Marketing/Branding Capacity building Integration SR&ED review Develop Strategy New Forum Government FPT, Associations, CIHR etc. ASAP

22 Innovation for Impact 1. Different kinds of trials: Knowledge-driven trials Linkages with basic sciences Smart trials with economic impacts E.g., Reimbursement Pragmatic trials 2. Beyond drugs Health strategies - Delivery of care Behavioural interventions to optimize patient compliance with meds Natural health products Devices 3. Increased use of data bases for end points

23 Next Steps (Now What)? Strategic Action Planning 1. Develop an action plan to gain short term wins Ethics reviews Recruitment and retention Administrative issues Cost structures 2. Strategic infrastructure considerations What mechanisms do we need to tie our initiatives together? How are all of these activities going to be coordinated? How do we market our strategic advantages? 3. What else does our action plan need to consider? Areas of clinical focus? Other elements?

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