Drug Information Association Logo
Corporate Tagline

Session 3B: Health Outcome Research and Post-Approval Clinical Epidemiology Studies

Day & Time:
October 22, 1:30PM - 3:00PM


Session 3B: Health Outcome Research and Post-Approval Clinical Epidemiology Studies

Jaderson Lima, MD
Director, Medical and Scientific Alliances
Sanofi-Aventis, Brazil

Marcelo Vianna De Lima, MD,MBA
Medical Director
Amgen, Brazil

Heath systems need to adopt a new clinical research paradigm which should generate efficient data (robustness and quality), from the best available evidence. There is a big gap between what is observed in the studies with academic or regulatory purposes (for registration and marketing authorization of procedures and health products) and medical practice. Hence, there is a need to establish research that creates relevant information obtained from the "real world" for decision-making by patients, physicians, providers, industry and health administrators, ensuring the accuracy required on the design and execution of studies. We have to monitor the efficacy and safety data of products, programs and services with greater focus on the data generated in the places where they are offered (real-life effectiveness). Moreover, decision-making in health care must be based on the evidence generated by taking into account data obtained in the time course of the actions, programs and disease treatments, from the daily medical practice, which have greater relative value and culminate with the improvement of population health. Health Outcome Research (HOR) and Pos-Approval Clinical and Epidemiological Studies (PACES) are the frame of reference of these new clinical research paradigms.

Presentation(s) & Speaker(s):
Post Approval Clinical Epidemiology Studies (PACES) Main Concepts and Real-life Effectiveness' Research Role in Drug Development and Clinical Decision-making Process
John Sampalis, MD
JSS Medical Research, Canada

Evidence-based Decision-making in Health Care Management: the Role of Real-life Effectiveness Research in Public Health
Hans Fernando Dohmann
Rio de Janerio City Secretary of Health and Researcher
Fiocruz Foundation, Brazil