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  • Writer: David Jones
    David Jones
  • Jan 14
  • 5 min read

Updated: Feb 18

How can clinical trials deliver better outcomes by truly centering patients—beyond just checking the box? In this COG Bay Area session, Lisa Lea, Director of Patient Insights at Merck, outlines effective practices for patient engagement that optimize study design, recruitment, and long-term relevance for sponsors, CROs, and clinical operations leaders. 

 

This session features Lisa Lea, Director of Patient Insights at Merck and an industry leader with more than 20 years of clinical research and biotech experience. With a clinical background and years spent on both site and sponsor sides, Lisa Lea has a unique perspective on translating patient insights into operational improvements in clinical development. She emphasizes practical, real-world strategies for involving patients—not as an afterthought, but as true collaborators throughout the lifecycle of clinical trials. 


Why Patient Engagement Is Essential—And More Than a Regulatory “Nice to Have” 


Patient engagement is more than a buzzword—it is becoming a necessity in both operational and regulatory dimensions. As Lisa Lea outlines, true patient engagement is defined as the active involvement of patients in their own care and in the decisions that shape clinical research.


The principle: “Nothing about us, without us”—underscoring that patients should be central, not peripheral participants in the process. 

Historically, clinical trial design has overly centered on clinicians as “end users,” but the reality is that patients are the true recipients of therapies and interventions. Involving patients early and often can proactively address patient burden, streamline recruitment, reduce costly protocol amendments, and help ensure trials meet real-world needs.


As Lisa Lea emphasizes, regulatory and payer expectations are keeping pace: increasingly, agencies like the FDA require demonstrable patient input in trial operations and endpoint justification. 

A striking data point underlined in the session: around 80% of clinical trials fail to meet recruitment goals, and much of that shortfall can be linked to patient burden and design misalignment with lived experience. For trial sponsors and CROs, this translates to stalled timelines, increased cost, and—crucially—delayed or lost opportunities to bring therapies to patients.


The Evolution of Patient Engagement in Clinical Trials 


The inclusion of patient voice in drug development is relatively recent, spurred in large part by advocacy during the HIV/AIDS crisis and formalized within regulatory frameworks over the past three decades.


Key milestones include the FDA appointing patient representatives to advisory committees in the 1990s, the expansion of patient roles in regulatory review, and the establishment of designated patient affairs offices, patient-focused drug development programs, and structured feedback mechanisms. 


Patient-focused drug development (PFDD) now refers to the systematic integration of patient experiences, priorities, and trade-offs into both study design and regulatory decisions. Programs facilitate structured approaches for collecting data not just from patients but also from caregivers—whose perspectives can provide additional nuance regarding daily challenges, support needs, and realistic expectations. 


For clinical operations professionals, this history signals more than a regulatory box-ticking exercise: it is a shift toward ongoing, two-way engagement, with patient perspectives directly informing operational touchpoints from endpoint selection to data collection methods and trial feasibility assessments. 



Operational Benefits of Embedding the Patient Voice 


Practical benefits of robust patient engagement span every aspect of clinical trial execution and optimization: 

  • Recruitment and Retention: Patient-centric trials tend to recruit faster and retain participants longer, with faster enrollment even when controlling for disease area. 

  • Diversity and Representation: Engaging with advocacy groups early improves recruitment of diverse and representative samples, aligning studies with the populations they aim to serve. 

  • Fewer Protocol Deviations: Early patient input can surface barriers (transport, testing frequency, care obligations) that, if addressed, reduce amendments and protocol deviations—significantly lowering cost and regulatory risk. 

  • Relevant Endpoints and PROs: Input on clinical outcomes and patient-reported outcome (PRO) instruments helps ensure measures are meaningful and manageable. 

  • Better Data Quality: Reducing participant burden directly improves adherence and minimizes missing or poor-quality data. 



Practical Frameworks and Tactics for Meaningful Engagement 


How can sponsors, CROs, and their site partners operationalize patient engagement?


Lisa Lea provides a sequence of actionable tactics for clinical operations teams: 

1. Start with Available Data and Advocacy Partnerships: 

  • Use free resources like the FDA’s “Voice of the Patient” reports or nonprofit group repositories to ground understanding of lived experiences. 

  • Engage patient advocacy groups early, not just to “validate” findings but to earn community trust and better map emerging needs. 

2. Conduct Advisory Panels and Early-Phase Consultation: 

  • Customized advisory boards, interviews, and surveys with patients and caregivers, ideally prior to protocol development, provide context-specific insights: What are real barriers to participation (e.g., length of study visits, travel, need for translators or childcare)? 

  • Such input makes cross-functional partnership (clinical, operational, patient advocacy) less theoretical and more actionable. 

3. Integrate Feedback into Protocol Design and Feasibility: 

  • Real-world case: An overly burdensome protocol (eight-hour in-clinic visits) led one site to decline participation entirely—an expensive, preventable outcome if patient advisors had been included upfront. 

  • Evaluate scheduling, site location, and endpoint selection with direct patient reference, not assumptions. 

4. Build Feedback Loops and Communication Channels: 

  • Patients want visibility: letting them know which feedback was implemented, and why certain suggestions couldn’t be incorporated, affirms respect and ensures future collaboration is more than tokenistic. 

5. Extend Engagement Beyond the Trial Lifecycle: 

  • Post-trial activities—such as exit interviews and plain-language result summaries—help maintain trust, optimize future protocol design, and ensure educational resources align with participant needs and expectations. 



Barriers and Solutions: Moving Beyond Tokenism 


Despite its benefits, patient engagement in clinical development is still often “nice to have,” siloed, or under-documented.

Lisa Lea enumerates well-known barriers: lack of time, limited resources, organizational culture resistance (“the way we’ve always done things”), compliance uncertainties, and challenges in identifying representative patient partners for diverse indications. 


Key solutions include: 

  • Securing early, visible sponsor leadership buy-in and dedicated budget lines; 

  • Piloting small, focused engagement frameworks to generate proof-of-concept wins; 

  • Developing templates, qualitative analysis protocols, and internal playbooks for consistency; 

  • Systematically tracking engagement-linked metrics to demonstrate impact internally and externally. 



What This Means in Practice 


  • Map patient engagement strategies into trial planning from the concept phase, not as an afterthought. 

  • Routinely check existing regulators’ resources (FDA, UPATI, patient advocacy organizations) before designing new outreach or data collection. 

  • Quantify the operational impact of patient engagement (e.g., faster recruitment, protocol amendments avoided). 

  • Clarify compliance boundaries when working with patients—establish legal guidance and consistency in consent and collaboration. 

  • Document which suggested protocol adaptations were incorporated or left out, and transparently communicate to patient partners. 

  • Use pilot programs to demonstrate value internally, then iterate and expand frameworks based on tracked performance. 

  • Collaborate with caregivers and advocacy organizations for broader, more holistic support and insight. 




Key Takeaways 


  • Early, sustained patient engagement is a proven lever for faster recruitment, reduced amendments, and improved trial outcomes. 

  • Frameworks and systematic documentation are essential for moving from anecdotal input to operational best practice. 

  • Patient burden must be quantified and minimized, not assumed away at the design stage. 

  • Cross-functional input—sponsor, CRO, site, advocacy—multiplies the value of engagement strategies. 

  • Transparent feedback and ongoing communication with patient partners are critical to establishing trust and moving beyond tokenism. 



Selected Quotes 


“If the design and the conduct and the measurement don’t resonate with patients in their real lives, participation in and retention in clinical trials—as well as the relevance—really pay a price.” 

– Lisa Lea 

“It’s not just a nice to have. Regulators and payers are increasingly expecting the patient voice to be included in the process.” 

– 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… they want to know that at least they’re being heard and their input is being valued.” 

– Lisa Lea 

“You learn some things that you even weren’t expecting to learn just by asking patients.” 

– Lisa Lea 



Links & Resources



Further Resources


For further insights from senior clinical operations professionals, listen to the full episode of COG Review Building Better Clinical Studies or visit thepbcgroup.com. 



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