Guest Column | January 24, 2025

What Is "Patient-Centric" About A Clinical Trial?

By Harry Yeates, strategy director, Langland

Senior medical checkup patient and doctor-GettyImages-1938542779

The idea that clinical trials can be — in fact, should be — designed and organized around the needs of the patients participating in them is a long-standing shibboleth of many people involved in the clinical part of drug development — certainly people on the recruitment side. Recently, however, some refreshingly to-the-point posts on LinkedIn have suggested the idea of “patient centricity” applied to clinical trials is at best poorly defined and at worst an empty promise, with potential implications for ethical consent.

So, what is understood by the term “patient-centric”? Let’s start wide, by asking if the process by which clinical trials are made available to the public is itself patient-centric. This isn’t the perspective I think most people have of the term, but surely, if clinical trials really are patient-centric, it would be easy for someone without specialist knowledge or support to find an appropriate study.

The most compelling (in the dictionary definition of the word) writing I have read about this aspect of the patient experience is Bess Stillman’s three-part essay from last year. In it, she chronicles the attempts she and her partner Jake made to find the most suitable clinical trial for him within the U.S. system. This is moving, indispensable reading that forensically describes what they had to go through to get Jake into a trial that offered anything more than just being the next one available. “Patient centricity” is nearly absent.

The version I understand, and I suspect a majority of people would recognize, is associated with a certain type of activity seen during the development and execution of a trial. For example, pharmaceutical companies convene panels of expert patients to advise on protocol design and aspects of trial conduct, which might lead to modifications such as certain procedures being made optional, and to evaluate whether their recruitment and communications strategies are inclusive. The trials themselves might be located in local community clinics, rather than large urban hospitals, and offer prepaid travel services to get to visits or seek to minimize the travel required in the first place by providing home visits from a research nurse.

In this version, we assume that a clinical trial is always going to introduce burden and disruption to the participant’s life, and we acknowledge that we can deal with that in two ways: make no allowances, or try to make the whole experience a bit more achievable. The sorts of activities discussed above are what I personally understand a patient-centric clinical trial to be.

It is possible to read the term more deeply and, arguably, more precisely, however. This is what Brad Hightower, who runs a site network in Oklahoma, was doing a few weeks ago in those posts I mentioned at the start. Brad’s main concern appeared to be that the terms imply the needs and priorities of individual patients are the pivotal concern of clinical trials, when, in reality, it’s the protocol that rules. That doesn’t mean participants should be forced to deal with the implications of poorly written protocols but, rather, that they could be better (and this is coming from someone who actually has to translate these documents into reality).

“I love patients, we need patients, patients are heroes, we're all patients but the intent of a clinical trial is not to address the needs of a patient,” he wrote in one post. “If we put more focus on how to produce better protocols, patients will win. Instead, we are often trying to figure out how to drag more patients [into] terribly written protocols,” read another.

Maybe some of this is semantics. Some of it certainly looks like frustration from a person who has to execute protocols every day and sees scope for improvement. And maybe some of it is simply about who this language is aimed at. If there is a tacit understanding within the industry that “patient-centric” means “more convenient” for the patient, but that understanding isn’t mirrored in the outside world, then clearly there is the potential to send a false message. That risk is elevated, as there are initiatives out there that overtly propose “clinical research as a care option” and even give that idea its own acronym and conferences. Valid it may be in rare and untreatable disease, but it’s a different proposition otherwise.

Where am I going with this? I guess this is enough. Follow Brad. Read Bess Stillman’s piece. Be careful with how we describe the work we do, because words matter.

About The Author:

Harry Yeates is strategy director for Clinical Trial Experience at Langland, a Publicis Health agency. He has extensive experience in developing creative identities, recruitment campaigns, and meetings that get clinical trials noticed, understood, and prioritized by potential participants, site staff, and physicians. His focus on understanding and responding to what truly motivates participants and sites allows him to share valuable insights and best practices, to help make communications in the clinical trial space more memorable and effective.