Starting the Conversation… A SWOT, So What, & Now What ... · Canadian Clinical Trial Summit September 15, 2011 Starting the Conversation… A SWOT, So What, & Now What? Summary,

Canadian Clinical Trial SummitSeptember 15, 2011

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 HospitalSeptember 15, 2011


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


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


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


Speed Quality Cost Relationships

What does Industry want and what do Clinical Investigators want?


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.


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


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


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


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


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


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


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


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 mid-size

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

International examples


Speed QualityCost Relationships

Research Ethics

What does Industry want and what do Clinical Investigators want?


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

Speed


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

Cost


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

Quality


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

Relationships


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

Possible Roadmap for National Organization of Clinical Trials


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

Innovation for Impact


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?

Documents

Starting the Conversation… A SWOT, So What, & Now What ... · Canadian Clinical Trial Summit September 15, 2011 Starting the Conversation… A SWOT, So What, & Now What? Summary,