Patient engagement and satisfaction are crucial factors in ensuring the success of a study. Sponsors have traditionally played a smaller role in patient support compared to sites, yet data indicates that patients will be more likely to enroll in and complete a clinical trial when they know and trust those in charge.

When sponsors play a more pivotal role in supporting patients throughout their decision journey, from the initial awareness phase to the critical decision-making stage, they will see associated leaps in key KPIs like enrollment rate and retention.

In this blog post, we will explore best practices for sponsors to effectively guide patients through each step of their clinical trial experience.

Step 1: Awareness

Sponsors should make a concerted effort to provide patients with a centralized hub for learning about and evaluating clinical trials. This platform should be user-friendly and easily accessible, allowing patients to explore trial options effortlessly. Writing trial information in clear, understandable language is essential, ensuring that potential participants can comprehend the details without feeling overwhelmed or scared away by medical jargon.

Moreover, sponsors need to address the issue of under-representation in research. Ensuring access to trials for under-represented groups is not only an ethical imperative but also enhances the diversity of the study population and generalizability of the study findings. By actively engaging with and reaching out to these communities and ensuring all patient-facing content is understandable and relatable for them, sponsors contribute to a more inclusive and representative clinical trial landscape.

Step 2: Consideration

As patients move into the consideration phase, sponsors should provide them with transparent and comprehensive information to facilitate an informed decision. This process includes detailing eligibility criteria, the specific requirements for trial participation, and a thorough exploration of the risks and benefits associated with involvement.

It’s important to convey this information in a patient-friendly, concise, readable ICF. Sponsors should strongly consider developing infographics, schema, and other multimedia to complement the ICF for improved patient readability and to consequently improve trust and engagement. They should also provide comprehensive training to their site coordinators on specifics of language and support methods for most effectively communicating trial info to interested patients.

Transparency is key, and patients should have access to published data on the safety and efficacy of the trial. This empowers them to make informed choices about their health and well-being. In addition, sponsors should share logistical details to make participation as seamless as possible. This involves providing information on the study timeline, the number of visits required, reimbursement policies, and even the availability of childcare or other support services.

By addressing these practical aspects early on, sponsors demonstrate a commitment to supporting patients beyond the clinical aspects of the trial.

Step 3: Decision

Facilitating contact between patients and site teams is crucial during the decision-making phase. Sponsors can bridge this gap by actively sharing details about the site and study team, including any public-facing publications or press releases from the Principal Investigator. This not only humanizes the clinical trial but also helps build trust between patients and the research team.

To further assist patients in their decision-making process, sponsors should contextualize the trial within the broader landscape of available treatment options. Comparing the study to other treatments allows patients to make more informed choices that are aligned with their preferences and priorities. Sponsors can communicate this contextualization via central outreach, pamphlets, and materials provided for site staff.

Responding promptly to patient inquiries is of utmost importance. Research indicates that 80% of patients lose interest if not contacted within 24 hours of expressing their intent to participate. Sponsors should work closely with site teams to establish efficient communication channels, ensuring that patients receive timely and personalized responses. This effort not only keeps patients engaged but also contributes to the overall success of the trial by maintaining a steady recruitment pace.

Sponsors play a critical role in supporting patients throughout their decision journey in clinical trials. By implementing best practices that focus on awareness, consideration, and decision-making, sponsors can enhance patient engagement, satisfaction, and overall trial success. Ultimately, a patient-centric approach not only benefits individuals considering participating in a trial, but also contributes to the advancement of medical knowledge and the improvement of healthcare outcomes for all.