Embedding the Patient Voice: Best Practices for Patient Engagement in Clinical Trial Outsourcing

Discover how integrating meaningful patient engagement strategies throughout clinical trial outsourcing can drive study optimization, reduce recruitment delays, and create more inclusive, effective clinical research.

Guest

Lisa Lea
Director of Patient Insights, Merck
Over 20 years of biotech and clinical expertise
Specialist in pulmonary arterial hypertension and patient-centered trial design
LinkedIn

Episode Overview

This episode, recorded live at COG Bay Area, features Lisa Lea, Director of Patient Insights at Merck, sharing actionable frameworks for incorporating real patient perspectives into every stage of clinical trial outsourcing and operations. In a session tailored to trial sponsors, CROs, and operational leaders, Lisa Lea draws on two decades of industry and clinical site experience to address the operational and strategic value of authentic patient engagement.

You'll gain a grounded perspective on how early, frequent patient input enhances CRO selection and clinical study optimization. From adjusting inclusion criteria and endpoint selection to reducing recruitment challenges and addressing protocol burdens, learn how patient-centered approaches create efficiencies and improve outcomes across the outsourced trial lifecycle.

Key topics include:

The regulatory evolution of patient engagement, with lessons for clinical outsourcing models
Operational benefits, such as fewer delays and more relevant data through improved trial design
Practical methods for embedding patient voice in trial protocols and vendor collaboration
This session offers both strategic guidance and frontline examples you can apply to clinical operations best practices, CRO selection, and effective sponsor–CRO–patient partnerships.

Key Moments

00:02:45 – Defining “patient engagement” and why it matters for clinical trial operations

00:03:59 – The real-world operational risks of omitting patient voice: recruitment shortfalls and study delays

00:06:55 – Historical drivers: How patient advocacy reshaped regulatory expectations and clinical outsourcing approaches

00:08:08 – Balancing patient risk–benefit preferences in protocol and CRO/vendor collaboration

00:09:07 – Impact of patient engagement on diverse recruitment, site selection, and CRO performance

00:10:42 – Actionable steps: Where and how to embed patient insights in the clinical development and outsourcing pathway

00:13:03 – Real example: Protocol design oversights leading to lost sites, and learnings for sponsor–CRO study teams

00:14:40 – Participants’ desire for real influence, not token feedback—building feedback loops for operational improvement

00:16:09 – Key regulatory guidances and industry resources for patient-centric trial design and clinical outsourcing decisions

00:17:15 – Overcoming practical barriers: Internal advocacy, framework creation, and pilot programs for patient engagement

Top 3 Takeaways

Early and frequent patient input—starting before CRO selection—can preempt recruitment failures and reduce costly protocol amendments, directly supporting clinical study optimization.
Establishing structured patient engagement frameworks and closing the feedback loop with trial participants strengthens sponsor–CRO collaboration and drives operational excellence.
Prioritizing patient-relevant endpoints and burden reduction creates more diverse, successful trials—delivering greater value to sponsors, CROs, and, most importantly, patients.

Links & Resources:

The PBC Group: https://thepbcgroup.com
EUPATI (European Patients’ Academy): https://www.eupati.eu
FDA Patient-Focused Drug Development Guidance: https://www.fda.gov/drugs/development-approval-process-drugs/fda-patient-focused-drug-development-guidance-series-enhancing-incorporation-patients-voice-medical
DIA Patient Engagement e-Learning: https://www.diaglobal.org/en/course-listing#

Quotes:

“Clinical trials are ultimately about people. If the design, conduct, and measurement don’t resonate with patients, participation and retention—as well as the relevance of the trial—really pay a price.” – Lisa Lea

“Engaging with patients early and often is really going to help the process and improve your clinical trials. It’s not just a nice-to-have—it’s more and more a need-to-have.” – Lisa Lea

“There’s about 80% of clinical trials that fail to meet their recruitment goals. A lot of that can be attributed to patient burden—something we can address through stronger engagement.” – Lisa Lea

“Patients do not want to feel like they’re checking a box. They want to feel like their input is valued. So providing some sort of feedback loop is key.” – Lisa Lea

“To do clinical outsourcing well, incorporating the patient voice is crucial—not just possible.” – Lisa Lea

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Further content and agendas: hhttps://thepbcgroup.com