The timing of planning for a Risk Evaluation and Mitigation Strategy (REMS) varies, but considering all stakeholders once you begin planning is critical. This can include direct feedback from stakeholders to ensure a successful launch without needing immediate revisions. When planning a REMS program, it is important to solicit feedback from stakeholders including patients, healthcare providers (HCPs), and pharmacists prior to REMS tool design.
Key strategies to ensure success include:
- Starting REMS planning early
- Obtaining stakeholder feedback from Key Opinion Leaders
- Considering timeline implications
- Evaluating plans and procedures to determine feasibility
- Consulting the FDA REMS Website for guidance
- Factoring in stakeholder characteristics in planning and tool design
When soliciting stakeholder feedback, consider whether a qualitative or quantitative approach is best. An overview of qualitative and quantitative research approaches are listed below.
| Qualitative Research | Quantitative Research |
|---|---|
| Smaller sample size/non-representative of the entire population | Larger sample size/can be generalized to cover the entire population |
| Unstructured data collection | Structured data collection |
| Gives an open space to explore topics or areas of focus | Surveys with closed-ended questions (KABs) |
| Allows for updating questions and follow-ups in real time | Closed-ended questions that can be analyzed with numerical and statistical methods |
| Observe and interpret | Measure and test |
| Grouping of common data/non-statistical analysis | Statistical analysis |
| Research methodology is exploratory | Research methodology is often conclusive |
Some tips and best practices in getting the best feedback from stakeholders include:
- Evaluating different designs or layout options of tools or materials
- Evaluating patient materials with HCPs to ensure consistent messaging
- Testing alternative wording or language to evaluate comprehension
- Evaluating stakeholder feedback in real-time – does the plan match the reality?
- Considering the burden to HCPs and patients and developing questions to identify areas of pain points
UBC is the leading provider of risk management and REMS services. Our REMS consultation, design, and implementation aim to reduce stakeholder burden, minimize barriers to access, and ensure product safety and value. To learn more about optimal design and implementation of REMS programs, click here, or contact us here to discuss your REMS needs with one of our experts.
About the Authors
Jenn Lundmark serves as a Director of REMS Project Management for UBC. In this role, Jenn is responsible for the operational implementation and ongoing oversight of REMS with ETASU programs. Jenn joined UBC in 2021 and has more than 13 years of experience in the patient access and Risk Evaluation and Mitigation (REMS) industry.
Marita Lynott is the Associate Director of Patient & Physician Services at UBC. She has more than 20 years of experience in clinical research and healthcare communications. Ms. Lynott manages a team of graphic designers all focused on designing Risk Evaluation & Mitigation Strategy (REMS) materials for various stakeholders. She leads all Qualitative Research programs ensuring that stakeholder feedback is incorporated into the design of REMS materials and Knowledge, Attitude, and Behavior (KAB) surveys.
