Clinical trials are trying, even in normal times. The global pandemic has created a world of issues that exacerbate an already complex and inordinately long process. It has fueled massive disruptions that will inevitably have long-lasting effects on medical science.
As with life in general, the virus has severely affected the ability to conduct trials in safe and effective ways. An especially troubling fact when you consider that trials often deal with those vulnerable populations most at risk from exposure.
Thousands of trials have been suspended or stopped due to difficulties in continuing under ever-changing and restrictive conditions. Distrust and safety concerns among patients are at unprecedented levels. Physical distancing to protect them, as well as clinical staff, is paramount.
Non-COVID-19 clinical trials down 80% due to the pandemic
The Tufts Center for the Study of Drug Development interviewed 25 organizations which revealed the following troubling statistics on the impact of the virus on clinical trials:
- 25% were behind in trial enrollment
- 48% halted trials for at least one month
- 92% reported medium-to-high impact on ongoing trials
- 76% adopted some form of telehealth for routine follow-ups
The move to Decentralized Clinical Trials
Terms for decentralized trials include virtual, hybrid, home, remote, and site-less. While the terms might differ, the goal is the same: making clinical trials easier for patients through reducing or eliminating the need to travel to specific clinical sites. This approach has promised to reduce dropout rates, increase study effectiveness, and reduce time-to-market, potentially saving sponsors billions. Importantly, it also promises to help increase participant diversity: bringing the trial to the patient in their home has helped to engage and enroll those patients who might not have ordinarily participated due to access issues. “Decentralized” doesn’t necessarily mean that trials are conducted without healthcare professionals, however – the need for physical conduct is not completely eliminated (in most cases). But in the COVID-19 era, reducing the amount of physical contact is crucial. In this way, decentralization might be considered the epitome of a patient-centered approach to clinical trial design.
Wearable technologies becoming central to decentralized trials
The first wearable computer was invented in the late 1970s. Today, wearable technologies are ubiquitous and include smartwatches, fitness tracking bands, smart glasses, smart clothing, and more. The increasing use of such remote monitoring technologies in clinical trial design has helped to bring real-world data into play, providing early indications of adverse events and more accurate tracking of participant adherence to clinical trial protocols, which in turn has helped to reduce cost and improve trial efficacy. All while adhering to the most stringent COVID-19 protocols.
Bridging the gap between physical and virtual care
One company looking to disrupt the Decentralized Trials space is Seattle-based Hippo Technologies, Inc., whose Hippo Virtual Care (HVC) platform is helping healthcare providers and educators overcome time, distance, and training barriers during COVID-19. The platform includes a head-mounted, voice activated headset providing a “through the eyes of the user” experience, delivering all the benefits of an in-person experience with the safety and convenience of remote care.
According to Dr. Patrick Quinlan, CEO and Co-founder, “In a Decentralized Clinical Trial scenario, Hippo enables specialist care to be delivered in the home without the specialist having to leave the hospital. A nurse or social worker can visit the patient and can orient them for remote examination in a way that conventional telehealth via a smartphone or tablet doesn’t allow.” For example, a CRO is conducting a Phase 3 clinical trial for a cancer therapeutic. Normally, this would require the patient to attend a weekly in-clinic visit to get examined by a specialist, potentially exposing them to COVID-19 or other diseases. Using Hippo, a nurse equipped with a Virtual Care headset visits a patient at home, while the patient is seen by the specialist remotely.
The growing problem of patient drop-out can also be addressed. “On average, one in five patients drop out of clinical trials,” explained Dr. Quinlan. “The main reasons often cited include inconvenient site location, or they are physically unable to attend appointments, plus there’s understandable fear and anxiety of going to a clinic during a pandemic. Hippo effectively overcomes these challenges and more.”
Long heralded as the answer to the complexity and cost challenges that have plagued clinical trials for decades, emerging technologies are at last realizing their true potential, thanks to the global pandemic. Decentralized Clinical Trials are here to stay, and solutions like Hippo are helping to make them safer and more convenient for patients, more efficient for clinical site staff, and more cost effective for sponsors.