The novel coronavirus (which causes COVID-19) has impacted every industry in one way or another—and clinical trials are no different. When it comes to executing these trials amidst a pandemic, sponsors are met with the challenge to think differently across all aspects of a trial’s operations—including but not limited to site visits and data collection—while ensuring patient safety and centricity remain top priority.
This has led to the accelerated implementation of decentralized solutions for clinical trials. Also referred to as virtual, remote or hybrid trials, these solutions provide a variety of benefits, including an improved patient experience, lower barriers to patient recruitment, increased patient retention and lower drop-out rates—and even higher data quality.
This article will discuss how sponsors can successfully adapt the decentralized model for trials operating during COVID-19, as well as the potential for these solutions to benefit and improve overall operations in the clinical research industry moving forward.
Conduct a thorough risk analysis
Before selecting and implementing decentralized solutions, sponsors must first establish the foundation of their new process via a formal risk analysis. A risk-based quality management (RBQM) framework offers early identification and evaluation of potential risks, monitoring of those risks and insights to help make adjustments throughout the trial period.
This process, paired with the leadership of an experienced contract research organization (CRO), will help determine the type of decentralized solution—either fully virtual or hybrid—and monitoring strategies that best fit the need of the trial. Overall, a fully realized RBQM approach is designed to focus on the aspects of the trial that are considered critical to the sponsor and for the overall purpose of the trial.
Maintain data integrity
Site operations is arguably one of the areas of clinical trial operations that has been most impacted by COVID-19. With participants more hesitant to visit study sites, sponsors must determine how to best conduct trials in a way that limits in-person interaction without compromising the collection of accurate data. A hybrid model offers the best solution for maintaining data integrity, as it still integrates the site component for data validation while allowing for some form of direct data capture to be done remotely.
However, sponsors must still consider the importance of medical oversight, even if some form of on-site visits are not able to be conducted. Every trial is complex in its own way, and having a principal investigator with protocol knowledge readily available helps keep patient safety top-of-mind.
Invest in customized technologies
COVID-19 has prompted the clinical research industry to actively pursue investments in customized technologies to transform the data collection process. The decision to invest in new technologies may be difficult; however, it is likely that the industry will continue to use them beyond the immediate impacts of the pandemic.
Sponsors should map out a strategy early in the process, which includes robust plans for site and patient training. Likewise, sponsors should ensure that the CROs they are working with have developed strong partnerships with any technology vendors they bring to the table. For example, at Rho we have implemented eCOA and ePRO solutions along with other devices and wearables to directly capture data from trial participants.
In addition to helping streamline the remote data collection process, these decentralized technology solutions also contribute to improving the patient experience, primarily by reducing the overall burden to patients, typically brought about by frequent travel time to on-site visits. Solutions like electronic diaries also help increase patient engagement, allowing for patients to keep record of their trial experience and receive reminders on their own devices.
Improve the patient experience
The patient must be the central focus of any decentralized solution. While the concept of improving the patient experience did not originate from COVID-19, the pandemic has certainly brought about an increased focus on patient safety and making the personal data collection process less cumbersome. This is best achieved by adopting solutions that are direct to patient (DTP), which minimizes the need for participants to go in for visits and take part in on-site procedures.
Additional patient-centric solutions include:
- Remote consent
- Remote recruitment and enrollment processes
- Telemedicine visits
- Home healthcare
- Lab draws
- DTP investigational product shipments
While decentralized solutions provide a variety of benefits, it is important to realize that these solutions are not one-size-fits-all. The right solution for a trial or program needs to be determined and managed using a robust RBQM process, and partnering with a CRO is critical in determining which solutions bring the most benefit to the trial. However, as site research conditions and patient availability continue to rapidly shift, these situations will continue to be uncertain for the foreseeable future.
The specific benefits these solutions provide will arguably drive the clinical research industry forward in innovation—even beyond the global pandemic. While there is no marked calendar date for when operations will return to what the industry once knew as “normal,” the current practice of conducting decentralized trials offers the opportunity to explore and implement new strategies that may prove to be the most effective options for future programs.
Marina Acosta Enslen is associate director of clinical management for Rho Inc., with 20 years of experience across Phase 1 through 4 studies. Prior to joining Rho, she has held positions in the areas of clinical monitoring, site-level study coordination, site start-up and clinical study management. She has extensive experience working on a variety of therapeutic areas, including HIV, oncology, acute pain and vaccines.