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A Visual Model of Patient Engagement in Benefit-Risk Assessment Through the Medical Product Life Cycle

How are we engaging patients, and how can we do better? A new visual model depicts the current state and highlights where stakeholder efforts can improve patient outcomes.


The Visual Model was created with the support of the Patient-Centered Outcomes Research Institute (PCORI)

Benefit-risk assessments of medical products, the weighing of benefits against the risks for harm from using the product for treatment, are the foundation for making decisions about the product all through its life cycle. For a medical product to truly meet the needs of the patient for whom it is intended, its benefits and risks, and uncertainties about those, must be balanced in the context of the patient’s perspective, making patient input central to benefit-risk decision-making. The September 2015 DIA conference “Patient Engagement in Benefit-Risk Assessment Throughout the Life Cycle of Medical Products” was targeted to patient, industry, academic, and regulatory stakeholders, and addressed the important challenge of how and when to best engage patient partners in benefit-risk assessments. Through a PCORI Engagement Award, a graphic facilitator worked with conference participants to create a visual model depicting both the current and future states of patient engagement in benefit-risk assessments and decision-making.

This webinar will share and invite feedback on the first iteration of the visual model. A panel of stakeholders will present the key features of the model, including:

  • Points in the medical product life cycle when benefits, risks, and uncertainties are assessed and why
  • The importance and impact of including patient experience and perspectives in the assessment and decision-making processes
  • Places in the cycle where patients engagement is currently working well, and where improvements or new approaches are needed to incorporate the voice of the patient in decision-making
  • The evolving future state in which the patient is the driver of a multiple stakeholder collaboration throughout the whole product life cycle

Featured topics

  • Stages in the medical product life cycle at which benefits, risks, and uncertainties are weighed
  • How outcomes are improved by including patient experience and perspectives in benefit-risk assessment
  • Key changes needed to fully integrate the patient voice in benefit-risk decision-making

Who should attend?

Professionals involved in:

  • Safety and pharmacovigilance – pre and postmarket
  • Benefit-risk assessment
  • Risk management/REMS
  • Clinical research
  • Study endpoint design
  • Regulatory affairs
  • Regulatory policy and review
  • Medical affairs/Medical communications
  • Patient engagement and advocacy
  • Patient organizations
  • Comparative effectiveness/Health outcomes research
  • Access to medical products

Learning objectives

At the conclusion of this webinar, participants should be able to:

  • Describe the medical product life cycle, and points at which benefit-risk assessments are made
  • Discuss the ways that information about benefit, risk, and uncertainty is used in decision-making about medical products
  • Explain the benefits and importance of including patient input and perspectives in benefit-risk-uncertainty assessments and decision-making
  • Identify when and how the patient voice could be better incorporated into benefit-risk based decision-making
  • Discuss some ways that stakeholders can work together to overcome barriers to improving patient input to benefit-risk assessment and decision-making

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