The process of bringing a new treatment to market can be a long, arduous journey. On average, it takes ten years for a treatment to travel all the way from clinical trials to market approval.1 Keeping patients engaged and informed throughout a lengthy clinical trial can be difficult as initial enthusiasm is replaced by confusion, frustration, or lack of interest.
Although the global pandemic highlighted the industry’s need for meaningful patient engagement, many trial operators struggle to maintain engagement throughout the course of their studies. We will take a look at sustainable ways to introduce and maintain patient engagement in your trials from initial outreach to final outcome.
The Long Road to Patient Engagement
You have likely heard that 70-90% of clinical trials fail to meet their recruitment targets and those that do face high patient drop-out rates.2 Even despite the rising adoption of decentralized technologies and a greater emphasis on patient engagement, many trials still suffer.
Experts are finding that considering and incorporating the patient perspective into the trial development process is key for achieving:
- Better patient health outcomes
- Research that addresses unmet needs
- Patient-centric protocol design
- Lower patient burden
Yet despite these proven benefits, patient engagement is not seen as a standard practice. There is a multitude of tools and frameworks available, but many stakeholders invest in engagement strategies that are short-lived, lack transferability between teams, or prevent a consistent, sustainable approach beyond the first few trials.
If patient engagement is pursued superficially—by focusing on too much standardization or prioritizing provider outcomes—it cannot result in a tangible change to the patient experience.
As Mary Varghese Presti, VP of Life Sciences at IBM stated3, “To be patient-centric, you need to know going into this union what that patient really cares about. You need to understand their preferences, value the time they give, and make it as seamless as possible for them to participate. Some people who commit to studies are not totally aware of what they’re signing up for because the consenting — and entire— process can be overwhelming. Or they don’t sign up because it’s overwhelming. Technology, focused on enabling an elevated patient experience, can help improve enrollment and reduce the chances that patients will drop out of studies.”
Engagement efforts should focus on the following outcomes to achieve long-term success:
- Focusing on protocols and technologies that prioritize—and improve—the patient experience.
- Adding engagement efforts and technologies that reduce participation burden.
- Increasing efficiencies and identifying ways to reduce redundancies in trial participation.
If clinical research is a journey, then sponsors and CROs need a concrete roadmap to achieve systematic, scalable, and sustainable patient engagement. Long-term patient engagement requires a culture of consistency, processes that drive stakeholder alignment, and resources to support sustained engagement efforts. We will explore proven frameworks of engagement that can be applied throughout each stage of your study to effectively sustain momentum.
Understanding the patient experience is key to identifying what motivates patients to enlist in a study and what causes them to withdraw. Patients need to feel supported and valued from initial outreach to study closeout. Experts suggest taking time to map your patient’s journey at the onset of a trial to develop research questions and outcomes that are more aligned with patient and caregiver needs.
Recognizing all stages that make up the patient journey is the first step to designing them in a patient-centric way. It helps clinicians better understand patient expectations, design protocols that are more focused on patient outcomes, and enhance the overall participant experience.
Conduct Patient Research
Patients are experts in living with their diseases; yet, few are tapped into for assistance designing protocol specific to their disease. In fact, only half of all trials seek patient input before finalizing study protocol and less than 20% seek outpatient input on study design.4 Understanding how patients are impacted by their condition helps increase knowledge of disease symptoms and burdens, ensure the study design is culturally safe and incorporates the patient voice into study protocol.
Patient research can be collected in several ways including:
- Engaging via patient platforms or networks
- Hosting patient-led focus groups
- Conducting one-on-one interviews (in-person or via telehealth)
- Orchestrating protocol design workshops
- Establishing two-communication between patients and the clinical team
The method of engagement will depend on your unique study needs. Interviews can reveal more detailed opinions than surveys or patient portals and can be used to gauge a patients’ understanding of treatment, their trial expectations, and what matters most to their involvement. These one-on-one interactions can also help establish trust with minority populations who notoriously get less time with their clinical teams.
Focus groups or group-led research allows for discussions or debates between patient cohorts that can be particularly helpful if a diverse group is brought together, as well. This collaborative approach involves patients as partners in their care and helps to improve efficiencies by collecting more meaningful outcomes, increasing patient satisfaction, and developing more thoughtful outreach materials.
When conducting patient research, trial operators should consider:
- What motivates patients to register for a trial and agree to take on the foreseen/unforeseen burdens?
- What financial, geographical, technological, and physical burdens will they be expected to take on?
- Are the consent and intake forms clear and digestible?
- What data collection is necessary and how is that being communicated?
- How will the patient be expected to remember what is expected of them?
Host Patient Surveys
Surveys help provide quantitative and qualitative data that can inform trial design, recruitment strategies, and retention efforts. They can be conducted before, during, or after a trial to obtain continuous feedback for improvement. Surveys can be accompanied by intake or consent forms to see how well the patients understand the information and maximize eligibility criteria. Surveys can be especially helpful when conducting research into diverse patient populations to understand industry perceptions, unforeseen burdens, or overly specific inclusion criteria. With surveys, trial operators can better gauge how their patients like to receive information (platform, time, and frequency) so they can adjust protocol to meet their patients’ needs.
Patient and caregiver advisory boards regularly support clinical research but are largely underutilized as partners in the process of protocol development. In reality, advisory boards are one of the most cost-effective and high-value ways that clinical trials can improve patient engagement. With direct access to patients, they can be a powerful tool for understanding and minimizing trial burden. A growing number of trials report collecting input from advisory boards because they amplify the amount of quality patient feedback on a variety of trial elements – including protocol designs, endpoint measures, trial supply, technology solutions, and outreach materials.5
Advisory boards represent a major bridge in clinical research. For many sponsors and CROs, advisory boards help them obtain ongoing qualitative feedback over a longer period of time than an interview or focus group. Advisory boards help establish trust, which results in more meaningful feedback from patients. In fact, the average advisory board patient panel recommends 8 changes to patient-facing materials, 3.9 to informed consent forms, and nearly 2 to visit schedules, assessments, and drug administration.5
User testing is growing in popularity as sponsors and CROs look for ways to minimize costly and timely protocol adjustments. Without patients testing out trial materials, it may not be obvious what changes should be made to the participant experience. User testing allows patients to assess digital platforms, patient portals, electronic consent forms, and other printed materials to determine how informative and intuitive they are. Patients can identify ways to optimize a platform from a design or navigation point of view, while also assessing written material for clarity.
Clinical research is an ongoing process. To maintain patient engagement throughout the entirety of a trial, clinicians must note the changes to processes, procedures, and outcomes. As trial design feedback is implemented, assess whether new supporting materials are needed to re-educate or inform patients of new trial information. These bilateral exchanges of knowledge keep patients informed and strengthen adherence.
Patient engagement extends beyond the final site visit or patient-reported outcome. To encourage future trial participation and leave patients with a positive experience, be sure to establish a standardized follow-up post go live. Prior to the end of a study, understand what the patient’s expectations are when the trial ends. Make sure to thank patients for their time and participation in the trial and create space for them to share feedback on their experience. Not only will taking this time make them feel valued and appreciated in their care, but it can also create an opportunity to collect positive learnings to take into future trials. Your patients will walk away feeling more inclined to participate in future research and encourage others to participate. Your trials will benefit from feedback that can be carried over to future research.
Patient engagement is a journey. Building a sustainable plan for patient engagement can feel overwhelming, but the benefits it can have on your clinical research outcomes are unprecedented.