Article contributed by: Ed Ikeguchi, CEO AiCure
The jobs of study sites in clinical research are difficult. Keeping patients engaged throughout the course of a trial is always challenging, particularly now during the COVID-19 pandemic. While numerous remote technologies exist to facilitate virtual patient visits or to monitor patient’s medication adherence and symptoms, they cannot replace the critical role of site clinicians and study managers. The personal connection developed between site teams and patients is vital to study success, as it provides a tangible tether of support that maintains buy-in from patients and keeps them on task.
Remote technologies, including digital biomarkers and medication adherence solutions, are best used as complements to the work being done by sites, reducing their burden and providing patients with new channels for engagement.
Enhancing Visibility With Digital Biomarkers
Digital biomarkers hold great promise to enhance the objectivity, sensitivity, and frequency of assessments in clinical trials. Digital biomarkers consist of physical or behavioral patient data collected and measured via medical devices such as portables, wearables, implantables or digestibles, or common devices such as smartphones or tablets. They are particularly useful for measuring patient data that would be difficult or even impossible for human observers alone to detect. Innovations that have made it possible to measure digital biomarkers via the patients’ own smart devices have increased accessibility, and tech-savvy sites are realizing the benefits of this. While traditional studies would have clinicians rely on patient recall of their experiences, with digital biomarkers, changes to patient symptomatology can be shared in real-time with clinical study teams. Digital biomarker technology gives the study team data they can be confident in, allowing them to spend less time during visits trying to complete a picture of patient activity between visits and more time providing support and guidance to patients, while also helping to ensure the integrity of clinical trial data throughout a study’s duration.
For patients with neurological disorders, digital biomarkers can make a significant difference in measuring their response to treatment as well as identifying any potential adverse events. Digital biomarkers are particularly adept when tracking symptoms such as tremors, facial paralysis or symptoms of any disease which would cause alterations in facial or vocal affect. Patients with Alzheimer’s Disease, for example, can often present extremely subtle symptoms, which can be difficult to pinpoint in clinical visits. Therefore, it is critical for those developing new therapies for Alzheimer’s Disease to have a way of detecting even the slightest changes in cognitive ability in order to produce valuable safety and efficacy data.
However, despite the potential that scientifically validated digital biomarkers hold to enhancing clinical trials, this method of measuring patient behavior has not yet been fully maximized, as proprietary machine learning models are typically not accessible to scientists to independently evaluate. Breaking down these barriers and expanding access to these emerging approaches to remote patient assessment through open-science frameworks will be key to advancing their development and use. This will ultimately deepen the pool of clinical data available to interpret study findings, and better equip sites to offer patients the support they need.
Using Technology to Improve Medication Adherence
In order for clinical studies to be successful, patients need to have a solid understanding of their responsibilities, the most important of which is taking their medications correctly. Even a small group of patients failing to comply with their medication regimen can jeopardize the integrity of study data. Non-adherence, unfortunately, is quite common, with clinical studies often seeing rates of up to 50% of patients who are non-compliant. Non-adherence occurs for a variety of reasons. Patients and their caregivers are under a great deal of stress. They are participating in a clinical trial, most often, because they are sick. On top of this illness, most patients are working, they have family responsibilities and it is common for them to have other health issues outside of the concern that brought them to the clinical trial.
Keeping large cohorts of patients adherent to their medication regimens commands a great deal of time and attention from study teams. Similar to the digital biomarker solutions, study teams can deploy technologies that allow patients to engage with them via smartphone applications on devices they already own to support adherence. These apps can send reminders to the patients when it is time to take their dose, a simple functionality that can lead to significant improvements in adherence, particularly with patients who have diseases that affect memory such as Alzheimer’s or Parkinson’s Disease. Furthermore, remote engagement technology can provide step-by-step guidance using visuals or even short videos, so patients can follow along and feel confident that they have taken their medication correctly. Some applications also use the device’s video recording capability to confirm that the dose has been swallowed or otherwise administered correctly, and then share that information with study teams. By notifying site clinicians if there are problems with dosing adherence, they can engage with patients through the application to provide support and solutions that get the patient back on track.
Empowering Patient-Centric Trials with Technology
With COVID-19 keeping more patients than usual away from clinics, study teams are looking for solutions that help them stay engaged with their patients while maintaining a pipeline of quality data. Technology can complement the important roles of the study clinicians and augment their ability to track patient compliance and gather dosing and symptom data, particularly from the times between in-person visits. By using remote engagement, monitoring and measurement technologies to improve medication adherence and quickly identify changes in symptoms, site clinicians can focus their efforts on critical tasks such as providing individualized support for patients who need it and evaluating data.
 Mitigating the Effects of Nonadherence in Clinical Trials Thomas M. Shiovitz, Earle E. Bain, David J. McCann, Phil Skolnick, Thomas Laughren, Adam Hanina, Daniel Burch J Clin Pharmacol. 2016 Sep; 56(9): 1151–1164. Published online 2016 Jan 22. doi: 10.1002/jcph.689
 Vervloet M, van Dijk L, Santen-Reestman J, van Vlijmen B, van Wingerden P, Bouvy ML, et al. SMS reminders improve adherence to oral medication in type 2 diabetes patients who are real time electronically monitored. Int J Med Inform 2012 Sep;81(9):594-604