New gold standard approach to optimise trial design

Our Behavioural Science enabler

The 4D Patient Map

Success derives from understanding not just what people do, but why they do it.

We use behavioural science to explain how beliefs, motivations, perceptions, habits, and practical barriers shape real-world decision-making. This helps us understand what clinical trial patients and sites would prefer to experience.

We developed our 4D Patient Map framework from Engel’s biopsychosocial model of disease first proposed in 1977.

This framework looks at trial participation across four dimensions:

Physical reality

Symptoms, disease burden and functional limitations

Emotional and social reality

Confidence, concerns, relationships and quality of life impacts

Treatment burden

Study procedures, travel, monitoring and ongoing commitment

Healthcare experience

Interactions with sites, healthcare professionals and the wider trial environment.

Putting the patient perspective at the centre creates a shared guidepost that cross-functional teams (clinical operations, patient engagement, regulatory, medical affairs, and commercial) can align around. Perspectives from other key stakeholders such as trial sites, HCPs and caregivers are further integrated to create a holistic picture of the trial ecosystem.

With a clearer understanding of where barriers and enablers exist and why they matter, trial teams can focus on practical changes that improve participation. The result is a trial designed around the lived realities of the people it is intended to serve.

Most clinical trials are designed from the inside out and built around sponsor requirements and regulatory endpoints. The consequences are well-documented: over-burdened protocols, poor site engagement, low recruitment rates and high dropout.

Science Enabled exists to change the starting point. We bring patient, caregiver and site perspectives into trial design early enough to influence the decisions that matter.

Evidence shows that trials incorporating patient and site input from the outset have 30% fewer clinical endpoints, 20% fewer inclusion/exclusion criteria and recruit to target four months faster than industry norms.

When participation becomes easier and execution feels more realistic, trial performance improves:

35%

faster recruitment times for insight-supported trials vs forecast

15%

better retention rates vs forecast

1.1

fewer global protocol amendments (from 2.5 to 1.4)

Scope of activities to support trial teams Phase I – Phase IV

We work with teams at each stage of the clinical development lifecycle, adapting our methods to the specific challenge at hand:

Trial design outline and kick-off

Structured patient, caregiver and site engagements are undertaken to surface design barriers early
Trial simulations are used to stress-test assumptions before protocol is finalised
Internal stakeholder consultations capture cross-functional risks