What is the future of virtual clinical trials?

By Jeff Morgan, managing director, and Suyash Nigam, manager, Deloitte Consulting LLP

Clinical trials have undergone some significant changes over the past two and a half years. While decentralized clinical trials (DCTs) and virtual trials (VTs) have been embraced by pharmaceutical manufacturers, patients, and investigators, they are still in their infancy. Multiple barriers will likely need to be overcome before they can reach their potential. DCTs and VTs are generally defined as clinical studies that use telemedicine and digital health technologies to conduct some or all trial activities outside of traditional trial sites.

Prior to joining Deloitte, Suyash worked with a team at a large pharmaceutical manufacturer that was exploring ways to make clinical trials more patient-centric. He and his team explored the technologies, processes, regulations, and participant perceptions that limited the success of some early virtual trials.

Clinical trials have historically been conducted at brick-and-mortar research facilities, such as research hospitals and clinics. Traditional study protocols require participants to be on-site for all trial-related activities. This model typically requires participants to travel to clinical trial sites, which are often located in urban locations. Such locations can exclude rural and low-income patients who might be unable to travel to a clinical site or might not be able to take time off work or find childcare. As our colleague Dawn Anderson noted in her blog, this can negatively impact recruitment and retention (see Retail clinics may be the next frontier for clinical trials). DCTs and VTs can help overcome both of those barriers.

COVID-19 may have forever altered clinical trials

In the spring of 2020, as COVID-19 restrictions were being put into place, an estimated 6,000 clinical trials were underway.¹ Lockdowns, restrictions on movement, and a reluctance to travel made it difficult to recruit and retain clinical-trial participants. In the absence of any virtual monitoring, investigators had no way of checking the health and wellbeing of their study participants. Many sites did not have systems for managing schedules, logistics, or procedures for dispatching medicines to the patient’s home. Moreover, some clinical sites closed their doors or were severely understaffed for trials.

In response, many pharmaceutical companies made investments in virtual clinical trials because they had a financial stake in keeping their clinical trials moving forward. Some patients used mobile apps to complete surveys and other types of data collection. While sensors, apps, and other remote tools can make it easier for patients to participate in clinical trials, not everything can be done remotely. Blood samples, for example, and various tests cannot be done remotely. In some cases, a nurse might be sent to the participant’s home to draw blood and conduct tests. This could create a need to combine onsite capabilities with virtual capabilities in a hybrid clinical-trial model.

Benefits of DCTs and VTs

Decentralized and virtual clinical trials promise significant benefits to patients, pharmaceutical companies, and clinical trial sponsors. A patient’s entire journey in a clinical trial can be made virtual and more inclusive using technology. Some key benefits include:

• Remote screening/consent using mobile and web-based applications.
• Use of electronic Patient Reported Outcome (ePRO) diaries for remote recording of patient outcomes.
• Medication adherence and compliance through use of app-based notifications and gamification-based compliance strategies.
• Use of specialized sensors and wearables for remote monitoring and compliance.
• Mobile nursing where nurses travel to the participant’s home for certain aspects of the trial (e.g., blood-sample collection).
• Remote consultations using tele-visit capabilities.

Where are virtual trials headed?

The VT space has rapidly evolved since the COVID-19 pandemic emerged. With new technology vendors entering the space, and existing vendors enhancing their product offerings, there has been significant upgrade in technology and process offerings. Many of the legacy solutions were focused on single capability within DCT (e.g., eConsent, ePRO, gamification). Today we are seeing increased emphasis on end-to-end platform solutions where each provider offers a complete suite of DCT capabilities.

Even with some of the innovations we have witnessed over the last couple of years, clinical trials continue to be refined to capture more meaningful insights from trial participants. Some of the ongoing areas of innovation include:

• Integrated platform with plug-and-play services: Some technology-solution providers now offer a complete suite of DCT capabilities within a single platform (e.g., consent, ePRO, surveys, tele-visit). These services can typically be customized to the trial’s protocol requirements and can usually be deployed quickly. Offering plug-and-play capabilities could help trial sponsors quickly enable only the capabilities that are required by the study protocol. Cloud-based services could allow the DCT capabilities to be available globally. This technology could lead to faster analyses of participant metrics.
• Medical device integration: Patient monitoring is no longer restricted to in-clinic assessments. Wearable sensors and remote monitoring devices can be used to track patient vitals. These tools can also generate real world data (RWD) that can help improve the quality of data generated during a trial. While specialized wearables are still used for critical trials, some commercially available fitness trackers and smart watches are beginning to capture clinical-grade data. These devices create an opportunity to gather valuable participant metrics in real time, and at a low cost to sponsors.
• Remote sample collection: The need to collect samples from trial participants is often perceived as a barrier to DCTs. However, advances in integration between DCT systems and courier-service providers presents an opportunity for participants to collect samples at home and have them transported to the clinical trial site. A mobile app, for example, could notify in-home providers to collect a sample based on protocol schedule and/or a patient’s request. The same app might also be used to track the collection and transport of the sample.
• Smarter drug deliveries: Transportation innovations are making it possible to ensure drugs are delivered to the participant’s home quickly and in the required climatic conditions. Technology can also be used to monitor the entire supply chain. Automated notifications can be triggered when drugs are received by the participant. Smart dispensing bottle caps could be used to ensure that only the required dose is dispensed at required interval with proper data-logging capability.
• Gamification and patient reimbursement: Compliance with trial milestones is often one of the biggest challenges in clinical trials. Gamification has been shown to improve patient retention in clinical trials. Gamification can provide an incentive for participants to adhere to the trial protocols and to reach trial milestones. In addition, prompt reimbursement can help ensure that participants are rewarded for their time and effort. Linking various gamification measures to rewards and reimbursement can ensure quicker payments upon completion of milestones. It also can result in a higher compliance and adherence rate for clinical trials.

Conclusion

DCTs and VTs could be the future of clinical trials. They offer tremendous benefits to patients as well as trial sponsors. Late last year, the Food and Drug Administration (FDA) requested comments on their guidance regarding data capture using remote technologies. In response, many trial sponsors and Contract Research Organizations (CROs) have been working to incorporate digital technologies into existing trials. DCTs and VTs represent a viable and potentially more patient-centric solution option to traditional clinical trials. The future of virtual clinical trials is bright given the ongoing advances in remote monitoring tools, improving data collection technologies, new patient-engagement platforms, ever-improving wearable devices and digital biomarkers, and the roll out of 5G (see What’s the Big Deal With 5G Anyway?).

Endnote:

¹ Clinical trials are moving out of the lab and into people’s homes, New York Times, February 18, 2021

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