Evolving Toward Empowerment: How We Are Deepening Relationships With Patients

Susan Campbell, Global Head of Patient Recruitment, ICON

Tinaya Gray, Global Head, Diversity in Clinical Trials, ICON

Patients are more than participants; they are partners in clinical research. As clinical research evolves, so does the way we regard this relationship. Today, global regulatory pressures combined with ethical imperatives are accelerating the need for patient-centered approaches that empower patients to actively shape their healthcare decisions, considering clinical research as a treatment option.

True patient empowerment means moving beyond simply collecting patient voice data or setting diversity and inclusion targets to establishing bi-directional partnerships where meaningful patient engagement informs every phase of development. Sponsors have more tools than ever at their disposal to achieve more patient-centric trials that support deeper patient engagement as the focus shifts from mere inclusion to empowerment. Here, we explore multilayered strategies such as partnering with patient advocacy organizations, leveraging technology, enhanced patient decision-making and adopting community-based site approaches.

Regulatory focus

As regulatory guidelines continue to evolve, patient empowerment will become an increasingly central aspect of clinical research. The FDA’s Patient-Focused Drug Development (PFDD) initiative, for example, emphasizes the importance of gathering patient experience data and using it to inform clinical and regulatory decision-making. Similarly, the EMA’s guidance on patient engagement stresses incorporating patient insights throughout the development cycle to ensure better, more relevant treatments.

These initiatives signal a formal shift toward establishing patient input as a core component of trial design, making patient-centric approaches a regulatory expectation rather than an optional improvement. This regulation reinforces the importance of patient empowerment and provides a framework for sponsors to incorporate structured patient feedback, helping to standardize the plethora of practices that sponsors can utilize to elevate the role of the patient in clinical development.

Clinical development for patients, by patients

Empowering patients is not only ethically sound but operationally advantageous. Including the patient voice throughout the development process, including trial design, outcome measures, and support services enhances patient recruitment, engagement, and retention—vital aspects of a successful, efficient trial.

Collaborating with patient advocacy organizations (PAOs) and community stakeholders early in the research process builds engagement with disease groups with high levels of health literacy that provide feedback focused on clinical development. Paired insights from average patients and carers, sponsors can ensure that trials feasibly address real patient concerns, such as treatment side effects, trial duration or logistical barriers. This insight subsequently informs the trial design and support services, from the inclusion of specific digital health technologies (DHTs) to the custom financial, educational, and logistical supports that best suit patients’ unique needs. Operationally, this reduces the risk of wasting resources on ineffective or irrelevant supports and ensures sponsors are investing in the most impactful strategies.

Technology as patient tools

Technology plays a critical role in reaching diverse communities and can make clinical trials more accessible and convenient, especially for underserved and remote communities. Advanced technology and artificial intelligence are making it easier to identify and reach the right patient populations as part of study startup activities. Telemedicine platforms, wearables, and mobile apps reduce the physical and logistical burdens associated with trial participation and make it easier for patients to stay engaged. The right DHTs can improve the financial neutrality of participation in a trial and improve patient care. For instance, telemedicine visits can eliminate the need for patients to travel long distances, while wearable devices can allow remote monitoring, reducing the frequency of in-person visits.

In addition to convenience, digital tools can improve data accuracy by collecting real-time information, creating more detailed patient profiles. Within trials, DHTs and the inclusion of patient-centered clinical outcome assessments are bridging the gap between objective measurements and subjective patient experiences for better outcomes.

Though technology is a very promising tool for diverse and patient-centric trials, sponsors must implement it thoughtfully. Comparing proposed solutions to patient profiles, including preferences and baseline digital literacy, will ensure that the technology used does not inadvertently add burden or undermine the intended ease and convenience of its application. Sponsors must also navigate data privacy and regulatory requirements, ensuring patient information remains secure and consent is clear and ongoing.

Empowered, competent decision-making

Leveraging patient insights helps identify underserved communities and the barriers and burdens they face in participation, enabling more targeted accessibility and inclusion strategies. These insights also help sponsors further empower patients’ unique decision-making processes along the participation journey, highlighting the cultural and regional nuances in how diverse communities of patients and carers make complex healthcare decisions, and what information is most relevant to that process. In global trials, this process requires patient-centered language services to identify differences between clinical lexicon and patient-focused language and support conceptual equivalency so that patients receive accessible information to support their decisions.

Participants that are empowered to make informed decisions are more likely to engage meaningfully in clinical trials and remain engaged throughout. Using plain language and health literacy tools are an important element for empowering participants’ individual agency. When patients understand the trial’s objectives, procedures, and potential risks, they are better positioned to make informed decisions, stay committed, and feel involved in the research process.

Sponsors can foster health literacy by developing educational resources that explain trial processes, treatments, and potential outcomes in accessible language. Digital tools, such as integrated patient platforms, can also deliver information in user-friendly, streamlined formats that cater to different learning preferences and levels of health literacy. Sponsors who prioritize health literacy empower patients to take charge of their trial experience, enhancing retention and trust.

Embracing community

While DHTs can help remove the travel burden associated with clinical trial participation via decentralization, embracing community-based sites offers localized visit options to improve patient engagement. Hyper local site selection can be particularly effective for populations that face additional layers of logistical, financial or cultural barriers to participation. By collaborating with local clinics or pharmacies and recruiting trial staff from within the community, sponsors can create a more accessible environment for participants that is more welcoming and culturally relevant.

Community-based approaches require more emphasis on building strong, mutually beneficial relationships through deeper engagement even before a trial begins. Fostering these relationships requires more transparency and active communication around clinical trials and the disease itself to support more informed participation decisions and can include sponsoring local organizations and events, attending those events as public health communicators.

Another key to patient empowerment is follow-through; working with PAOs and community representatives throughout the trial to provide thorough information all the way through the data interpretation stage so that patients are connected to the results of their participation.

Patient empowerment is the new standard

Achieving true patient empowerment requires more than regulatory compliance; it demands a genuine commitment to treating patients as equal partners in the journey.

Sponsors that prioritize patient empowerment—through partnerships with advocacy groups, the use of technology, health literacy initiatives, and community-based approaches—are establishing new benchmarks for effective, ethical clinical research. Placing empowerment at the heart of patient-centered development aligns with current and anticipated regulatory demands and fosters a culture of respect, dignity, and inclusion. This progression toward deeper engagement with patients and communities recognizes their invaluable role in drug development. Hopefully, this progress will encourage more active participation across the global population and more representative, diverse trials to enhance research and produce more meaningful therapies.

Susan Campbell, global head of patient recruitment; and Tinaya Gray, global head, diversity in clinical trials; both with ICON