Case Study: Protocol validation

Operational consequences of decisions in the course of study protocol developments can make a large contribution to overall costs.

While there is a rationale behind most criteria, sometime habits and copy/paste failures cause major distractions. And even when there is a well thought protocol, the consequences may be unbearable.

With a real world impact analysis of study entry criteria, procedures and circumstances like time consumption, travel distances and the overall willingness of potential participants, study sponsors will benefit from data based decision making.

Understanding the cost of tighter inclusion criteria and maximized procedures supports well thought protocol releases and the preparedness for the operational phase – right number of sites, right approach to patient identification and engagement.

In the same exercise, patients can be asked to report their expectations, the perception and which incentives may be needed to enhance participation motivation.

This type of customer analysis is widely used in a lot of consumer industries  why not bringing into research?

By the way – do you contact study exit surveys to collect feedback on the patient satisfaction with site, study, materials, information flow ,….?
We believe, this helps to make study participation a better experience – and create positive image with increasing acceptance of research participation.