The past few years have been transformative for clinical trials. We've seen a shift in regulations, the impact of the pandemic, and a surge of promising new treatments. Many sponsors and investigators within the clinical trial ecosystem notably embrace the concept of patient centricity to design studies that are more tailored to participants and feasible.
This shift is reflected in the technologies that support clinical research. Patient engagement has become paramount as the industry transitions to virtual technologies that improve data collection and insights. The industry is starting to recognize that patient feedback and involvement are crucial for improving patient outcomes and the success of the trial itself.
Open and sustained patient engagement
Patients and caregivers possess unique knowledge and expertise related to their conditions. This ‘experiential knowledge’ is invaluable for research and development (R&D). By incorporating patient perspectives into trial design and conduct, sponsors can improve data quality and participant recruitment and retention. However, developing effective engagement plans with patient communities requires strategy and intentionality. Those developing patient engagement plans must first bridge gaps between study participants and the industry to achieve true patient centricity. This means putting patients and their caregivers first, ensuring open and continuous dialogue, and iterating on platforms to improve user experience over time.1
Historically, clinical trial teams focused on eliminating subjective bias. However, recent thinking has shifted towards a more holistic approach. Social scientists have shown us that subjective experiences provide unique insights that improve research rigor and feasibility and ultimately lead to more equitable and meaningful outcomes for communities. This approach relies on scientific methodology to minimize bias while incorporating patient perspectives to broaden and deepen understanding of patient communities.
Research has traditionally had a top-down structure, with the industry making decisions without patient/caregiver involvement. Alternatively, this patient-centric methodology recognizes patients and caregivers as essential stakeholders in determining research needs and priorities. It's heavily influenced by community-based participatory research, patient and caregiver advocacy legacy, and the disability rights movement. It requires the industry to actively embed patients in our processes and prioritize what matters most to patient communities. In turn, we can establish a more equitable research ecosystem that makes clinical trial operations and outcomes more accessible and meaningful. Providers and sponsors can then build mutually beneficial relationships with patient communities, improve technology usability, and advance product design and implementation. Ultimately, electronic clinical outcome assessment (eCOA) technologies play a pivotal role in this pursuit, transforming the ease with which patient-reported outcomes are collected and managed.
Relationship-building and research
All stakeholders can reap significant benefits from their studies with strategic patient engagement strategies. These benefits include:
- Building mutually beneficial relationships with patient communities, including fair compensation for advocates' insights.
- Gaining a deeper understanding of the patient journey and gathering valuable usability insights, ultimately influencing the prioritization of features most attractive to users.
- Embedding patient and caregiver insights directly into product vision and design, fostering continuous improvement through iterative technology advancements.
- Recognizing patients and caregivers as stakeholders in every aspect, requiring buy-in from all levels, including operations, logistics, product development, and marketing.
Organizations such as the Patient-Centered Outcomes Research Institute (PCORI) and the European Patients' Academy on Therapeutic Innovation (EUPATI) offer significant engagement resources, including support for methodology, implementation, infrastructure development, and dissemination. The FDA has also published valuable guidance on best practices for securing robust and meaningful patient and caregiver input to inform medical product development and regulatory decision-making.
The invaluable insights and engagement of patients and caregivers drive the evolution of clinical trial technology. By recognizing their role as essential stakeholders and innovators, the industry is moving towards a more equitable, patient-centric research ecosystem. Through continuous, iterative patient engagement, sponsors and trial teams can build mutually beneficial relationships, gather valuable insights, and embed patient perspectives into product design and implementation, ultimately improving clinical outcomes and advancing medical research.
Kristy Birchard is the product owner for Patient Engagement at YPrime, a clinical trials software firm.
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