Digital technologies may have the best opportunity to change how trials are conducted for years to come.
Daniel Piekarz, SVP of Life Sciences & Healthcare, DataArt
The rapidly evolving threat around the coronavirus disease 2019 (COVID-19) outbreak is impacting lives, communities, businesses, and industries across the world. With the high severity and more significant contagion effect, this pandemic has already negatively influenced the current ecosystem of clinical trials as a whole. New trials have essentially stopped in most areas except COVID-19, and quickly finding patients for COVID-19 trials is an interesting dilemma.
The consequences of the pandemic on the conduct of clinical trials are many, and include:
The costly implications reach far and wide as current clinical trials have been delayed, temporarily halted, and in some cases, will need to be completely redone. As a result, many experts are pointing to digital health technology as a potential solution. The effect of this pandemic could inadvertently transform the future and fast forward the move to virtual trials and telehealth.On March 18, the FDA issued guidance for industry, investigators, and institutional review boards as it relates to the execution of clinical trials during this public health emergency. The recently updated guidelines provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the pandemic.
As part of the guidelines, the FDA acknowledges that there may be an increase in protocol deviations during the COVID-19 pandemic and suggests that monitoring activities may be re-assessed to ensure participant safety, citing phone contact, virtual visits via telemedicine, or alternative care sites as options.
Clearly, sponsors and investigators will need to validate whether these alternative methods are feasible and aligned with the study protocol. Still, such possibilities could lead to better outcomes—speeding up the process, reducing participant risk or attrition, and significantly decreasing costs associated with the trials.Remote patient monitoring, home care, and telehealth have been gaining momentum as a healthcare offering, but it would seem that COVID-19 has added more horsepower to this initiative.
The Federal Communications Commission (FCC) has voted to adopt a $200 million telehealth program to support healthcare providers responding to the ongoing coronavirus pandemic, and the Centers for Medicare & Medicaid Services has allowed new flexibility in the use of telehealth. Walgreens just announced the expansion of its telehealth program to include a COVID-19 risk assessment, information on clinical trials, and a higher number of providers. And, according to a recent Spyglass Consulting report, 88% of hospitals and health systems have invested in or plan to invest in remote patient monitoring technologies.
However, when it comes to the clinical trial space, can organizations pivot quickly enough to digital and remote site monitoring for pharma? Will the disruption of COVID-19 lead to a lasting transformation of digital technologies into study design, implementation, and management?
In 2019, National Academies of Sciences, Engineering, and Medicine convened a workshop to study the current clinical trials system and examine the potential benefits and challenges of implementing virtual clinical trials. The general sentiment was that the current model for clinical trials was becoming more expensive, inefficient, and inaccessible over time. The panel of experts also agreed there was an urgent need for the next generation of clinical trials to incorporate new technologies.Over the years, clinical trials have grown in volume and complexity, playing a vital role in the research and development of new drugs and products. ClinicalTrials.gov currently lists 335,576 studies with locations in all 50 states and in 210 countries. This is a significant increase from the 2119 that were registered in 2000.
The landscape of clinical trials continues to evolve as scientific breakthroughs and technological innovations emerge. The ongoing advancements in cloud, mobile, and IoT, combined with video conferencing and wearables, are opening up unprecedented opportunities for pharma and healthcare, bringing about the evolution of clinical trial management. From recruitment to submission, hybrid and virtual clinical trials and digital healthcare will likely become the ‘new normal’ post-COVID-19.
There are countless benefits to virtual trials, both short-term during the contagion and long-term, to help shape the future of the industry. Virtual visits and remote patient monitoring in place of mandated in-person site visits gives trial participants a choice as well as the added peace of mind that they won’t be exposed to unnecessary risks. Virtual visits allow sponsors to reach a larger population of participants improving subject recruitment, engagement, and retention.
When it comes to analytics, insights collected through digital health technologies enable continuous real-time data collection. Ultimately, virtual connectivity, monitoring, and management can greatly reduce the time commitment, effort, and burden on the investigators, CRCs, and participants.
With resources and priorities diverted to defeat the pandemic, it is unclear what will happen since there is no precedent. With the clinical trial ecosystem mostly at a standstill, the emergence of digital and virtual technology may have the best opportunity to succeed right now and change how trials are conducted for years to come.
Daniel Piekarz is the senior vice president of Life Sciences & Healthcare at DataArt, focusing on servicing Pharmaceutical and Healthcare organizations. The presented analysis reflects his views, not necessarily those of the publication.
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