As part of my campaign for site-coordinator and study-monitor centric clinical trials; we first need to understand how to exploit a vulnerability in human psychology.

As a security analyst, this is the way I look at things – exploits of vulnerabilities.

In 2007, B.J. Fogg, founder and director of the Stanford Behavior Design Lab taught a class on “mass interpersonal persuasion. A number of students in the class went on to apply these methods at Facebook, Uber and Instagram.

The Fogg behavior model says that 3 things need to happen simultaneously to initiate a behavior: Motivation (M), ability (A) and a trigger (T).

When we apply this model to patient-centric trials, we immediately understand why patient-centricity is so important.

Motivation – the patient wants therapy (and may also be compensated for her participation).

Ability is facility of action. Make it easy for a patient to participate and they will not need a high energy level to perform the requisite study tasks (take a pill, operate a medical device, provide feedback on a mobile app).

Without an external trigger, the desired behavior (participating in the study in a compliant way) will not happen.  Typically, text messages are used to remind the patient to do something (take treatment or log an ePRO diary).  A reminder to log a patient diary is a distraction; when motivation and ability exceed the trigger energy level, then the patient will comply. If the trigger energy level is too high (for example – poor UX in the ePRO app) then the patient will not comply.    Levels of protocol adherence will be low.

The secret is designing the study protocol and the study UX so that the reminder trigger serves the patient and not the patient serving the system.

People-centric clinical trials

Recall – that any behavior ( logging data, following up) requires 3 things: motivation, ability and a trigger.

A site coordinator can be highly motivated. She may be well trained and able to use the EDC system even the UX is vintage 90s.

But if the system doesn’t give anything back to her; reminders to close queries or to follow-up are just distractions.

The secret is designing the study protocol and the study UX so that the reminder trigger serves the CRC and CRA and not the CRC, CRA are serving the system.

When we state the requirement as a trigger serving the person – we then understand that it is not about patient-centricity.

It is about people-centricity.