Unlocking the Patient’s Voice – The Benefits of Patient Co-Creation in Clinical Research

The movement toward patient-centric clinical research tells us that our industry recognizes that many of our biggest challenges, such as poor enrollment, lack of diversity in patient populations, gaps in access for many patients, and many others, can be tackled through building and delivering better patient experiences. This is a great step in the right direction, but how do we go about improving patient experiences?

What is Patient Co-Creation?

While it may seem simple and obvious, one answer to making research work better for patients is through listening to them. This goes beyond simply asking them questions and recording responses (passive listening), but engaging in mindful and intentional active listening, often aided by technology, to capture insights that can lead directly to solutions that improve how clinical studies work. Involving patients in the study process from study design through each phase of research gives us insights that we could not possibly get elsewhere. After all, only the patients know all the details of how clinical trial participation impacts their lives. Seeking patient feedback and working to implement their insights into our research plans is called Patient Co-Creation.

Patient Co-Creation represents a fundamental shift where researchers cease thinking primarily about patients and the data needed for the study, to thinking with the patient. Patients and/or caregivers, advocates, loved ones, etc., are asked to weigh in on every facet of the study – clinical visit schedules, medication dosing, frequency of assessments, and more. By hearing the patients’ concerns, study leaders can better understand barriers to success and design studies that reflect this understanding. This can result in studies that minimize patient burdens and allow more patients to participate. Additionally, patient Co-Creation can reveal additional efficacy and safety endpoints that sponsors wouldn’t have known about without early and active patient feedback.

Key Benefits of Co-Creation

The primary goal of Co-Creation, of course, is to make clinical research work better for patients. That said, there are several other benefits that make Co-Creation a needed aspect of modern studies.

Better Regulatory Compliance Through Co-Creation

Regulators across the globe, such as the U.S. Food & Drug Administration (FDA), are aware of the value of seeking out patient input and implementing that input into clinical trials. The FDA, in fact, has given specific guidance to sponsors that participant feedback and perspectives must be considered when designing and conducting studies.(1)

Improved Representation and Diversity of Patient Populations

Collecting information from patients around their barriers to successful study participation helps sponsors to better recognize and anticipate problems that can keep specific groups of patients away. Whether these barriers are geographic (for patients living far away from traditional clinical trial sites), socioeconomic (patients who cannot afford to travel to clinical visits, nor smartphones, computers, internet access, etc.), or cultural (patient groups who may be distrustful of clinical research due to historical abuses and/or exploitation), seeking out diverse groups of patients during the Co-Creation stage of study design helps to clear the path for patients to take part in trials.

Better and More Complete Research Data

The results of co-creating studies that improve access and overall experiences for participants include better patient retention over the course of the study, along with patient populations that adequately represent the real-world population. Better retention leads to more efficient studies that produce more conclusive safety and efficacy data. Better representation of participants further strengthens the endpoint data, providing a more comprehensive look into how a new drug is likely to work for everyone that takes it.

New Innovations Spurred on By Co-Creation

Patient listening programs help to reveal the full extent of challenges that keep patients from participating in clinical trials. With a more complete understanding of these challenges, their causes, and their severity, study leaders can begin work to solve these problems. This often necessitates creative thinking and can lead to new and better ways of doing things. In this way, patient Co-Creation helps to drive new best practices, pushing the clinical research industry forward.

As we can see, there are many reasons to get started with a robust Patient Co-Creation strategy. Certainly, regulatory compliance is a direct and compelling reason to ensure study designs reflect patient perspectives and input, but the value of listening to patients goes much deeper. Successful implementation of patient input leads to better patient experiences and, ultimately, clearer and more comprehensive study data. For more information on patient Co-Creation, read our recent THREAD Report on the subject.

(1) https://acrpnet.org/2018/06/26/patient-voices-often-a-neglected-clinical-trial-resource/

Adam Kleger

Head of Client Solutions, inVibe

Since 2006 Adam has been supporting pharmaceutical clients with innovative technologies and methodologies to help the industry better understand its key stakeholders -- from the early days of social listening, to physician-patient dialogue, to private online social networks. As inVibe's Head of Client Solutions, Adam is working on his true passion -- patient-focused drug development (PFDD).