Understanding the Disconnect
Despite widespread commitment to “patient-centricity,” a substantial gap remains in how Medical Affairs teams operationalize the patient voice. According to recent industry benchmarks, 72% of Medical Affairs professionals report lacking direct access to patient insights—relying instead on retrospective data or third-party interpretations from clinicians.
This limitation has real-world consequences: misaligned clinical trial endpoints, recruitment inefficiencies, and limited utility of evidence generated for HCP engagement. In this post, we examine the scope of the gap, the underlying causes, and how Medical Affairs teams are beginning to address it—guided by evolving regulatory expectations and emerging engagement models.
Patient Perspectives: Missing from the Equation
1. Benchmarking the Shortfall
A 2023 survey by the Medical Affairs Professional Society (MAPS) revealed that although 89% of Medical Affairs leaders cite patient-centricity as a strategic priority, only 28% have established direct mechanisms to incorporate patient input into clinical planning or evidence generation.
This disconnect was reinforced in McKinsey’s 2023 Report, which ranked patient insight access as the third-most critical capability gap in Medical Affairs, following AI integration and cross-functional alignment.
2. Overreliance on Indirect Data Sources
Commonly used data sources often fail to reflect what truly matters to patients:
- Clinician-reported outcomes may emphasize objective metrics (e.g., lab results) at the expense of quality-of-life factors.
- Claims and EHR data lack explanatory context—such as reasons for treatment discontinuation.
- Delayed surveys may miss rapid shifts in attitudes, preferences, or behavior.
For instance, a JAMA Oncology study found that two-thirds of metastatic cancer trials prioritized progression-free survival, while patients cited fatigue and pain management as more impactful to their daily lives.
72% of Medical Affairs teams lack direct access to patient insights.
Root Causes: Why the Gap Persists
1. Regulatory Misconceptions
Concerns about compliance, IRB approval, and adverse event reporting often deter direct engagement. However, the FDA’s 2023 Patient-Focused Drug Development (PFDD) guidance explicitly supports patient involvement in endpoint selection and trial design. Structured, compliant frameworks are now widely available.
2. Operational and Structural Barriers
- Traditional advisory boards are time- and resource-intensive.
- Patient engagement responsibilities are often siloed within Commercial or R&D.
- Legacy tools, such as static surveys, cannot support longitudinal insight gathering.
Downstream Implications
1. Clinical Development Consequences
- Endpoints may not reflect real-world needs, leading to reduced regulatory and commercial success.
- Protocols may overlook logistical barriers, exacerbating recruitment challenges. NIH data indicates that 30% of trial delays are recruitment-related—many of which could be mitigated through early patient involvement.
2. Impact on HCP Engagement
Medical Science Liaisons (MSLs) often lack real-world, patient-reported evidence to answer HCP questions related to function, burden, or adherence—diminishing the relevance of field engagements.
Pathways Forward: Closing the Gap
Forward-thinking Medical Affairs teams are turning to more agile, compliant, and patient-inclusive approaches:
- Digital patient communities provide HIPAA-compliant, on-demand access to diverse, longitudinal insights.
- Virtual advisory models lower operational barriers and allow scalable engagement across therapeutic areas.
- Global regulatory guidance is increasingly supportive of structured patient collaboration throughout the product lifecycle.
Accelerating Progress Through Sponsored Communities
At Inspire, we support Medical Affairs teams in operationalizing patient-centricity by providing direct, compliant access to engaged patient populations across more than 3,000 conditions. Our sponsored communities offer real-time, real-world insights to inform evidence generation, support HCP education, and improve trial design.