ISPOR RISK MANAGEMENT SPECIAL INTEREST GROUP (RM)
 
Chair:
Dennis Raisch RPh, PhD, Associate Director, VA Cooperative Studies Program, Clinical Research Pharmacy, Albuquerque, NM, USA

Leadership Group:
Suellen Curkendall PhD
, Principal Investigator, Cerner Health Insights, Vienna, VA, USA
Larry Liu MD, PhD
, Director, Anti-Infectives US Outcomes Research, Pfizer, New York, NY, USA
Anthony Lockett MD, PhD, MBA
Medical Director, MEDQP Ltd, Leeds, W. Yorkshire, UK
Ateequr Rahman MBA, PhD, Associate Professor, College of Pharmacy, Shenandoah University, Winchester, Virginia, USA


Background:

Risk-Benefit Management is the process of assessing and developing strategies to manage the risks and benefits of a situation. In the health care arena, it is the proactive and interactive process of measuring and analyzing risk while weighing the interventionsí potential benefits. This includes analyzing the interventionís effectiveness and identifying any adverse side effects.

RBM strategies include reducing the negative effect of the risk, accepting some or all of the consequences of a particular risk for the associated benefit(s) or avoiding the risk due to its outweighing the benefits. RBM stakeholders include patients, pharmaceutical and device manufacturers, government agencies, health payers, and health care professionals.

ISPOR members have the unique expertise to provide a balanced benefit v. risk approach by promoting studies that incorporate clinical, economic, and humanistic outcomes of health care interventions.

Goal:
Increase awareness of RBM, its value and its uses, for public policy, health care decision making and the safe use of pharmaceutical products and devices.
 

Tasks:
  • Promote the development and use of methods to identify and quantify the risks and benefits of medical interventions
  • Pomote the implementation of new and tested RBM interventions and their subsequent evaluation
  • Define good research practices / guidelines to conduct OR from a RBM perspective
  • Define good research practices / guidelines on how to include RBM in OR studies
  • Assess RBM from an international perspective
Work plan:
  • Provide linkages to key public policy and research organizations involved with RBM on the ISPOR website
  • Contribute to, collaborate with and/or write best practices/guidelines from an RBM perspective
  • Contribute to, collaborate with and/or write best practices/guidelines how to include RBM in OR studies

Meeting Presentation:
ISPOR 12th Annual International Meeting - Sunday, May 20th, 2007
Short Course: Introduction to Risk/Benefit Management in Health Care
Faculty: Dennis W. Raisch, PhD, Associate Center Director, Scientific Affairs, VA Cooperative Studies Program, Clinical Research Pharmacy, Albuquerque, NM, Anthony Lockett, MD, PhD, MBA, Medical Director, MEDQP Ltd, Leeds, United Kingdom; Suellen Curkendall, PhD, Principal Investigator, Cerner Health Insights, Vienna, VA

This course will provide an overview of risk/benefit management for pharmaceuticals and devices. The risk/benefit assessment process will be described in regards to stage of product development, from pre-marketing through post-marketing. Risk mitigation includes the various strategies employed by manufacturers, regulators, and health care providers, with an emphasis on international differences in risk mitigation and decision making. Risk/benefit communication processes will be described, focusing upon how decisions regarding risks and benefits of pharmaceuticals and devices are communicated to health care providers and the public. This includes direct mailing, direct-to-consumer marketing, and labeling. Real-world exercises will allow participants to discuss key topics and propose implementation strategies for risk management. This course is designed for those with a basic understanding of pharmacoepidemiology principles.
 

Activities and Accomplishments
 

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