A frequency/consequence-based technique for visualizing and communicating uncertainty and perception of risk.

This chapter presents an approach under development for communicating uncertainty regarding risk. The approach relies on a risk imaging technology that decomposes risk into two basic elements: (i) the frequency of each kind of harm associated with a hazard and (ii) the adversity of each of those harms. Because different kinds of harm are often measured along incompatible dimensions, adversity is quantified on an ordinal scale. Frequency is quantified on a ratio scale. Sampling error, measurement error, and bias all contribute to uncertainty about frequency. Differences in opinion, measurement error, and choice of dimensions lead to uncertainty about adversity. In this chapter, risk is imaged as an area circumscribed by uncertainty bounds around all of the harms. This area is called the risk profile of a hazard. Different individuals and groups respond to uncertainty and risk differently, and the risk profile can be further focused to visualize particular risk perceptions. These alternate risk visualizations may be contrasted and compared across management choices or across different risk perceivers to facilitate communication and decision making. To illustrate the method, we image published clinical trial data.

A cost-effectiveness approach to the qualification and acceptance of biomarkers.

The flow of new medicines to patients depends on the development of new biomarkers and their correct interpretation, yet there are no widely accepted and practically applicable criteria that facilitate adequate biomarker qualification. As a result, case-by-case qualifications are based on subjective assessments that do not lead to optimal decisions for patients, which have contributed to the 'stagnation' in drug productivity identified by the FDA. An alternative is to qualify biomarkers in terms of cost effectiveness using a set of principles that enable the evaluation of biomarkers even with incomplete knowledge. This approach could minimize harm to patients, improve access to medicines and reduce healthcare costs.