Do you leverage the patient’s voice in your protocol validation and study design processes?

Patient talks to female doctor

Operational consequences of decisions during study protocol development can significantly drive your R&D cost. For example, while there is a rationale behind most inclusion and exclusion criteria, sometime habits or copy/paste-failures cause major distractions. Even small mistakes in a well-thought-out protocol may lead to undesirable consequences that can kill your recruitment performance and delay your study completion for months or even years.

Using real-world insights directly sourced from your patient target group for impact analysis of study entry criteria, procedures and circumstances like time consumption, travel distances and the overall willingness of potential participants, you can benefit from real-world data-based decision making. Understanding the cost of tighter inclusion criteria and maximized procedures supports fit-for-purpose protocol design and your team’s preparedness for the operational phase – identify the ideal number of sites, as well as the 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 and successfully used in most consumer industries, and with an experienced partner can be leveraged to improve clinical R&D.

Patient interview

By the way – do you contact study exit surveys to collect feedback on the patient satisfaction with their study experience at the site, the study materials, information flow, and so on? We have seen that this not only enables you to improve your processes for future studies, but also helps to make study participation in general a better experience – and create positive image with increasing acceptance of research participation.

Do you want to learn more about how we can help you to leverage the patient’s voice? Get in touch today.