The Problem with Scaling Engagement… Patient engagement is becoming an industry in itself. That doesn’t mean it’s working.
The more companies that enter the space, the more diluted the message becomes. Everyone says they “centre the patient.” Few actually talk to them. Engagement at scale is only meaningful if it solves real problems. Instead, what we often see is:
- One-size-fits-all messaging that ignores cultural, linguistic, and regional differences.
- More content, not better content. If patients can’t easily find or understand trial information, engagement efforts are failing.
- Metrics that miss the point. Click-through rates and survey completions don’t tell us if patients feel empowered or included.
Engagement should lead to access, comprehension, and trust—not just more noise in an already crowded space. If the patient experience isn’t improving, it’s time to rethink the approach.
The Significance of Research
Clinical trial sponsors include pharma companies, biotech, and research institutions, and play a critical role in research. They fund and drive the complex machinery needed to develop new treatments. Their focus on operational execution, regulatory pathways, and financial viability is essential to the entire industry.
But who are they really serving? Their ultimate goal is patient benefit, which is a praiseworthy objective. But does the day-to-day focus fully reflect that? Do patients feel that the trial truly has their best interest in mind?
Sponsors have a “blind spot,” however. The necessary and intense focus required from the sponsor perspective can inadvertently create “blind spots” that obscure a full understanding of other critical stakeholders – particularly patients.
The World Through the Sponsor's Lens
Patients are sometimes quick to judge sponsors without first acknowledging the sponsor’s point of view. Sponsors’ decisions are driven by high pressure and priorities. They must meet aggressive timelines and budgets. They navigate the complex regulatory requirements put in place by MHRA, EMA, FDA, and Good Clinical Practice (GCP). Then they ensure that data quality and scientific integrity have not been compromised through this process. And on top of all that, they manage the big picture – operational logistics across multiple sites.
After they’ve put all this work into the trial, they can only watch and hope their effort achieves a successful trial outcome that leads to drug approval and market access. These priorities are understandable and vital for the success of the research enterprise, and we should not criticise these necessary functions, rather provide support to help sponsors do things better.
Identifying the Blind Spot: What Gets Missed?
Now that we can see through the lens of the sponsor, we also see their blind spot. They tend to assume that funding the trial automatically confers deep insight into the lived experience of participants. But, as you know, paying the bills does not equal full understanding. Asa father of a teenage daughter I can certainly attest to that.
At what point do patients become invisible through the sponsor’s lens?
- The True Burden: Underestimating the practical, emotional, and financial toll participation takes on patients and families (travel, time off work, invasive procedures, anxiety).
- Patient Priorities: Overlooking what outcomes truly matter most to patients (e.g., quality of life, symptom relief, ease of administration vs. purely clinical endpoints).
- Communication Barriers: Creating patient materials filled with jargon; inadequate channels for patient questions or feedback or simply the information is not available in your native language.
- Logistical Hurdles: Choosing sites or designing schedules based on sponsor or site convenience rather than patient accessibility.
- Tokenistic Engagement: Treating patient engagement as a late-stage checkbox rather than an integral part of planning and execution.
Tokenism is real. It’s evident when feedback is filtered, paraphrased, and selectively presented to fit internal agendas. It shows up when we see the same patient advisors at every event because they’re “easy to work with.” That’s not engagement. That’s curation. Sponsors who say they value the patient voice need to prove it in the places that count—trial design, consent materials, visit schedules, outcome selection, retention strategies and post study reporting to the general public.
The Consequences: Why This Blind Spot Hurts Everyone
This disconnect directly undermines the sponsor’s own goals through:
- Recruitment Challenges: Trials designed without patient input are often harder to recruit for.
- Retention Issues: High burden leads to higher dropout rates, compromising data and timelines.
- Data Relevance: Measuring endpoints that don’t reflect patient priorities may limit a treatment’s perceived value.
- Wasted Resources: Delays and dropouts increase costs significantly. This is just an overview from December 2023, “Patient enrollment in clinical trials is time-intensive and costly. In the US in 2015-2016, the average cost to recruit one patient to a clinical study was $6,500+ and the average cost to recruit a new patient to replace a lost one was $19,000+. In 2023, patient recruitment accounted for 32 percent of costs making it the largest cost driver of clinical trials. In addition to being costly, patient enrollment also can be quite challenging. Approximately 80 percent of delays in clinical trial timelines are due to patient recruitment and retention. More than half of trials fail to meet their patient recruitment timeline. In the United Kingdom, for example, the National Health Services has ‘seen a 44 percent drop in participants recruited to commercial clinical trials in the past five years’.”
- Erosion of Trust: Patients feeling unheard or overly burdened damages the reputation of the sponsor and the research process.
Closing the Gap: Towards a Patient-Informed Sponsor Perspective
Sponsors, let’s move beyond superficial consultation. This means:
- Involving patients (or experienced advocates) early in protocol design.
- Co-creating patient-facing materials.
- Establishing ongoing feedback mechanisms throughout the trial.
Actively seek out and listen to patient experiences through qualitative research, journey mapping, and meaningful advisory roles. Promote empathy and a patient-focused mindset across all relevant departments (not just patient advocacy teams). Leadership commitment is crucial. Incorporate Patient-Reported Outcome Measures (PROMs) and Patient-Reported Experience Measures (PREMs) as key indicators of success. Equip sites to support patients, but also find ways to hear directly from patients where appropriate (within ethical guidelines). Challenge internal Key Performance Indicators (KPIs) that might inadvertently penalise decisions favouring reduced patient burden if they slightly impact traditional metrics.
Keith Berelowitz | Founder & CEO
Keith Berelowitz is the Founder of pRxEngage, a company redefining patient engagement and retention in clinical trials using living experience, proven methods, and AI.
