- David Jones
- Jan 14
- 3 min read
Practical Insights from PBC’s COG Bay Area Session with Lisa Lee, Director of Patient Insights at Merck
Clinical trials form the backbone of medical progress, yet their success and relevance often depend on a simple but profound factor: the patient perspective. Recent discussions at the PBC Group’s Clinical Outsourcing Group (COG) Bay Area meeting spotlight this essential theme, featuring Lisa Lea, Director of Patient Insights at Merck. Drawing from over 20 years’ experience, including leadership in pulmonary arterial hypertension, Lisa Lea offered a deeply practical guide to moving beyond token gestures and genuinely embedding patient engagement throughout the trial lifecycle.
Why Real Patient Engagement Matters
Patient engagement is more than a regulatory box-tick. As Lisa Lea adamantly states, “Nothing about us, without us,” reminding innovators that clinical trials serve patients first and foremost. When the design, conduct, and measurement of trials align with real patient experience, recruitment and retention rates improve, outcomes become more relevant, and the path to operational efficiency is smoothed.
Importantly, regulators and payers now expect evidence of meaningful patient involvement. As Lisa Lea points out, 80% of clinical trials fail to meet recruitment goals – often due to patient burden. This isn’t just a logistical headache for sponsors; it delays therapies for those urgently awaiting them or, worse, derails the development entirely. Including patient voice from the onset is increasingly vital.
The Evolution of the Patient Voice in Drug Development
While patient advocacy in drug development gained momentum during the HIV/AIDS epidemic of the 1990s, its formal adoption has been relatively recent. Milestones such as the first FDA patient representative in 1993, expansion of patient input into regulatory reviews in the early 2000s, and the establishment of the FDA’s Patient-Focused Drug Development (PFDD) initiative have shaped today’s landscape.
The PFDD programme now systematically incorporates patient and caregiver insights into drug evaluation, encouraging sponsors to capture preferences, understand trade-offs, and communicate risk-benefit information to facilitate shared decision-making.
Practical Benefits of Patient Engagement
Evidence presented by Lisa Lea underscores tangible improvements from patient-centred trials:
Faster recruitment and completion: Patient-informed studies reach their enrolment targets more quickly, regardless of therapeutic area.
Greater diversity and retention: Engaging with representative patient populations reduces attrition and enhances protocol adherence.
Higher data quality: Endpoints resonate better with what matters to patients, streamlining data collection and improving relevance.
Reduced amendments: Proactively addressing patient burden minimises costly protocol revisions and deviations.
Turning Insight into Action: Implementing the Patient Voice
For teams seeking real-world application, Lisa Lea offers actionable advice:
Early & Often Engagement: Start by accessing freely available resources, such as FDA “Voice of the Patient” reports, patient stories, podcasts, and advocacy group materials.
Partnerships with Advocacy Groups: Building trust ensures patient experiences are current and accurate. Advisory panels or surveys help reveal unmet needs and daily challenges.
Protocol Design Considerations: Seek direct patient feedback on factors like scheduling, travel requirements, and completion of patient-reported outcomes (PROs). Lisa recalls a failed trial proposal requiring eight-hour site visits – an avoidable burden discernible through patient consultation.
Feedback Loops and Transparency: Patients value being heard. Closing the loop by sharing what’s changed, based on their input, avoids tokenism and builds lasting engagement.
Post-Trial Interaction: Patient engagement does not end at approval. Insights on educational resources, access challenges, and exit interviews inform future trial designs.
Overcoming Practical Barriers to Patient-Centric Trials
Despite clear benefits, embedding patient voice faces operational hurdles: lack of structure, scarce resources, cultural resistance, compliance concerns, and difficulty sourcing representative participants. Lisa Lea proposes solutions including early framework development, partnering with advocacy organisations, tracking metrics to showcase success, and pilot programmes to secure internal buy-in.
A Call to Rethink and Refocus
As the session closed, Lisa Lea invoked the ingenuity of Amsterdam’s narrow houses – built creatively within constraints. For clinical trial professionals, thinking outside traditional boxes, while respecting regulatory boundaries, is key to progress.
Meaningful patient engagement is not optional for modern trial design. With practical frameworks, leadership commitment, and authentic partnership, clinical development can truly serve those it aims to help, leading to better trials and, ultimately, improved patient outcomes.
Further Resources
Visit the PBC blog for more practical insights, guidance on patient engagement frameworks, and updates from COG meetings worldwide. To explore learning programmes mentioned, see resources from UPATI, the FDA PFDD initiative, and clinical trial advocacy organisations.
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