RESEARCH TRIANGLE PARK, N.C. – RTI Health Solutions (RTI-HS) is pleased to announce it is a sponsor and exhibiting company at the Third Annual Forum on Pharmaceutical Risk Management in Philadelphia, PA March 29-30.
F. Reed Johnson, PhD, RTI-HS Senior Fellow and Principal Economist, will present a talk titled "When Do Benefits Justify the Risks? Using Stated Preference Methods to Inform Risk Management Decision" on Friday, March 30. The abstract for the talk follows:
Recent withdrawals of otherwise beneficial drugs because of relatively small risks of severe side effects poses a familiar problem of how to weigh treatment benefits against treatment risks for new pharmaceuticals in the absences of directly comparable data. Using stated preference methods, we can obtain scientifically credible measures of maximum acceptable risk for specific therapeutic benefits, which indicates decisions makers' risk tolerance in such situations. This session summarizes recent application of this approach for Tysabri®. Biogen Idec submitted our study of multiple-sclerosis patients' willingness to accept treatment risks to the FDA advisory committee as part of their application for re-approval of the drug. This apparently was the first time quantitative evidence on patient risk-benefit preferences was included in a submission to FDA in support of an approval decision related to drug safety. We compare the risk tolerance of MS patients with that of adult Crohn's disease, another therapeutic are in which Tysabri® clinical trials have been conducted.
- Overview of risk-benefit tradeoffs as a regulatory problem
- Summary of methods for quantifying risks and benefits in a directly comparable metric
- Review of a recent case study of submitting evidence on patient risk-benefit preferences to the Tysabri® advisory committee
- Comparisons of risk-tolerance estimates for MS patients, Crohn's patients and parents of Crohn's children
- Evaluation of opportunities and limitation of risk-benefit tradeoff studies for new pharmaceutical
If you plan to attend the conference and would like to pre-arrange a meeting time with one of our team members please contact Andrea Mohamed, Director of Business Development and Marketing. For more information on the conference, please visit http://www.cbinet.com/show_conference.cfm?confCode=HB729.