Industry leaders often believe their clinical trial designs are patient-centric, but direct experience in community clinics reveals the significant burden placed on patients and caregivers, such as 12-hour blood draw days. This exposure leads to more practical and humane trial designs that improve real-world data collection.
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Clinical trial protocols become overly complex because teams copy and paste from previous studies, accumulating unnecessary data points and criteria. Merck advocates for "protocol lean design," which starts from the core research question and rigorously challenges every data collection point to reduce site and patient burden.
Despite industry rhetoric, healthcare technology development overwhelmingly prioritizes physicians over patients. This creates a significant gap, as the ultimate end-user's needs are often an afterthought in solution design.
Don't wait until Phase 3 to think about commercialization. Biotech firms must embed secondary endpoints in Phase 2 trials that capture quality of life and patient journey insights. This data is critical for building a compelling value proposition that resonates with payers and secures market access.
The most valuable lessons in clinical trial design come from understanding what went wrong. By analyzing the protocols of failed studies, researchers can identify hidden biases, flawed methodologies, and uncontrolled variables, learning precisely what to avoid in their own work.
The traditional drug-centric trial model is failing. The next evolution is trials designed to validate the *decision-making process* itself, using platforms to assign the best therapy to heterogeneous patient groups, rather than testing one drug on a narrow population.
To be effective, the patient's lived experience cannot remain a "soft narrative." It must be converted into hard data points—like reduced healthcare utilization for payers or influence on treatment pathways for clinicians—to become a decision-making tool they cannot ignore.
Biotech leaders must stop viewing commercialization as a post-approval task. The critical window is Phase 2 clinical trials. By embedding patient journey and quality of life insights into secondary endpoints, companies can build a compelling value proposition for payers and physicians. Waiting until Phase 3 is too late.
Beyond medical side effects, clinical trials impose a significant 'procedural burden' on patients: frequent travel, extra blood draws, and endless questionnaires. This human cost must be minimized, as it can disrupt a patient's life and limit participation for those without strong support systems.
The median $40,000 cost per trial enrollee is high because pharma companies essentially run a parallel, premium healthcare system for participants. They pay for all care and level it up globally to standardize the experiment.
The massive abandonment rate of health apps stems from a core design flaw: they are built to achieve company objectives (e.g., increase diagnosis) rather than integrating into patients' and doctors' existing workflows and behaviors, making them burdensome to use.