Patient engagement and patient recruitment are two very different activities that often intersect. Engagement activities often involve broad solicitation of feedback to understand how a particular disease state affects a person’s daily life. The engagement to solicit feedback can come in many forms such as speaking engagements, patient panels or online surveys. Patient recruitment consists of the strategy and activities to increase clinical trial awareness among specific populations. Understanding the differences and the intersection points of patient engagement and patient recruitment can lead to a more appreciative look at not simply why we need the information, but how the information can be used to inform and transform clinical trial design.
There is a set framework with which to view these activities.
During the last few years, the clinical trial industry has been buzzing with terms like patient engagement, patient insight, patient input and patient feedback. Many of these terms are used interchangeably, but it’s sometimes helpful to start with the basic definitions, as there are distinct differences between the terms (see figure).
The WHAT, HOW and WHO
Patient engagement is the ideal result that will ultimately aid all clinical research. We are all striving for informed, aware patients who have sought a clinical trial as a treatment option or for purely altruistic reasons. It is our goal to have interested, vested study participants who have a stake in being 100% compliant, completing the study and providing quality data. We want them to share their positive experience with others and consider clinical trials an option for their family and friends.
One method in obtaining engaged study participants is to solicit input or feedback from patients and potential clinical trial participants. Patient sharing can provide information to study teams on how the study will impact them.
This insight can also provide valuable information to study teams, depending on when in the development process it’s obtained. Whether it’s the framework for study re-design, development of the patient recruitment and retention strategy or the creation of study communication tools for patients and site staff, insight from patients and trial participants can demonstrate the need to better explain the background behind challenging visit schedules, study procedures or strict IE criteria.
Consider the following example to clarify the distinction of the three terms: The study team desired to improve engagement among clinical trial participants, so they solicited input through a patient panel, in an attempt to gain insight into how the strict visit schedule would affect patients’ trial participation and long-term adherence.
Why do people bother obtaining patient feedback? There are several reasons why partnering with patients to provide insights can aid in the study design to ensure that the actual burden for the patient is identified and assessed. This insight can be quite different from the perception of the site staff, PIs or KOLs during the protocol development and feasibility processes. Soliciting patient input and gaining insight can uncover obstacles to recruitment, compliance and retention that may not have been previously identified by healthcare and trial teams. Armed with real patient insight, we can remove, reduce or mitigate these barriers. For example, the information can lead to a variety of changes, including trial design transformation, appropriate time and travel reimbursement or simple operational issues like priority scheduling and concierge transportation services.
Engaging patients is an activity that will be taken on by many different areas of responsibility within an organization across the drug development process. The desired result is to create trial design with patients in mind. It is not enough to ask patients about their fears, motivations and preferences unless we are willing to take the next steps of transforming how trials are designed and healthcare solutions are deployed.
Melissa McCown has worked in the clinical trials industry for 20 years. She currently provides recruitment strategy development and project management as a consultant with MCM Communications & Consulting LLC. Email her at email@example.com
Ashley Tointon has more than 20 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry. Currently she provides recruitment expertise, strategy and leadership as Principal Consultant of Accelerate Clinical Enrollment LLC. Email firstname.lastname@example.org or tweet @AshleyTointon.
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