Building a benefit-risk framework for new medicines
CMR International Institute for Regulatory Science
June 2009
The CMR International Institute for Regulatory Science has made significant advances in outlining a common framework for the assessment of the benefits and risks of new medicines.
Developing strong relationships with the regulatory agencies across the globe is key to the growth and popularity of the Emerging Markets Program from the CMR International Institute for Regulatory Science, a Thomson Reuters business. This program brings together regulators from emerging countries with academics and industry representatives to discuss ways to improve the regulatory processes to expedite patient access to medicines.
During a recent trip through Asia, Larry Liberti (Institute VP), Professor Stuart Walker (Institute Founder), and Dr Neil McAuslane (Institute Director) met with members of the Chinese SFDA, Center for Drug Evaluation, where they presented the results of several Institute research and development initiatives, particularly in the area of benefit risk. Â
Recently, the Institute has made significant advances in outlining a common framework for the assessment of the benefits and risks of new medicines. Several workshops have been convened on this topic and work continues on the development and refinement of a multi-criteria decision-based model and the study of the use of that model in real-world regulatory environments. Rather than follow the traditional pattern of first developing this framework with established regulatory agencies in Europe, the United States, Canada, Japan, and Australia, Institute Workshop participants recommended that agencies from emerging pharmaceutical markets be involved in the development of the model, so that complex regional, cultural and organizational differences be considered from the start.
Building the benefit-risk framework requires:
- identification of the factors of a medicine and its comparators to be evaluated
- identification of the evaluation criteria
- assessment of the performance of the medicine and its comparators against the criteria,
- assigning weights to the criteria
- calculation of the weighted scores
- a sensitivity analysis.
Challenges to the construction of a global framework include inconsistent clinical records, lack of direct comparator data, issues of confidentiality, and the different weights assigned to benefits and risks arising from disparate culture and medical practice. Additionally, a common lexicon must be established and the evolving nature of benefit-risk throughout a medicine's life cycle has to be accommodated. Institute members agree, however, that a quantitative benefit-risk model is achievable and would result in transparent and focused communication to all stakeholders.
You can read more about the Institute work on Benefit Risk in the Proceedings of its recent Workshop:
Measuring Benefit and Balancing Risk: Strategies for the Benefit–Risk Assessment of New Medicines in a Risk-Averse Environment
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