CHAIR: Don Steinwachs, Johns Hopkins University and EBM Roundtable Member

What challenges confront methodologically rigorous learning from experience? How can alternatives to randomized controlled trials (RCTs) and innovative approaches to generating evidence be used to confront emerging challenges: broader post-marketing surveillance; linking Phase III and coverage requirements; increasingly complex patterns of comorbidity; subgroup analysis, and heterogeneity in treatment outcomes? How might learning that is more nimble also foster innovation and discovery?

15-minute presentations followed by discussion session

Robert Califf, Duke Clinical Research Institute

Alternatives to large RCTs

David Goldstein, Duke Institute for Genome Sciences and Policy

Engaging the implications of subgroup heterogeneity— prospects for pharmacogenetics

Harlan Weisman, Johnson & Johnson

Broader post-marketing surveillance for insights on risk and effectiveness

Telba Irony, Food and Drug Administration (FDA)

Evaluating interventions in a rapid state of flux

David Eddy, Archimedes Inc.

Mathematical models to fill the gaps in evidence*