Clinical trial success relies on enrolling and retaining the right patients. However, due to the growing number of global trials, the pool of potential subjects is becoming smaller, and there is increasing burden on sites to identify eligible patients for multiple studies.
In addition, patient drop-out and non-compliance with study protocols compromise data quality, extend study duration and increase costs. Engaging patients and/or their caregivers in the study is necessary for retention, particularly for select patient populations and therapeutic areas where frequent clinic visits are difficult.
Enrolling the Right Patients
It is not feasible to access historical data to determine eligibility for each individual patient. Therefore, a clear, up-front definition of patient eligibility criteria – including accurate, consistent measurements of those criteria – is critical during the enrollment process. The use of electronic enrollment, which is often based on validated, standardized tools and processes, reduces subjective eligibility assessments.
During the start-up period, electronic enrollment and its associated processes reduce both patient and site burden and can be tailored to the local environment and language ― engaging patients well before they even consent to participate. Then, because electronic enrollment is typically recorded directly in a centralized database, all enrollment data are available to easily track recruitment progress.
Keeping Patients in the Study
Once the right patients are enrolled, the next challenge is keeping them compliant with the study. This can be accomplished by designing assessments that are easy for patients to access, complete and submit electronically.
Leveraging electronic Clinical Outcome Assessment (eCOA) technology also enables sponsors to effectively share clear instructions and alerts on what to do and when to do it, with patient portals providing reminders, schedules and relevant educational content and training to keep patients engaged in the study. Research suggests that more than half (55 percent) of respondents strongly prefer electronic Patient Reported Outcome (ePRO) systems over paper diaries and that 86 percent “somewhat prefer” them.1
Data capture technologies for cardiac, diabetic, respiratory and other clinical measurements simplify patient participation. These direct-to-patient technologies, e.g., devices, activity meters and sensors, transmit clinical-grade data directly to a centralized database, making it easier for patients to submit their data throughout the trial. Even better, they eliminate data transcription errors and ensure data completeness, all of which improves data quality.
Check back soon for our final installment in the Clinical Site Optimization series, “Empower Sites to Do their Best,” and get caught up on earlier installments now: Identify the Most Historically-Productive Sites (Part 1) and Train Sites Effectively (Part 2).
Want to go deeper on this topic? Review “Four Easy Strategies for Clinical Site Optimization.”
Chris Neppes is the Product Manager of Site Optimization at ERT.
1. “EDC and eCOA/ePRO Market Dynamics and Service Provider Performance,” ISR, 2015.