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P51: Opportunities for Patient Engagement to Help Mitigate Research and Development Risk

Poster Presenter

Jessica Cerullo Merrill

Vice President
VOZ Advisors
United States

Objectives

Articulate opportunities for engaging patients and care partners to allow companies to mitigate research and development risk. Highlight how opportunities can uncover insights about the patient experience as well as preferences related to clinical trial design that complement company knowledge.

Method

Three approaches to patient engagement available to companies. • Standing long-term patient and care partner advisory council • One-time patient and care partner advisory board • Digital-enabled standing patient and care partner engagement through apps and platforms

Results

Different approaches to patient engagement allow companies to respond to internal questions, timelines, and diverse and representative perspectives on key questions. Here are key considerations for each approach: • Standing long-term patient and care partner advisory council o Long-term contracting creates opportunities for companies to engage patients in ad hoc manner that aligns to timeline needs and ensure patients insights are gathered in advance of key milestones. Informal sessions can be organized quickly to gather insights in timely manner. • One-time patient and care partner advisory board o Companies gather group of patients and care partners that bring very specific backgrounds and experiences to the discussion. Full-day sessions offer opportunity to co-create with patients and care partners as well as the facilitation of in-depth conversations. • Digital-enabled standing patient and care partner engagement through apps and platforms o Offers engagement across time zones and countries, increasing patients and care partners participation and additional perspectives without the demand of travel. Company representatives may interact through platforms to develop a deeper understanding of patient and care partner insights. The three articulated approaches offer companies the opportunity to mitigate research and development risk by gathering insights that address the following components of research and development. • Ensure prudent resource utilization by informing study team’s go/no go decision-making. • Improve study design to avoid costly amendments. Improvements include: o Expanded pool of eligible patients o Unearthed symptoms and quality of life factors o Uncover patient and care partner perspective on acceptable risk related to benefit o Clarify what meaningful clinical outcome means to patients and care partners o Inform operations to reduce burden of trial participation o Efficient recruitment and improved retenti

Conclusion

Obtaining insights and input on research and development beyond key opinion leaders is an essential component of mitigating research and development risk. Patients and care partners offer unique and important insights on unmet needs and clinical design that supplement the insights gained from internal experts and key opinion leaders to strengthen research and development to ensure the resulting products are valuable from all perspectives and offer benefit to all stakeholders. Insights and input can be gathered through a few key approaches, each approach offers companies the opportunity to gather and understand insights and input from patients and care partners in a manner that meets internal learning needs as well as timelines. Employing the right approach for the question is a key component to a successful engagement that support the aims of the company, the research and development team, and the patient and care partner community they aim to serve.