CRO Perspective on Connecting Advocacy and Industry to Advance Patient-Centric Medicine
Premier Research’s VP, Global Head of Medical Affairs describes how they are connecting biotechs to the right patient advocacy groups and bringing the patient voice to change endpoints, reduce participation burden and elevate overall trial awareness.
Where are you seeing the biggest shifts in patient-centricity across pharma?
One of the most significant shifts I’ve observed is how early in the development process companies are engaging individuals with lived experience to inform patient perspectives—specifically in shaping target product profiles (TPP) from early asset development. There’s a growing recognition, especially within larger pharmaceutical organizations, that understanding how a therapy’s mechanism of action addresses patient needs should begin in the preclinical phase. In some cases, companies are now incorporating the patient voice even before a product reaches the clinic, using those insights to help define the TPP from the outset.
A decade ago, patient engagement typically occurred closer to product launch or in the post-marketing phase. Today, there is growing recognition that delaying patient input may lead to missed opportunities. Organizations that integrate patient insights earlier in drug and device development are beginning to see the positive impact of a more structured, intentional, and patient-informed value model.
What is the role you’re playing in advancing patient centricity in drug and device development?
We view our role as facilitating a three-way partnership, between us as the CRO, the sponsor, and the patient advocacy groups (PAGs). For small to mid-size biotechs who may lack the internal expertise or resources to effectively engage with advocacy organizations, we provide strategic connections to the appropriate groups.
This ensures that the patient voice is meaningfully integrated throughout the asset development lifecycle —from informing on lived experience and unmet needs, to protocol design, to patient-informed endpoints, clinical trial barriers, and enablers.
How can patients shape protocol design for greater outcomes?
Patient feedback is invaluable when developing a clinical trial protocol. It can inform key design elements such as inclusion/exclusion criteria, patient-relevant endpoints and patient-informed value elements, efficiencies for study visits and schedule of events, and enablers supporting study enrollment. Early incorporation of this input helps identify and address barriers that might prevent participation—ultimately reducing recruitment and retention challenges.
For instance, a study that requires frequent clinic visits may unintentionally exclude diverse or underrepresented populations. Being mindful of the time and logistical demands placed on participants is critical. Leveraging supportive strategies—such as telehealth visits, transportation assistance, or childcare support—can help reduce patient burden and broaden access to participation.
Can you share an example where patient involvement positively impacted the protocol?
One area where patient feedback can have a significant impact is in the selection of study endpoints. In a recent example, a sponsor added fatigue as a secondary endpoint based on direct input from patients. Although the protocol already included clinically meaningful outcomes, this patient-relevant addition reflected a specific concern that had initially been overlooked but was elevated as a critical quality-of-life parameter commonly reported by patients.
Fatigue can be a debilitating symptom for many patients. It can affect the ability to complete daily tasks—whether it’s grocery shopping, going to work, or picking up children from school. It can also impact things like social status and may consequently affect mental health. While quality-of-life measures like this may not always carry the same regulatory weight as primary endpoints, they represent aspects of treatment options that matter most to patients. These insights should be given strong consideration alongside traditional clinical outcomes required to meet broader stakeholder needs.
What are some of the ways you’re raising awareness of clinical research opportunities?
There is still a lot of inherent stigma and fear around clinical research, and education is a critical factor for improving awareness, interest, and trust across our communities. Last fall, I joined the Steering Committee for the Reflections Collective, a cross-industry consortium aiming to sustainably improve representation in and access to clinical research participation.
The mission of Reflections is to raise awareness, expand access, and increase community participation in clinical trials. We officially launched the initiative on October 13, 2024, with a public art installation in the heart of Atlanta, Georgia. The event aimed to reframe how clinical research is perceived by leveraging immersive, community-centered art. It was incredibly impactful to see the community engage with the concept of medical research through a shared and accessible medium. We often speak in industry terms, but art gave us a way to connect through a common language
Through the Collective efforts, we’ve already seen a measurable increase in patients engaged in clinical trials within Atlanta. In one case study, community engagement through an integrated, co-created framework between PAGs, trial sites, and a sponsor has resulted in a 6-week acceleration of study start.
Our vision for Reflections extends beyond a single installation or location. We're building a sustainable model that can be adapted and implemented in diverse communities worldwide, creating lasting change in how clinical research engages with underrepresented populations.
How are PAGs moving the needle in drug and device development?
PAGs provide critical insights that extend well beyond clinical development, influencing the commercial success of medical products. By offering a deeper understanding of the patient journey—from diagnosis through treatment—PAGs help shape clinical trials, ensure new treatment options address unmet patient needs, and help inform go-to-market strategies to support product adoption at launch.
PAGs’ input into study protocols ensures trials are better aligned with patient priorities, improving recruitment, retention, and overall trial experience. They also help identify key challenges patients face during treatment, such as managing symptoms or navigating care, which can inform both clinical design and supportive services.
How are PAGs contributing to the commercial, regulatory and other spaces?
On the commercial side, PAGs contribute to a clearer understanding of what patients value, helping guide product positioning, messaging, and the development of services that support long-term engagement. Social listening—monitoring patient conversations in online communities—complements these efforts by capturing unfiltered, real-time feedback on treatments, side effects, and unmet needs.
PAGs also play a growing role in regulatory engagement. As agencies increasingly seek patient perspectives, PAGs are well positioned to advocate for patient-relevant endpoints and influence policies that reflect the real-world needs of their communities.
Beyond the clinic, their collaboration continues through support for post-market surveillance, real-world evidence generation, and adherence programs. By keeping the patient voice central at every stage of the product lifecycle, PAGs help ensure that medical products are not only scientifically sound, but truly bring patient-informed value to the individuals they are meant to serve.
What is your advice to biotechs and pharma about continuing to move ahead with patient-centric drug development?
There are opportunities throughout the product lifecycle to integrate patient engagement and centricity earlier in the development process. For biotech and pharma organizations—regardless of their development stage—my recommendation is to bring in the patient voice as early as possible. This includes gathering patient input on protocol design, encouraging development teams to think critically about the appropriate patient population, and considering factors like demographic balance and representation from the outset. Early engagement helps ensure that development strategies are grounded in the real-world experiences and priorities of the patients they aim to serve.
Partnering with PAGs is a particularly effective way to facilitate this. Their collaboration can also build trust and improve outreach to underrepresented communities, ultimately contributing to more inclusive and representative research.
While some regulatory guidances have shifted under the new administration, the industry as a whole continues to prioritize representation in clinical trials. There’s a growing recognition that scientific rigor requires inclusive research. Ensuring that trials reflect the diversity of the patient population is fundamental to developing effective, equitable treatments.
