Leveraging Mobile Technology in Clinical Trials

By Scott Gray, CEO, Clincierge
Twitter: @clincierge

Digital transformation within the healthcare industry has expanded rapidly throughout the past decade. The adoption of novel technologies has allowed providers to improve their internal processes, deliver more efficient care, and better meet the needs of patients in crisis. From the increasing popularity of telehealth appointments to advancements in wearable medical devices, possibilities for improvement through digital transformation are virtually endless, especially in regard to clinical research.

With the usage of smartphones at an all-time high in the United States, it is natural that mobile devices have become integrated into healthcare. According to the Pew Research Center, 97% of Americans own a cellphone of some kind, with 85% owning a smartphone. These statistics prove that many people depend on their smartphones daily to communicate, stay connected, and become informed. Pharmaceutical sponsors and clinical research organizations (CROs) can utilize these figures to validate that devices already owned by patients can help address some of the pressing issues frequently resulting in clinical trial delays.

Pain Points in Clinical Trials

From the initial study design to execution and completion, the clinical trial process is long, strenuous, and often riddled with obstacles for patients and trial staff. Patient recruitment and retention continue to be the most critical issues preventing successful, timely trials.

Research shows that two-thirds of clinical trials fail to enroll enough patients to conduct the study effectively, and 85% of trials fail to retain enough patients to complete the study. Even when an adequate number of patients are successfully enrolled, trial coordinators face an uphill battle in keeping patients engaged for the duration of the study. Dropout rates in these studies typically exceed 30%.

Trial delays are an unfortunate result of poor recruitment and retention rates. Only 6% of clinical trials finish on time, and 80% are delayed by at least one month. These delays have profound financial implications, causing the industry potential losses of between $600,000 and $8 million per day. The toll of these delays on humans, however, is immeasurable. Lengthy delays slow the researchers’ opportunity to bring new medications and treatments to the market faster and help those in need.

Considering the Patient’s Perspective

While the reasons for poor patient recruitment and retention are incredibly nuanced, the overall patient experience significantly influences participation. Understanding what creates a quality patient experience offers trial sponsors and CROs an advantage in today’s competitive drug development landscape.

In an independent survey by patient concierge service provider Clincierge, the majority of patients (87%) said participating in a trial was stressful for themselves or their families. This stress results from the various emotional, financial, and logistical burdens accompanying trial participation. In general, site staff and researchers focus on a trial’s medical and scientific facets, leaving patients, caregivers, and their families to manage the many tasks required for participation. The stress associated with coordinating travel to trial sites, handling appointments and follow-ups, and processing payment reimbursements often discourages patients from agreeing to this opportunity for much-needed treatment.

Mobile technology allows pharmaceutical sponsors and CROs to address these pain points by utilizing a medium which patients are already familiar with. These devices open the door for frictionless, bi-direction communication, which can greatly improve the overall patient experience. These technological advances are especially beneficial following the widespread shift to decentralized and hybrid trial models following the COVID-19 pandemic.

The Upside of Going Mobile

Improved Patient Engagement
Since site staff is occupied with keeping the trial in motion rather than catering to patient needs, participants are often burdened with the responsibility of navigating trial logistics on their own. In most cases, there is not one single point of contact available to address any questions or concerns that may arise throughout a trial.

Leveraging mobile devices to create a centralized platform allowing for bi-directional communication between patients and site staff can address this issue and help participants feel more supported. Allowing participants to manage and monitor all aspects of their clinical trial through a patient-facing portal benefits both individuals and site staff.

Participants can use a portal system to receive reminders about upcoming appointments, visit check-in times, medication alerts, and travel booking management. They can also contact site staff directly if a special request or pertinent question arises during the trial. This added layer of streamlined human-to-human interaction keeps site staff abreast of patient needs while providing an increased sense of support for participants.

Patient engagement is greatly improved, and higher retention rates result from a more positive patient-centric clinical trial experience. In essence, supported patients stay engaged.

Quicker Payment Processing
The out-of-pocket costs associated with a trial are a primary concern for potential participants. Although patients often receive reimbursement from the pharmaceutical sponsor for the money spent on travel, lodging, and other incidental charges, the reimbursement process can be long and complex, with 83% of patients in a recent study reporting it took 12+ weeks to receive a payment.

Automated payment processing and reimbursement managed through a patient portal can drastically improve the current status quo. This platform allows patients and caregivers to manage their study-related expenses via a web or mobile application. In practice, users can submit receipts, add mileage, edit expenses, select payment methods, and check payment statuses directly from their mobile device or computer.

This technology eliminates the burden placed on clinical site staff and puts money back into the participants’ pockets faster and more securely. Information is sent and received over secured servers, lowering the chance of human error or sharing of personal information. Patients can choose their preferred payment method, deciding on an option that is safest for them.

Better Data Collection
In addition to phones, other mobile technologies, such as wearable or embeddable devices, can aid in robust data collection. At the onset of COVID-19, pharmaceutical sponsors and CROs embraced quick digital transformations to ensure trials could continue and patient care would remain uninterrupted.

Hybrid trial structures utilizing in-person and remote patient monitoring prove devices like mobile health sensors allow for consistent, quantifiable data collection while offering more flexibility and comfort for the participant. These devices, combined with telemedicine, offer safe at-home solutions, resulting in reduced numbers of site visits and easier recruiting and trial retention. Similarly, cloud-based systems and artificial intelligence are streamlining data collection and significantly reducing time spent on data analysis, resulting in shorter, more robust trials and benefitting study sponsors and patients alike.

The Bottom Line

Tech-enabled innovation streamlines business services and empowers clinical trial teams to focus on providing excellent care to patients. Mobile technology allows pharmaceutical sponsors and CROs to utilize patient-owned devices to address the pressing issues resulting in frequent trial delays.

For the many benefits technology provides, it is important to remember they can be quickly overshadowed when reliance on technology feels like more of a hindrance than a source of support. A human touch will always be an essential part of clinical trial design, as patients going through the study process will continue to need emotional and logistical support.

As we continue developing and refining what it means to build greater patient-centricity into clinical trials, the overarching goal remains: selecting the most effective tools to improve the patient experience and deliver life-enhancing and lifesaving products to market faster.