The clinical trial industry faced several challenges in the last few decades. They span from technological limitations to protocol deviations. However, patient engagement remains the source of the most pressing issue. The sector struggles with patient recruitment and retention, resulting in trials that don’t produce desirable outcomes and objectives.

The evidence shows that the core problems lie in the failure to create, design, and align their protocols with patients and patient-relevant outcomes. This article will explore strategies that sponsors, clinicians, and CROs can adopt to encourage patient engagement.

Fostering Diversity in Clinical Trials

One of the major issues contributing to poor patient engagement stems from the lack of diversity, equity, and inclusion in clinical research. To be successful, study subject groups need to reflect the population they’re targeting as accurately as possible. They must include patients with different lifestyles, backgrounds, genders, races, and more to ensure that treatments and products are equally safe and beneficial. Nevertheless, there is still a great deal of disparity in this area.

For instance, US trial participants comprise less than 1% of the Hispanic population, even though they comprise over 18% of the US population. Clinical trials also rarely gauge the sexual orientation of their patients, although numerous studies have shown LGBTQ+ populations display unique medical risks, physical and behavioural health patterns, and more. These types of oversights directly undermine the outcome of the trial.

To improve diversity issues, the industry must take patient cohorts and their distinctive characteristics into account and remove barriers preventing minority populations from joining studies. The following list explains strategies that can aid this endeavor.

• Involving patients in community-based participatory research — Clinical research can improve patient recruitment and protocols in collaboration with patients. Their involvement should help re-engineer these procedures and align them with optimal patient outcomes.
• Facilitating healthy patient-clinician communication — Years of mistrust with minority communities hindered progress toward better healthcare. Clinicians can overcome this barrier by establishing better communication channels with these groups in two ways:
  • Providing them with awareness and knowledge about clinical trials
  • Understanding how different patient cohorts differ
• Reformulating intake forms — Intake forms clinical researchers use today rarely gather information about race or SOGI (sexual orientation and gender identity). Reformulating intake forms to include these types of data requirements will help address prevalent chronic conditions among these groups.
• Implement the DCT research model — Patient drop-outs often result from subjects living in geographically remote areas, working hourly jobs, serving as single parents, and so forth. DCT or decentralized trials and the technology they rely on can make trials accessible to these patients and improve the quality of collected data.

Seeking and Leveraging Patient Feedback

Clinical research outcomes often fail to benefit patients due to poor data collection, inadequately chosen outcomes, and underpowered trials. These sorts of mistakes cost sponsors and research teams a substantial amount of time and money. They require amendments that can prolong trial development by up to 90 days and add over $100,000 to sponsors’ expenses.

Patients’ involvement in protocol design can significantly help avoid these complications. Their feedback can assist research teams in creating patient-centric trials with better outcomes and minimal need for amendments.

Clinical trials can collect feedback by:

• Including patients as advisors in steering committees.
• Developing strong relationships with patient advisory panels and advocacy groups.
• Implementing patient surveys.
• Conducting one-on-one interviews with patients.
• Communicating with patients through patient portals and networks.
• Providing opportunities for former participants to discuss their experiences.

Collected feedback should serve as a guideline for protocol design modifications, improvement of recruitment processes and materials, assistance with engagement barriers, and identification of condition-specific responses that impact trial methodology.

Optimizing Patient-Reported Outcomes

Recruiting the appropriate number and mix of patients isn’t the final hurdle for clinical researchers. Patient retention and reliable data collection are paramount for producing accurate results. Decentralized models and their use of digital health tools can help streamline these procedures and improve patient engagement.

Digital health technology such as ePRO (electronic patient-reported outcomes) solutions on patients’ mobile devices come with several perks. They allow patients to receive notifications and reminders about the treatment schedule, easily enter data in real-time and have access to information about their progress in the trial. These advantages reach another level if patients have a say in the design of ePRO to suit their needs, preferences, and lifestyles.

Patients aren’t the only party that can benefit from using cloud-based technologies in trials. These solutions would allow clinicians to:

• Make more informed decisions regarding regulatory approvals and drug labeling.
• Gain a deeper understanding of the burden of diseases.
• Monitor patients’ health in real-time and tailor care to their needs.
• Help strengthen health outcomes for patients and trial operators.

Focusing on Informed Consent

Health literacy is the foundation that underpins patients’ participation in clinical trials. It helps them understand the gravity of their health and information disclosure decisions. However, studies have found that many adults have below-average health literacy. Gaps in comprehension stemming from this problem can cause confusion surrounding consent, jeopardize trust between patients and clinicians, and result in CRO and sponsors’ revenue and time losses.

To ensure patients understand and fully consent to the trial processes they’re participating in, operators should:

• Steer clear of heavy medical jargon and stick to plain language in patient-facing forms.
• Use eConsent forms with quizzes, videos, and other gamification tactics to engage with patients with lower health literacy.
• Allow patients to express and discuss their concerns and fears about the trial with a medical professional before signing the consent documents.
• Educate patients on terminology, provide translations into local languages, supplement forms with information pamphlets, use health tech tools, and so on to make trial processes more straightforward.
• Check on patients’ comprehension throughout the trial.

Conclusion

Patient engagement is one of the pillars of every successful clinical research. However, it’s also a goal that researchers, CROs, and sponsors have difficulty achieving. Fortunately, several strategies can help overcome this obstacle. Diversifying the patient population, leveraging patient feedback, using appropriate data collection and analysis tools, and obtaining informed consent can make a siginficant difference.