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How to Give Your Clinical Trial Participants More Control, Convenience & Comfort

Clinical research patients’ experience and engagement during a trial can greatly impact its chances of bringing successful treatments to market. Participant engagement and retention in clinical trials have been a long-standing challenge for the research industry. Some estimates indicate 80% of trials are delayed due to participant retention challenges. However, sponsors and CRO’s can curb this attrition by focusing their trials on patient comfort, convenience, and by ensuring they feel in control of their participation. Adopting a truly patient-centered study design means acknowledging that every patient comes in with differing needs surrounding these three tenets and addressing them throughout trial design and execution.

Empower Patients to Control Their Clinical Trial Experience

Patients that want to participate in clinical trials are likely interested and invested in a positive outcome for interventions that can help them or their community’s health. That often means they also want to feel a sense of control over their involvement. They want to understand what the trial is, how they will be involved, and get updates along the way. Sponsors and CROs need to identify easy ways for participants to reach this goal through clear information delivery and opportunities for involvement in critical elements of the research. In recruitment messaging, and in pre-trial interactions with recruited participants, staff should be as clear and open as possible about the experience, so the participants feel as little uncertainty as possible. As participants move through the clinical trial, it’s important to ensure they are routinely reminded of their obligations under the trial protocol to maximize adherence and ensure high-quality trial data. Hybrid and decentralized clinical trials (DCTs) should use a platform that enables regular push-notifications to the participants’ preferred device to remind them of necessary assessments, diary entries and trial visits. This helps to establish two-way communication to more control from the patients’ perspective while also delivering necessary information to trial stakeholders. A deeper sense of control could be afforded to primary caregivers who have the unique ability to reduce patient burden and maximize opportunities to remain compliant with the study protocol. Utilizing DCTs can provide greater opportunity for caregivers to play a critical role in device use, telehealth support and other study activity that are within the patient’s home.

Make Clinical Research More Convenient

Even before the COVID pandemic, lack of convenience remains one of the biggest drivers of recruitment and retention shortfalls. The participant engagement challenge is complex and often requires multiple strategies for a single trial. One strategy to consider for enhancing participant engagement is the adoption of decentralized approaches in clinical trials.

Reducing the number of site visits in a clinical trial can mean increasing trial access for an estimated 70% of potential participants living more than two hours away from a study center can also ease the burden on caregivers that may be responsible for transportation, time commitment and costs. DCT platforms enable research sponsors to design and execute DCTs to maximize participant engagement through successful trial recruitment and retention throughout the study. For example, eConsent both allows patients to easily sign off at every stage of a trial and offers CROs the ability to obtain quality data. This maximizes participant engagement as does technologies that facilitate simple and easy trial interaction for participants and caregivers.

Focus on Comfort to Increase Patient Engagement

As research evolves towards hybrid and DCT designs, many elements of patient comfort might seem out of reach for trial administrators. However, now is the perfect opportunity to maximize participant engagement by making these types of studies. They are inherently more convenient, and more comfortable through features like telehealth, and sensor and wearable integration. To realize the full potential of how wearables can increase comfort, they must fit into a patient's life, not be a deterrent to trial engagement. Understanding participants’ habits and preferences go a long way in personalizing the trial for them and ensuring technology is a help, not a hindrance. Instead of just asking a patient if they’ll wear a device, trial administrators can uncover questions or concerns that provide opportunities to optimize how wearables are deployed within the study design. In turn, patient data collected from these devices offer feedback immediately, allowing trial managers to alter appropriate study elements in real-time, make comfort improvements and increase retention metrics.

Hybrid and DCT research has the ability to make trials easier and more attractive to a wider population of possible participants. Patient engagement success requires careful consideration throughout the clinical trial lifecycle from design through closeout. Learn more in our latest whitepaper 6 Opportunities to Maximize Participant Engagement in Decentralized Trials that outlines best practices to enhance the patient experience through THREAD’s decentralized clinical trial platform.