Benefit-Risk Assessment

FasterCures is working to expand opportunities for patient perspectives to shape product development and influence regulatory decisions so that products patients value advance more rapidly from bench to bedside.

Benefit Risk Infographic 1Assessing benefits and risks is core to medical product development, regulation, and health-care decision-making. Recent legislation has opened a new dialogue between patients, pharmaceutical and device developers/manufacturers and regulatory gatekeepers about expected benefits and tolerable risks. The trade-offs between desired benefits and tolerable risks may look quite different whether you’re a patient, a physician, a regulator or a drug/device developer; they also might change over time.


FasterCuresBenefit-Risk Boot-Camp was a one-day event held in September 2014 designed specifically for patient organization research and engagement staff members, patient advocates, policy-makers and other stakeholders to hear directly from experts about how to participate effectively in research and policy activities that can enhance patient-centered decision-making about medical products in development, under regulatory review and on the market.

Tools You Can Use

Benefit Risk Infographic 2Webinar: FDA’s Patient-Focused Drug Development: The view from the other side of the table » 4/7/15

Webinar: Would you take a drug that could kill you? Understanding benefit-risk assessment in pharmaceutical products » 7/29/14

Medical Device Innovation Consortium's (MDIC) Patient Centered Benefit-Risk Assessment (PCBR) Framework » May 2015

Patient, Heal Thyself: The Next Generation » April 28, 2015

Learn more about FasterCures' work in benefit-risk and contact Kim McCleary, Managing Director