Abstract
Background: Regulatory decision-making involves assessment of risks and benefits of medications at the time of approval or when relevant safety concerns arise with a medication. The Analytic Hierarchy Process (AHP) facilitates decision-making in complex situations involving tradeoffs by considering risks and benefits of alternatives. The AHP allows a more structured method of synthesizing and understanding evidence in the context of importance assigned to outcomes. Our objective is to evaluate the use of an AHP in a simulated committee setting selecting oral medications for type 2 diabetes. Methods: This study protocol describes the AHP in five sequential steps using a small group of diabetes experts representing various clinical disciplines. The first step will involve defining the goal of the decision and developing the AHP model. In the next step, we will collect information about how well alternatives are expected to fulfill the decision criteria. In the third step, we will compare the ability of the alternatives to fulfill the criteria and judge the importance of eight criteria relative to the decision goal of the optimal medication choice for type 2 diabetes. We will use pairwise comparisons to sequentially compare the pairs of alternative options regarding their ability to fulfill the criteria. In the fourth step, the scales created in the third step will be combined to create a summary score indicating how well the alternatives met the decision goal. The resulting scores will be expressed as percentages and will indicate the alternative medications' relative abilities to fulfill the decision goal. The fifth step will consist of sensitivity analyses to explore the effects of changing the estimates. We will also conduct a cognitive interview and process evaluation. Discussion: Multi-criteria decision analysis using the AHP will aid, support and enhance the ability of decision makers to make evidence-based informed decisions consistent with their values and preferences.
Highlights
Regulatory decision-making involves assessment of risks and benefits of medications at the time of approval or when relevant safety concerns arise with a medication
Study intervention The study intervention will be a four part structured interview consisting of a) overview of current medications and options for type 2 diabetes; b) a Multi-criteria decision analysis (MCDA) using the Analytic Hierarchy Process (AHP); c) a cognitive interview; d) evaluation of the AHP-based priority assessment procedure
We will provide the Food and Drug Administration (FDA) with a new and innovative decision making method to ensure that potentially life-saving treatments are available to patients while protecting public health
Summary
Regulatory decision-making involves assessment of risks and benefits of medications at the time of approval or when relevant safety concerns arise with a medication. With increasing pressure on government agencies to improve transparency, the Food and Drug Administration (FDA) is making significant changes to make its processes and decisions more transparent to industry stakeholders and consumers (http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/default.htm) This has included initiatives to improve the transparency and consistency of risk-benefit assessments The Institute of Medicine report on the ethics of post-marketing safety studies (http://www.iom.edu/Reports/2012/Ethical-andScientific-Issues-in-Studying-the-Safety-of-Approved-Drugs.aspx) recommended that the FDA consider systematic assessment of benefit and risk during its regulatory advisory committee meetings It recommended evaluation of the Multi-criteria decision analysis (MCDA) as one approach to group decision making during regulatory advisory committee meetings. A MCDA using the Analytic Hierarchy Process (AHP; see Methods for a description) allows us to make better decisions in complex situations involving tradeoffs by explicitly considering the risks and benefits of alternatives[4]
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