Benefit-Risk Assessments

Benefit-risk preference assessments are a specific application of stated-preference methods and are used to determine how your patients and other decision makers perceive the benefits of your treatment features and their tolerance for possible risks.  

Given available treatment choices, patients may be willing to accept certain risks in order to gain the benefit of treatment—risks that others might consider unacceptable.  Discrete-choice experiments (DCEs) and other stated-preference methods provide scientifically robust ways to measure preferences and predict the decisions patients, caregivers, and physicians will make when provided with a set of actual treatment options.

Benefit-risk assessments demonstrate the net benefits of treatments by quantifying the relative importance of benefits and risks and a patient’s maximum acceptable risk (MAR). If the actual risk exposure is less than MAR, then patients experience a positive net benefit from having access to the treatment.

Quantitative estimates of maximum acceptable risk can help you design effective risk management strategies throughout the product development, regulatory, and post-marketing lifecycle.

Stage Risk Management Strategies
Product Development We can help you compare patients' perceived benefits and risks to help guide your product development decisions in cases where early data indicate the possibility of an adverse event.
Regulatory Approval The voice of the patient (caregivers and physicians) matters for regulatory approval. Patients and patient advocacy groups frequently provide anecdotal evidence for product evaluations, but FDA regulators have expressed interest in those benefits and risks being quantified. Our work includes developing DCEs that have been included in successful submissions to FDA advisory committees.
Post-Marketing Risk management plans must consider the potential risks of medical interventions to a small number of patients against the potential benefits of the same interventions to a large number of patients. Additionally, interventions designed to minimize the risk to patients require understanding behavior that can lead to adverse events. Off-label prescription drug use and non-adherence can occur when there are systematic differences between physician and patient risk tolerance, and regulators’ explicit or implicit judgments regarding acceptable risks. By quantifying the differences among various stakeholder groups we help our clients develop effective risk-management programs.

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