Bringing patients into the drug development process early has proven to save time, money and resources.
“Patient centricity” has become one of the drug development industry’s most repeated phrases. It’s printed on posters, built into mission statements and mentioned during nearly every conference keynote. But in practice, this slogan seldom reflects real action.
For over 30 years, I’ve worked in clinical research alongside brilliant physicians, scientists and executives who genuinely care about patients. Despite their compassion and expertise, I’ve seen most strategic decisions being made without ever speaking to the people we aim to serve. These aren’t failures of intent but rather result from siloed scientific, medical, clinical and business processes.
Today, in my role as chief medical officer at the clinical research organization Parexel, I’m part of a team that advocates for using patients’ perspective and input to help shape research from the start—influencing study feasibility, protocol design and ultimately our commercial success. That engagement brings many benefits to both the patients and the companies.
When patients drive progress
To improve industry research, we have to rebuild our structures around the people we serve. The first step? Inviting patients into the process from the beginning by partnering with them on how to design clinical trials and seeking to understand their reasons for participation and the burdens they face. This partnership takes many forms, including focus groups with patient advocacy organizations and consultations with patient advisors who review draft protocols.
Before a trial begins at Parexel, our patient advisors ask a simple question: Would I participate? Sometimes the answer means rethinking how often visits occur, how much time and travel are required or even what’s culturally acceptable—e.g., what’s reasonable for a patient in Boston may be impossible in Beijing.
In addition, fear and apprehension about genetic sampling and invasive tissue collection need to be taken into account and procedures need to be clearly explained in patient materials. Adaptation of patient materials and making certain procedures optional can tip the scales for a person considering a trial.
Patient-suggested adjustments can make the difference between a study that succeeds on paper and one that succeeds in practice. First and foremost, trials must be designed in such a way that patients believe that participation is possible and can benefit them or future patients. When patients see benefits rather than a burden in participation, enrollment is easier and retention improves.
Building patient-centered systems
In successful studies, science, business and patient care come together. Patient participation is a choice and requires structural partnership. Scientists must understand patients’ needs, as well as how business decisions are made. Business leaders must understand what patient-centric care really requires. Too often, patients, researchers and investors speak very different languages. Bridging them through education, empathy and collaboration is how the best studies are run.
Bringing patients into the process early has proven to save time, money and resources. At Parexel, we maintain strategic partnerships with patient advocacy groups, which provide crucial insights into patient needs, and our Site Alliance sites, a network of research sites that prioritize patient-centered practices. These partnerships drive accelerated study start-up and increased patient enrollment as well as retention. Upfront feasibility checks help prevent mid-study amendments that slow progress and drain budgets, as well as reduce dropout rates, shorten recruitment timelines, and ultimately get therapies to market faster.
In these ways, we’ve demonstrated that putting patients at the center is not simply a slogan, but a competitive advantage. When we inject empathy into our strategies and include patient voices from the start, we can design smarter trials and build long term trust.
The Business Case for Empathy
Earlier this year, I moderated a conference session with a woman who had lived her entire life with severe anemia until a gene therapy changed everything. As she told her story to a room full of researchers, I saw many people in tears. In that moment, each of us was reminded that behind our work building studies lies the very real stories of patients in need.
Moments like this can restore our purpose, helping us to find new motivation, creativity and a deeper sense of urgency. In my own work, I take time to ensure my teams understand that behind every study, scan and blood sample there is someone who is waiting for better options. Suddenly, study data represents someone’s hope for the future. Together, we work smarter, present findings with more passion and compassion, and pursue creative solutions with greater urgency.
Today, in my role overseeing clinical studies, I am fortunate to work with many clinicians who have or still do care for patients. I encourage them to share their experiences with others involved in clinical research to help extend the empathy my teams have for patients to the researchers who do not have direct patient contact.
Across drug development, companies have a choice. They can continue to treat patient centricity as a buzzword, or they can reorient their work so that patients truly sit at the center. This means creating permanent seats for patients at the decision-making table and training executives, researchers and other employees to understand the importance of their human impact. Most importantly, it means recognizing that efficiency and empathy are complementary forces that drive innovation forward.
By taking these steps to rebuild research infrastructure, we won’t just change how our industry works; we’ll change what’s possible for patients, faster.
