Discover actionable frameworks to incorporate the patient voice throughout clinical trials and ensure study design delivers both regulatory value and real-world outcomes.

Guest: Lisa Lea – Director of Patient Insights, Merck

LinkedIn: Lisa Lea

With over 20 years in biotech and clinical development – 18 of those in pulmonary arterial hypertension – Lisa leads global strategies to embed patient perspectives into every phase of research at Merck.

Clinical trial success increasingly depends on moving beyond tokenistic patient engagement towards approaches that deliver measurable value. Recorded live at COG Bay Area, this session features Lisa Lea, Director of Patient Insights at Merck, as she shares operational frameworks and firsthand experiences for integrating patient perspectives early and often throughout study development.

Lisa draws on decades of clinical and industry leadership to clarify what meaningful patient engagement really looks like, why regulators and payers now expect it, and how study teams can systematise input to improve trial design, recruitment, and data integrity. Real-world vignettes underline how adapting protocols – even small adjustments – can avert site and patient loss, while strategic engagement with advocacy groups transforms both design and recruitment outcomes.

Key themes include trends in regulatory expectations, practical avenues to gather patient feedback, and tools to quantify the impact of engagement. Whether you oversee protocol development, feasibility, or operations, you’ll come away with a concrete checklist to embed patient insight across study endpoints and execution.

00:03:09 – “Nothing about us, without us”: Why early patient involvement sets the foundation for relevance, retention, and success in clinical trials.

00:04:49 – 80% of clinical trials miss recruitment goals, with preventable patient burden as a key factor – the case for patient-driven protocol design.

00:05:58 – The evolution of patient engagement post-HIV/AIDS activism and how regulatory expectations have transformed over the past three decades.

00:07:03 – Practical definition of patient-focused drug development and the FDA’s systematic approaches for capturing patient and caregiver input.

00:08:00 – Concrete benefits: Patient engagement improves recruitment speed, retention, data relevance, diversity, and streamlines protocol amendments.

00:10:42 – How and where to embed patient voice, from prioritizing advocacy partnerships to pragmatic steps during protocol development and feasibility assessments.

00:12:43 – Examples from site operations: The operational consequences of burdensome visit schedules and how patient input can safeguard enrollment.

00:15:40 – “Beyond tokenism”: Strategies for feedback loops that demonstrate value to patients and foster true partnership.

00:17:01 – Common operational challenges – cultural resistance, lack of structure, and compliance concerns – and proven solutions to address them.

1. Engage patients early and often – feedback at protocol development and feasibility planning stages is critical to avoid costly amendments and study delays.
2. Use advocacy partnerships, patient advisory boards, and real-world data sources to identify barriers and needs that might otherwise be overlooked.
3. Create clear, structured feedback loops and share outcomes so patients see how their input drives tangible improvements in studies.