Investigator sites are critical study stakeholders and significantly contribute to trials that are on time, on budget and continue to progress through the approval pipeline. Providing sites with the resources and tools they need to effectively recruit and retain patients can go a long way to improving a company’s competitive edge. Here, we present the technological implementations that, if reached for early, can help trial sponsors get the most out of research sites and achieve significant cost, time and data quality benefits with minimal investment and disruption.
Identify the Most Productive Trial Sites: Benefit from Historical Data Across Multiple Sponsors
It’s often difficult and time-consuming to determine which sites are most likely to successfully enroll patients and provide timely, quality data. Considering that it costs $30,000 for site initiation alone and, on average, 30% of clinical trial patients drop out,1 a site’s ability to enroll and retain patients can significantly affect trial costs.
Many sponsors make site enrollment decisions based only on how a site has previously performed on their studies. But, today’s advanced solutions enable sponsors to make these important site selection decisions based on the site’s historical performance across all studies from numerous sponsors. With the right solution and technology partner, sponsors can rely on algorithms based on behavioral and performance data that score a site’s historical performance relative to other sites using criteria integral to each study, including patient enrollment, quality, operational efficiency and overall scores with indication and phase specificity.
In this manner, site-specific study data ― across all sponsors ― are stored in a centralized, cloud-based repository that can be accessed with proper credentials from anywhere at any time. The comprehensive data set shows which sites have a proven track record for enrollment and patient retention per therapeutic area, giving sponsors a better foundation from which to make informed site selection decisions.
Improve the Patient Experience through eCOA: Increase Enrollment and Patient Retention
Patient drop-out and non-compliance with the study protocol compromise data quality, extend study duration and increase costs. Enrolling and keeping patients engaged throughout the study is essential for retention, particularly for those with debilitating diseases where frequent clinic visits are difficult.
The use of electronic enrollment, which is often based on validated, standardized tools and processes, reduces subjective eligibility assessments, simplifying the enrollment experience and engaging patients well before they even consent to participate.
Once the right patients are enrolled, the next challenge is keeping them involved in the study for its duration. Making it easy for patients to access, complete and submit diaries can be accomplished through electronic clinical outcome assessments (eCOA). Through eCOA technology, sponsors can also effectively provide clear instructions and alerts on what to do and when to do it, with patient portals enabling reminders, schedules and relevant educational content and training to keep patients engaged and informed.
Empower Sites: Provide the Ability to Collect and Manage Patient Performance and Compliance Data Electronically
At best, paper-based data collection can provide clinical sites with preliminary study analysis within 60 days of study close. Whether the study has achieved appropriate statistical power cannot be learned until after all data have been processed, limiting the site’s ability to intervene if necessary to make sure that all data are coming in as expected. Even worse, patient safety may be at risk because safety signals must be observed at the site visit or reported by the patient – not two months later!
Electronic data capture expedites intervention decisions related to patient compliance or enhanced patient safety. Standardized and/or customized reports and alerts can notify site staff of non-compliant patients or missing data, empowering personnel to initiate appropriate remediation. This is an effective ― and efficient ― use of resources that essentially eliminates the middleman.
Driving change in any organization can seem daunting, but the approaches outlined here can be implemented with minimal, if any disruption. By applying practical, step-wise improvements, trial leaders stand to realize significant cost, time and data quality benefits that will continue to accrue over time.
Chris Neppes is Product Marketing Director, Respiratory, Imaging & Site Optimization at ERT
- Treweek, S. ‘Meeting the challenges of recruitment to multicentre, community-based, lifestyle-change trials: a case study of the BeWEL trial,’ 2013; 14: 436. Published online 2013 Dec 18. doi: 10.1186/1745-6215-14-436