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P104: CIOMS XI Recommends Patients are Involved in the Development, Regulation and Safe Use of Medicines: Is Industry Doing Enough?

Poster Presenter

Lacey Leigh Lucree

Co-Founder and Partner
Truliant Consulting
United States

Objectives

Patients can provide invaluable insights into the best way to minimize risks and should be actively involved at all stages of a medicine’s lifecycle to inform benefit-risk activities; as such, we investigated whether the patient voice is consistently sought, analysed and incorporated by Industry.

Method

In January 2023, we conducted a 2-month online survey directly approaching known individuals in differing sized companies who hold senior positions within Pharmacovigilance or Risk Management across the Industry. The survey asked 16 questions, soliciting both qualitative and quantitative responses.

Results

Results were obtained from more than half of the companies invited to participate (n=16) and 63% of those companies considered the collection of patient feedback at least an average priority. By far the most consistent mechanism for collating patient feedback is through Key Opinion Leaders, with 15 of the 16 respondents leveraging these relationships to collect this information. Social media is monitored as part of collecting patient feedback by 44% of respondents; however, this responsibility is performed by varying departments, including Safety, Medical Affairs and Commercial. Large datasets (e.g., Sentinel, healthcare claims data, etc.) are reviewed for patient outcomes by 50% of respondents, again, with little consistency regarding which department bears responsibility for this activity. Note – the results presented below exclude those responses of “I don’t know” or “no answer”: The survey results demonstrated that regular analyses of patient experience data is not routinely performed by more than half of the respondents (n=11); moreover, 75% of respondents (n=12) have no process or mechanism to review the analyses of patient experience and 80% of respondents (n=10) do not incorporate patient feed back into the benefit-risk assessment on a regular basis. When patient experience data is shared across departments, cross-functional meetings are the most popular mechanism to share this information (n=10). Quality of life, reasons for discontinuing product, safety and efficacy data, treatment outcomes, data relating to patient compliance or adherence with taking the product, product accessibility, patient knowledge of competitor products, effectiveness, drug access, patient journey and patient experience with the company representatives were some of the most important pieces of patient feedback that respondents sought to collect.

Conclusion

The collection of patient feedback throughout the lifecycle of a medicinal product is aligned with global health authority (HA) expectations. The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) includes patient representation, and the United States Food and Drug Administration (FDA) encourages patient participation during its Advisory Committees. Furthermore, the Council for International Organizations of Medical Sciences (CIOMS) Working Group XI recently published its report Patient involvement in the development, regulation and safe use of medicines that emphasizes the criticality of obtaining patient feedback throughout the product development and post-marketing phases, including as input to risk management and risk minimization activities. Results from this survey indicate that significant opportunities exist for Industry to strengthen their approach for collecting and integrating patient feedback to better, and more proactively, inform benefit-risk activities. For traction to occur, sponsorship at a senior level supportive of the collection and evaluation of patient feedback needs to be obtained and cross-functional teams need to define the company position and approach. Roles and responsibilities need to be defined and the senior-level sponsorship maintained in order to make the process for collecting and evaluating patient experience data robust and sustainable. In summary, based upon the survey responses received, Industry does not appear to uniformly agree on the priority for collecting patient feedback. There appear to be few standardized approaches to seeking the patient voice and/or analysing patient experience data for incorporation into a product’s benefit-risk profile. As such, a significant opportunity exists for Industry to enhance processes to better align with global HA recommendations and expectations regarding the collection, evaluation and incorporation of patient feedback across the product lifecycle.