OECD Global Science Forum Working Group

1. OECD Global Science Forum Working Group Edward L.Trimble, MD, MPH National Cancer Institute, NIH, HHS

2. Public/ academic clinical research • Wesponsor clinical research to: • Understand how best to keep people healthy • Understand risk factors for disease • Find new ways to prevent, screen for, diagnose, and treat disease • We conduct clinical research through individual hospitals, universities, clinics, and other sites, and as networks.

3. Awareness of problems • Individual countries: deficiencies in infrastructure support, delays in regulatory approval, absence of links between public/ academic research networks and regulatory/ health programs • Regional issues: EU Clinical Trials Directive • Each EC member country implemented different legislation with different interpretation

4. Why we want to work together • To leverage public investment in clinical research infrastructure and expertise • Working together we can get answers to our research questions faster; we can study rare diseases; we can evaluate interventions to improve health and treat disease in different settings and among different populations

5. Background • NIH informal working group • NHLBI, NIAID, NCI • European Medical Research Council/ European Science Foundation report • EU Clinical Trials Directive • DG Research commissioned report • Proposal from German and Spanish delegations to OECD Global Science

6. OECD GCF Working Group • Representatives from national clinical research funders, EC, ministries of health, etc • Scoping meeting in Paris spring 2010 • Full meetings in Barcelona and Bethesda 2010, Berlin 2011 • Further teleconferences and in-person meetings with co-chairs and subcommittee leads

7. Working groups • Report in almost final draft; to go to OECD GSF for endorsement in fall 2012 • Regulatory harmonization • To speed approval of joint trials • Risk-based approach • Across span of clinical research • Education and infrastructure

8. Essential elements: local • Support for clinical research from leadership • Protected time for doctors and nurses to conduct research • Data managers, informatics, biobanks • Educational programs for patients and their families about clinical research • Clinical trials offices to handle regulatory, scientific, and ethical reviews & monitoring • Involvement of patient advocates in research

9. Essential elements: national • Scientific prioritization of clinical research • Timely regulatory, scientific, and ethical review • Involvement of patient advocates • Links between health systems and clinical research • Coverage of routine patient care costs associated with research

10. Essential elements: national • Education of health professionals, public, and patients about clinical trials • Risk-based approach for regulatory and indemnity issues • Payment of research costs • Government, charity, institution, & pharma (as appropriate) • Links between public clinical research networks and regulatory authorities

11. Essential international elements • Forum for exchange of best practices and identification/resolution of barriers • Metrics to evaluate success • Forum for national and regional regulators to address issues of relevance for public/ academic trials • Global approach to clinical trials education

12. Contact information • Edward L. Trimble, MD, MPH • Center for Global Health, NCI, NIH, DHHS • Email: tt6m@nih.gov