Patient first… patient centric… patient focused… Do these terms sound familiar? These phrases have become a regular feature in clinical research language. They appear in brochures, mission statements, and recruitment materials. They signal a commitment to prioritising patient needs and well-being.
These terms are used with good intentions. But has common usage made them just a superficial label? Do they truly reflect the deep commitment that they signify? Many patients perceive these terms as hollow and meaningless. Being put “first” translates to signing forms and sitting in waiting rooms—not shaping the study, not being truly heard.
Putting patients first must be more than a slogan. It needs to be a standard of care, respect, and collaboration. If clinical research is to evolve into something genuinely equitable, it has to centre patients not just in process, but in power. That means co-creation, transparency, and accountability—well beyond what’s captured in a consent form.
The future of patient-first approaches goes beyond the paperwork. Putting patients first must fundamentally mean more than just securing informed consent. Consent is a crucial ethical minimum, not the pinnacle of patient partnership. This change begins with treating patients not as passive recipients of care, but as drivers of research decisions. And it continues with every decision that prioritises their experience, feedback, and wellbeing.
When Rhetoric Outpaces Reality
“Patient first” is a great motto, but it runs the risk of becoming corporate jargon or a marketing claim that has no substantive changes in practice.
And consent is not a substantive change. You may have participated in a trial that was designed with the notion that the informed consent process alone fulfils the “patient first” promise, and felt like you really weren’t a priority for the rest of the trial. While informed consent is essential for autonomy and clinical trial ethics, it doesn’t automatically guarantee the patient’s experience, input, or broader needs are prioritised throughout the trial.
Sponsors must also avoid superficial gestures. Some examples are advisory panels without real influence, feedback surveys that go into a void, or patient materials developed without patient input. These illusions of partnership undermine trust rather than build it.
Defining Authentic "Patient First" Principles
Change begins with deep respect for patients as partners. It’s going beyond politeness to genuinely valuing patients’ lived experience as expertise. It’s respecting their time through efficient visits and fair compensation and respecting their dignity and choices. It’s shifting from viewing participants as “subjects” to seeing them as active collaborators in the research process.
The next step is meaningful inclusion and co-design. This step involves patients early and continuously in trial design not just in reviewing finished documents. It means seeking input on things like research questions, protocol feasibility, endpoint selection, site selection, and communication strategies. It ensures patient-facing materials are truly understandable, accessible, and co-created with patients.
Transparency is what holds everything together. Patients need clear, honest, ongoing communication about the trial’s purpose, procedures, risks, potential benefits, and progress. They rely on a commitment to sharing both positive and negative trial results with them and the whole patient community in plain language. Patients appreciate openness about how their data will be used.
A well-rounded patient support system isn’t complete without empathy. Sponsors must actively work to reduce the burden of participation through travel support, flexible scheduling, and user-friendly technology. They need to understand the holistic needs of participants beyond the specific trial procedures and provide clear channels for questions and concerns.
Voices Calling for Substance
Discussions within the community, for instance on professional platforms like LinkedIn, often highlight the difference between trials that merely claim to be “patient-first” and those that demonstrate it through tangible actions like co-design or truly responsive communication. These conversations underscore the demand for authenticity in clinical trial ethics. The following LinkedIn post is just one example of this invaluable resource.
Patient First? What That Really Means… Saying “patient-first” doesn’t make it true. It’s easy to put “patients at the centre” in a mission statement. It’s harder to design trials that actually work for them. Being patient-first means more than offering a consent form and a thank-you gift. It means designing trials that fit around real lives—not the other way around. It means respecting time, effort, and emotional load. It means offering clarity at every stage, not just at the start.
If a trial requires multiple long-distance site visits, is it patient-first? If participation creates financial strain, is it patient-first? If communication is confusing, inconsistent, or absent, is it patient-first? Here’s a better test: Would I want my partner, parent, or child in this trial? If the answer is “not really,” it’s not patient-first.
Why Real "Patient First" Matters: The Impact
A real “patient first” mindset reaches far beyond one specific trial. It builds foundational trust. Authentic respect and inclusion are cornerstones of trust between patients and the research enterprise.
It improves trial quality and relevance. Patient input leads to better-designed trials that are more feasible, recruit better, retain participants longer, and measure outcomes that are truly meaningful.
It accelerates progress. Engaged, trusting participants are key to faster enrolment and completion of trials, speeding up the development of effective treatments.
It’s ethically imperative. Fundamentally, treating participants with respect and valuing their contribution is simply the right thing to do. Real transformation means giving patients the power to lead, not just respond. It means embedding them into the DNA of the research process, from strategy to results. That’s what makes the difference between inclusion and empowerment.
Keith Berelowitz | Founder & CEO
Keith Berelowitz is the Founder of pRxEngage, a company redefining patient engagement and retention in clinical trials using living experience, proven methods, and AI.
