As with the rest of the world, clinical trial sponsors and those that help facilitate trials have experienced unprecedented change over the last year as a result of the COVID-19 pandemic. At the beginning of the pandemic, when social distancing mandates were widespread and at their most strict, the industry was faced with many questions around the ability to continue studies or start new studies in an environment where patients’ ability to visit clinical trial sites was greatly reduced if not wholly eliminated. Restrictions on patients’ ability to visit trial sites and engage in face-to-face meetings with caregivers forced all of those involved in running trials to seek out ways to keep patients on track and engaged and be able to continue to gather useful endpoint data.
This has led to an acceleration in the adoption and use of remote patient engagement and monitoring technologies. Out of necessity, our industry has implemented these technologies over the past year, learning many lessons that will help to continue their critical therapy research throughout the pandemic, but also setting a foundation for future trials, post-COVID.
Lesson Learned #1: Patient Engagement
Keeping patients engaged and involved in a study is a challenge for sponsors and sites during ideal study conditions. In the past, much of the engagement work has been done through regularly scheduled in-person clinic visits. During these visits, site teams are tasked with gathering as much data pertinent to the study as possible. This can lead to lengthy and often frustrating visits, particularly if the patient’s record of participation in the care plan is incomplete.
Due to COVID-19, face-to-face interactions at healthcare facilities have been reduced. Study participants dealing with existing morbidities (and often multiple morbidities) are at a higher risk for severe complications should they contract the novel coronavirus. Understandably, these high-risk groups have been encouraged to stay home as much as possible. In order to keep patients from discontinuing their trial participation, technology has been employed to keep them engaged. Remote technologies ranging from telehealth to applications that run on smartphones or similar devices are helping study teams communicate with patients, monitor medication and care plan adherence and can provide a continuous stream of useful data on drug efficacy and safety.
These technologies show great promise for improving engagement and outcomes. For example, a recent study of diabetes patients showed that more frequent and regular participation via remote monitoring technology led to improved glycemic control outcomes.1 Additionally, these technologies remain with the patient 24/7. By monitoring each dosing, and through features like facial and voice recognition found in some applications, technology can provide study teams with real-time data on things like dosing adherence. This information gives new insight to study teams around what the patient is experiencing in the gaps between clinical visits. This is an important benefit of remote monitoring technology in normal study scenarios, but even more critical now that in-person visits are fewer, and farther between. Study teams can rely on this data to get the most benefit from face-to-face interactions and can save a great deal of time. Visits can be brief follow-ups with high-performing patients while more time can be allotted to those patients who need more help.
Lesson Learned #2: Quality of Data
Medication non-adherence is a major obstacle to running successful clinical studies. This sentiment is echoed in a recent article from the Journal of Clinical Pharmacology, which points out that not only is non-adherence common in clinical trials, but that it can lead to poor data, increased costs and studies that take longer to complete.2
The traditional model requiring scheduled face-to-face clinical visits relies heavily on patient recall or recording of dosing history, an approach that leaves a great deal of room for error and inconsistency. Thus, having a complete and accurate picture of dosing adherence can make a significant difference for any clinical study. Technologies can now be deployed that provide patients with alerts and reminders designed to prevent them from missing a dose. Some solutions go as far as to provide simple instructions on dosing correctly that also utilize a smart device’s video capabilities to record each dose. This provides study teams with constant confirmation of dosing through the technology – they no longer must count on patients to keep comprehensive paper diaries that leave room for errors. For this reason, the dosing data captured by the remote technology can be considered highly accurate.
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Research shows that the use of such engagement technologies can improve adherence rates. For example, a sleep apnea study published in CHEST reported robust adherence rates as a result of the use of modern patient engagement technology.3
Applying These Lessons to New Studies in the Post-COVID World
This necessary acceleration of technology adoption, particularly remote engagement technology, has shown that, not only is remote patient engagement and monitoring technology useful for trial continuity given today’s pandemic conditions, but that they possess the unique utility to help drive clinical trials in the future, postpandemic. The odds that the industry will return entirely to trial designs heavily reliant on in-person clinical visits seems low, as the benefits of using remote technologies look to outweigh whatever comfort level sponsors may have with older approaches.
Benefit 1: Patient Recruitment and Retention
In all phases of study, patient recruitment and retention can cause headaches for sponsors and sites alike. Dropouts, or failures to recruit enough patients (especially in early phases) can cause lengthy delays and prove extremely costly. Common recruitment and retention obstacles include patients’ financial barriers, logistical concerns, the lack of resources for patients and clinicians and even a study’s own restrictive eligibility criteria.4 Overcoming these obstacles can improve a study’s chances for success and significantly speed up a trial.
Technology is now available that helps to identify and screen potential study candidates. This technology records a variety of patient characteristics that can be captured with a smart device and then analyzes that data to help predict which candidates are likely to be high performers, meaning they will be more likely to show high dosing adherence and less likely to drop out of a given study. Starting a trial with an optimized patient cohort greatly increases the likelihood of getting better data.
Aside from using technology to build predictive models of cohort success, it is important to build a plan for how study teams will communicate with patients via technology. Focusing on the patient early has clear benefits that affect a study’s potential success. For instance, a recent article published in Health Affairs showed that having a clear plan for how caregivers will communicate with patients throughout the trial and sharing that plan with potential study candidates increased enrollment from 65% to 95%.5
Benefit 2: Patient Engagement
Once the patient pool is set, remote technology can be utilized to optimize their performance. With a smart device that they already own, or one that is supplied by the study owners, patients can take advantage of a virtual assistant that is available to them 24/7, seven days a week. This kind of technology can guide the patients through dosing, sending them alerts and reminders to ensure doses are not missed. Doses can also be recorded in real time, with assistance from advanced artificial intelligence that confirms correct dosage. The study team then receives full visibility into dosing adherence across the patient pool, allowing them to track performance and identify potential issues with patients quickly. Study teams can engage remotely, via technology, with patients to help solve problems. Patients feel supported through the ease of interacting with caregivers, while the caregivers on the study team can solve problems or prevent them entirely through simple and early interventions via the remote technology.
Benefit 3: Easing Patient and Site Burden
The use of remote engagement and monitoring technology has the potential to ease stress on patients, leading to better adherence and overall study performance. Therapy regimens associated with clinical trials can be complex. It can be a lot of additional work for patients who are dealing with one or more illnesses while simultaneously managing their careers and families. With a technology partner in the palms of their hands, patients may have an easier time staying on track with their trial responsibilities.
For the study team and sites, remote technology means they no longer must rely solely on what they can glean from intermittent clinical visits with patients. They can now have full visibility of patient behavior, 24/7. This enables them to provide the right level of support for patients and get the most out of necessary clinical visits. Patients that might need a little more help and oversight can have more time with their clinical providers, while patients that have been extremely on task can get in and out. Always-on remote technology can provide the study teams with a wealth of data on each patient, so that when the patient does come into the clinic, time is not wasted and caregivers can focus on higher value interactions versus spending time asking basic questions around things like dosing.
Conclusion
COVID-19 has changed the way many live their lives and do their jobs, but there are some unforeseen benefits. Just as many industries are discovering that productivity and success can be achieved with a largely remote workforce, we in the clinical trials space are seeing benefits to adopting and implementing remote technologies. While the acceleration of remote technology adoption may have arisen from a concern over keeping trials moving, or being able to start new trials during the pandemic, numerous benefits of these technologies have been observed that will continue to be utilized in the future after the pandemic ends. Remote patient engagement and monitoring technology has clear advantages to patient engagement, recruitment, retention and data quality. These technologies promise to complement the important work study teams do in face-to-face visits while simultaneously improving the value of those visits through the provision of 24/7 patient data, allowing study teams to focus on key issues versus basic data collection. Increasing patient engagement through remote technologies has measurable impact on medication adherence and through this can improve the quality of data in clinical studies overall.
References
- Dejun Su, Tzeyu L. Michaud, Paul Estabrooks, Robert J. Schwab, Leslie A. Eiland, Geri Hansen, Mary DeVany, Donglan Zhang, Yan Li, José A. Pagán, and Mohammad Siahpush. Telemedicine and e-Health.Oct 2019.952-959.
- Shiovitz TM, Bain EE, McCann DJ, et al. Mitigating the effects of nonadherence in clinical trials. J Clin Pharmacol 2016; 56(9): 1151–1164.
- Malhotra, et al. Patient Engagement Using New Technology to Improve Adherence to Positive Airway Pressure Therapy: A Retrospective Analysis. CHEST. Volume 153, Issue 4, April 2018, Pages 843-850
- Nipp, et al. Overcoming Barriers to Clinical Trial Enrollment. American Society of Clinical Oncology Educational Book 39 (May 17, 2019) 105-114.
- Forsythe, et al. Patient Engagement In Research: Early Findings From The Patient-Centered Outcomes Research Institute. Health Affairs Vol. 38, No. 4. March 2019