Sponsors are struggling with how to adapt research survey methods to meet the regulatory reporting standards of REMS assessments. Assessments need to be designed in a way that measure risk mitigation. Reports and interpretation of findings are highly qualitative and declarations of success may be inconsistent with those findings.
REMS assessments should be designed in a meaningful manner for measuring specific objectives. It’s important to start with a rational design – balance the interests of regulators, customers, and manufacturers. The design should be evidence-based and include end users in the design process. Consider the following when designing and evaluating a REMS:
- Baseline testing – Test for utility
- Does the patient comprehend the contents of the MedGuide as written?
- Will the stakeholders accept the proposed elements or systems?
- Validate the survey – Are the questions clear?
- What is the degree of difficulty in achieving a targeted level of performance?
- Beta test the system – Are the operating parameters functional?
- Program implementation – An opportunity for Sponsors to proactively track and gauge indicators of progress -
- Reach – Am I getting the message out to the targeted audiences as planned?
- Distribution – Are REMS materials being disseminated, downloaded, distributed, and/or advertised as planned?
- Compliance – Are we doing what we said we would do or are stakeholders doing what they are supposed to do?
- Performance – Is there early awareness of the program? If the program is not being implemented as planned, early corrective actions such as voluntary non-REMS tactics can be considered to achieve assessment targets.
- Stakeholder adoption – It’s important that stakeholders aren’t burdened with the REMS program. The REMS needs to be easily integrated into the workflow of the physician’s office. A few methods to help ensure adoption include -
- Ethnographic research – trained observers map incorporation or adaptations of REMS materials and processes in practice
- Stakeholder audits – chart reviews for evidence of REMS implementation and adherence
- Expert panels – gain feedback and advice from experienced users about improvements to REMS elements or processes
- REMS assessment survey – An assessment of the effectiveness of REMS programs in achieving their goals by measuring stakeholder (patients, healthcare professionals) knowledge and understanding of the serious risks associated with a product. Elements of an assessment include the plan, protocol, and survey.
- Safety surveillance – Outside of REMS assessment – Sponsors are required to report serious adverse events. Other surveillance may include targeted questionnaires, claims data analysis, and monitoring of literature.
Go beyond regulatory obligations – use your REMS assessment as a tool to guide a successful REMS program design. The value of voluntarily assessing more parameters more often cannot be overstated.