In the vast landscape of clinical research, patients stand as the primary stakeholders, their needs and experiences at the core of the pursuit of better healthcare solutions. This truth was a theme throughout CORE East, a transformative three-day event hosted by the Halloran Consulting Group (Halloran).
In particular, the panel, “Patients and Caregivers: Journeys of Struggle, Strength, and Survival Beyond Science” led by Sheila Gwizdak, Vice President and Head of Consulting at Halloran, highlighted that to improve areas where this truth doesn’t stand up, it is crucial to elevate the power of patient self-advocacy, lean into the role of clinical data, and emphasize trust and inclusivity to move through positive change.
Here, we explore the panel’s insights, and illuminate gaps in the current system, while envisioning disruptive strategies to revolutionize the industry, ultimately delivering patient-centric, meaningful outcomes.
Address the Gaps: Paving the Path to a Better Future
Bridging the Diversity Gap: Beyond mere enrollment numbers, a diverse representation of demographics in clinical trials is essential. Diversity in trials is critical because different people may have different reactions to the same treatment based on their age, gender, weight, race, ethnicity, and other factors. Since clinical trials rely on volunteers to participate, including people from diverse backgrounds can show if the treatments are safe and work well for people from all different communities. Understanding the role of participants and aligning trial goals with their needs is pivotal for meaningful results.
Comprehending Participants’ Reality: Clinical trials should not focus the patient experience solely on compensation. The full experience is about understanding all patient costs — time, money, or resources incurred by participants due to their illness. Recognizing and addressing these costs is fundamental for better representation and a comprehensive understanding of the full patient experience.
Access to Clinical Trials: Improving health literacy and sharing real-life stories from clinical trial participants can enhance the reputation of trials. Storytelling and providing credible disease-related information at the right time, especially after a diagnosis, is vital. Establishing trust within communities also requires a representative approach, featuring similar stories to connect with the audience.
Harness the Patient Voice: A Call to Action
The first step in engaging patients is through education – mindfully equipping them with clinical trials as a healthcare option, when necessary and appropriate, and knowledge about their role in clinical research before they may even begin the trial. When clinical researchers discuss the trial and the patient’s role from the beginning, clinical researchers can align trials with the realities and needs of those they aim to serve. Through communication and feedback, the patient voice can be reflected in the clinical trial design, ensuring the trial reflects the diverse population it intends to benefit.
Patients give their time, energy, and resources to be a part of a trial, and while clinical researchers need their clinical data, they must remember to push past the science and see the patient to build and sustain compassionate, patient-centered trials.
Understand Clinical Data and Alleviating Participation Burden
Transparency and clear communication with patients about the clinical data are essential for patient engagement and satisfaction throughout the lifecycle of the trial. As clinical data is essential to the health of the trial, clinical researchers must move beyond the science and not treat the patient as ‘data.’ But what does that look like?
For data to be retrieved, researchers must be aware of all the additional burdens that are placed on the patient, ranging from the location of the trial site to specific requirements for medication storage. An upfront understanding of these aspects, and an even deeper understanding of where flexibility and pivoting can come into play, fosters trust and creates a more inclusive and patient-centric environment.
Foster Patient Trust: Building Bridges of Confidence
Trust forms the foundation of successful clinical trials – trust in healthcare providers, sponsors, and researchers – to enroll and stay enrolled. Though we cannot change a patient’s prior healthcare or clinical research experience, we can make a different in the future.
Trust begins with the initial point of contact – the clinical research awareness point. If you are unsure about the best approach for your population, connect with patient advocacy groups and discuss approaches and strategies to build bridges of confidence. All these efforts will ultimately increase participation rates, engagement, and patient satisfaction.
Drive Change: A Patient-Centric Approach
To revolutionize the industry, we must shift focus from mere enrollment numbers to a more patient-centric approach. Meaningful communication with patients, authenticity across studies, engaging patient advocacy and community leaders early in the process, and ensuring patients are at the forefront of the clinical research planning are key elements to drive positive change.
Patients and caregivers should derive substantial benefits from sharing their stories with clinical researchers because it will help them be viewed as field experts, understand the drug or device development process, and have their narratives translated into case studies that drive better outcomes. Fair compensation and full comprehension of the drug or device development process add further value to their contribution.
We believe the future of clinical trials lies in a patient-centric paradigm, where the patient’s voice, needs, and experiences take center stage from the onset. By recognizing their role as active participants and collaborators, understanding the burdens they face, and establishing trust and inclusivity, we pave the way for an industry that truly serves the people it aims to help. Embracing disruptions for change and ensuring patients and caregivers are the focal points in this journey will create a brighter, more inclusive future for clinical trials.
If you’re struggling to adopt a patient-centric approach in your clinical development plan, or want to learn more about patient engagement and patient diversity, contact us today.