The Power and Promise of Decentralized Trials
By Derk Arts, CEO, Castor | 06.25.21
Clinical researchers turned to a range of digital solutions to address the effects of the COVID-19 pandemic on trials.
The effect of COVID-19 has been enormous, with thousands of trials—around 80% of non-COVID-19 trials—being stopped or interrupted, according to Michael Lauer, deputy director for extramural research at the US National Institutes of Health. In addition, many high-risk and elderly groups stopped participation in clinical trials. In response, clinical researchers turned to a range of digital solutions to address the effects of the pandemic on trials. This in turn, accelerated the adoption of decentralized trials, including the digital health technologies such as wearables and other devices.
The World Health Organization (WHO) conducted one of the largest decentralized trials (DCT) to combat the largest pandemic in recent history to generate sufficient evidence of the efficacy and safety of potential treatments. The WHO’s Solidarity trial enrolled over 12,000 patients, involved over 2,100 investigators, and activated 553 sites across 30 countries. The trial has eliminated several investigative therapies, allowing for new contenders to be added.
The WHO Solidarity Trial is the world’s largest adaptive trial aiming to identify how existing medications might improve outcomes compared to standard of care alone. With more than 12,000 currently enrolled patients out of a planned 15,000, 2,145 investigators, and 553 sites across 30 countries currently participating, efficiently capturing and centralizing this data is critical.
According to the New England Journal of Medicine, “Launching and executing this ongoing trial is a remarkable achievement. The rapid, widespread enrollment is a testament to the commitment of the WHO and its partners, including Castor, and was enabled by a design that allowed, for each patient, the rapid collection, recording, and transmission of a small amount of high-information data. In 6 months, the trial team accumulated information on the collective experience of more than 11,000 hospitalized patients in settings with varied and evolving standards of care, capacity to administer treatment, and treatment options.”
DCTs enable the use of patient apps to help participants with e-consent and enroll, and complete electronic patient reported outcome measures and surveys. Telehealth platforms and online meetings with site investigators is key to increasing the reach of clinical trials for patients in remote areas. Especially for high-risk patients who can’t travel, and elderly patients, virtual consults replace in-person appointments, but patients can stay connected and engaged in the study. Safety is also key, so remote telehealth ensures that trial participants can be effectively monitored by the investigator, without compromising data quality.
Patients can also be assured that their study medication is provided at home even when they cannot visit the site. Patient compliance also increases, as individuals don’t have to travel and are staying safe and participating in a way that meets their needs. Another key aspect of DCTs are wearables and sensors, to support remote data collection directly from the patient. This can also enable real-time data capture, increasing data quality collected in the trial.
Although nobody can predict the future of post-COVID-19 clinical research, the shift toward greater adoption of DCTs will likely continue. Many regulators were quick to adapt guidance to accommodate DCT services. I believe this approach will continue, as companies see the evidence of significant benefits to patients, such as increased access to clinical trials and also remote telehealth monitoring. DCTs can also improve recruitment and retention, and accelerate drugs to market. More patients may request to participate in trials from home, now that decentralized trials are an option. It’s up to us to get this information out there to the public, so more individuals can participate in much-needed industry research.
Without clinical trials, no new therapies can be developed. With greater convenience for patients and reduced geographical, financial, and practical barriers to participation, the pandemic has pushed the industry toward swift adoption of DCTs. The pandemic has been a difficult experience for patients and sites in ways that nobody could have anticipated. However, with new forms of study designs and methods, people have adapted and thrived. With all that has been learned, it is likely that DCTs will be here to stay, long after COVID-19 is gone.
Derk Arts MD, PhD, founder and CEO of Castor, has over fifteen years of experience in medicine, research and technology. He founded Castor to solve the biggest issues in clinical research: a lack of inclusivity, patient focus and impact of data. Castor enables sponsors worldwide to run patient-centric trials on a unified platform, that helps them maximize the impact of research data on patient lives. Dr. Arts believes the key to achieving lasting change in the industry is through scalability and standardization. Technology to run better trials and maximize the impact of data should be available to all researchers. Over the past 12 months, Castor provided pro-bono support to over 300 COVID-19 trials, and provided the entire infrastructure for the World Health Organizations’ Solidarity Trials.