The Best Advice I Ever Got: Patient Centricity
As told to Abby Proch, executive editor of guest columns, Clinical Leader
Safety and efficacy — the two tenets of clinical research. Regardless of role, clinical research professionals are charged with creating, implementing, and conducting a bevy of systems, processes, and tasks that strive to uphold those critical elements of research. And who for but the patients?
Ah, the patients. The “who” behind the “why” and “how.” But given the demands of such a critically important, demanding, and paradoxically paced environment (at times glacial, at others like the rush of a tidal wave), it is challenging to keep patients as the focal point. Which is why having reminders from friends in the industry, those who grapple with that focus daily, is paramount to individual and collective success in developing life-changing drugs for patients.
To commemorate Clinical Trials Day 2024, Clinical Leader heard from those most invested in and concerned with keeping the patient as the focus. Here’s what they had to say:
Michel Reid, senior director and head, global demographics & diversity, GSK
“One of the most important aspects to remember in clinical research is that we do this to benefit people's health. This seems like an easy task, but many of us work within for-profit companies, so it's easy to get distracted by the idea of ‘competitors.’ Always remember that disease is the true competition, because a person out there is just trying to be healthy.”
Emily Epstein, clinical behavioral healthcare specialist, genetics and personalized cancer prevention (GPCP), Weill Cornell Medicine
"Innovation in clinical research often conjures images of cutting-edge technology, AI, and the quickest and easiest strategies to get from point A to B. This is undoubtedly vital. Yet, equally important is the integration of behavioral health, human connection, empathy, and personalized patient support — and while it may seem surprising, these are still innovative and groundbreaking concepts.
Advancing healthcare means valuing the perspectives of all stakeholders and embracing a multidisciplinary approach. It's about seeking out, respecting, listening, and hearing the expertise that each individual, with their unique experiences, brings to the table. This is key to our continued evolution toward patient-centric care.
True success and innovation in clinical research hinges on striking a balance between leveraging technology and fostering meaningful human connections. It involves building robust relationships and actively engaging with everyone involved in a study. By really engaging and listening to all stakeholders, we can ensure that our technological tools complement rather than replace these vital interactions. By prioritizing comprehensive patient support, we innovate in ways that truly address and meet patient needs, moving the needle forward in clinical research and care.”
Teryn Maihiot, senior manager clinical documentation, Karuna Therapeutics (A Bristol Meyers Squibb Company)
“Always remember who we are working for — the patients! When you centralize your work around those you are helping, it brings an element of humanity that makes everything we do mean so much more and provides motivation unlike any other. Also, don’t be afraid to ask questions if you have one best chances are someone else does too!”
Mark Scullion, CEO, Atlas Clinical Research
“When I first moved into the clinical research industry from a different field, the learning curve was steep. The terms and jargon made the purpose of the work difficult to comprehend, and stressful to a newcomer. However, early on, I was given a piece of advice that brought focus: Your job is to find ways to do things better; behind every data point is a human life.
Generating data is what we do: using data ‘to drive insights,’ to answer scientific questions are phrases we often repeat. To be told in my first weeks that those data represent people has grounded me and recurs to me often.
I try to keep it at the forefront to critically evaluate every idea or innovation, asking if it helps, whom it helps, and how much it truly serves those we aim to help. Innovation should not be complicated for novelty's sake.
I have had the luck and privilege to work across many countries, roles, and industry segments — from CROs to sponsors and now sites. Motivations may be misunderstood from different vantage points, but in my experience regardless of the seat occupied, there is a common desire to do things better. Building genuine, open relationships is essential to fostering deeper collaboration and understanding among peers.”
Stacy Hurt, chief patient officer, Parexel, on behalf of ACRO
"Design clinical trials that prioritize the person, not just the process. It’s crucial to recognize that patients are more than just participants in clinical trials – they are individuals with jobs, families, needs, and interests – all of the unique aspects that make them who they are as people and define their identities. As a cancer survivor, I understand firsthand how an illness like cancer can strip away these aspects from your life. The least we can do as an industry is try to maintain and fulfill the holistic needs of our patients. Instead of asking patients to upend their lives to participate, we should strive to ensure that clinical trials seamlessly integrate into patients’ existing lifestyles as a potentially life-changing treatment option."
Samantha Sharpe, CCRP
“While digitalization and decentralization efforts might save time and money, they can’t replace the in-person interaction that is often integral to the patient recruitment and enrollment process, which is a known struggle in the field of clinical research. …There is a place for optimization and technological streamlining in clinical reach studies, but a wholesale application of technology into the personal commitment of a family to participate and stay engaged in a research study isn’t one of them.”
Kathryn Walker, CEO, Revitalist
"Conducting successful clinical trials with ketamine and psychedelics requires a patient-centric, holistic approach. Proper patient screening beyond just diagnosis, extensive education, and preparation to build trust, providing a comfortable supportive environment during sessions, using empathetic individualized communication styles, maintaining strong ethical standards throughout, and offering integration support after sessions are all vital best practices. A focus on the whole patient — physical, mental, emotional, and spiritual — with thorough training for practitioners is key to helping patients navigate the vulnerable psychedelic state productively for long-term healing and development of healthier coping mechanisms.”
Sabrina Ramkellawan, president, and Kim McDonald-Taylor, Toronto chairperson, Clinical Research Association of Canada (CRAC)
“Work toward patient-centricity, diversity, inclusivity, and equity, which involves engaging with diverse patients more holistically, respecting their need to be active collaborators and fully informed decision makers. This is a cultural shift where historically clinical trials focused on the investigational product and the disease area.”
Gelise Thomas, JD, MS, director, research health equity, Clinical and Translational Science Collaborative of Northern Ohio, Case Western Reserve University
“Equity is an outcome of acting with integrity. Honesty, fairness, and decency are timeless virtues that build the foundation for sustainable relationships. Being a willing party to earn trust and become trustworthy allows for limitless collaboration and impact.”
Perla Nunes, community outreach and clinical research DEI consultant
“I celebrate all the trailblazers for their tireless efforts in advocating for change, challenging the status quo, and amplifying the voices of marginalized communities in the pursuit of health equity and diversity in clinical research. I urge all who are engaged in this work to persevere despite the challenges, knowing that your efforts are not only worthwhile but essential for creating a more just and equitable future.”
Dr. Arati Bhosale (Dr. B), co-founder and advisor, Sieve Health, and founder and principal, THQ Consulting
“Let's remember that clinical trials are a marathon, not a sprint. Our drive to introduce new solutions must be tempered with the understanding that thoughtful, paced implementation is key to sustainable success. Proactive planning is essential to avoid the pitfalls that lead to rescue situations in our trials. By anticipating challenges and addressing them early, we can maintain the integrity and efficiency of our research processes.
And, let's never forget that our ultimate goal is to improve the lives of patients. Every innovation, every effort, every long day is for their benefit.”