Even before COVID-19, many business sectors were facing challenges to improve service and product delivery, and were beginning to explore the benefits of virtualization. The need to accelerate this trend has been particularly high in healthcare, where virtualizing clinical trials – using remote, patient-centered technologies – can help propel the research necessary to bring new medicines to market.
The COVID-19 pandemic continues to threaten public health and, in turn, the worldwide economy. The importance of discovering and developing new treatments and vaccines is obvious. But the novel coronavirus is also affecting advancements in other areas, ranging from Alzheimer’s disease to the Zika virus.
Because most clinical trials are conducted at physical study sites (a hospital, clinic, or doctor’s office), quarantines and limited access to healthcare facilities have created obstacles for patient volunteers to get to their checkups or enroll in new trials. Globally as of July 1, 2020, the average number of new patients entering trials year-over-year has declined by 6%. The impact is uneven, however, with trials down as little as 9% in France to declines of 55% in the UK and 79% in India. This trend threatens the development of new treatments while limiting patients’ access to experimental treatments that might improve, extend or save their lives.
Fortunately, the continuing digital transformation of life sciences offers new hope for overcoming these obstacles and discovering new treatments more quickly and more easily, with reduced barriers for researchers and patients. Part of this evolution aims to remove physical and geographical barriers that can interfere with launching a clinical study and carrying it to completion. Business innovation platforms, for example, have made it possible to manage multiple, divergent systems and technology for greater efficiency and economy. Best of all, these platforms make it easier for researchers to comply with all regulatory requirements.
RECOGNIZING THE BENEFITS
As a result, regulatory agencies are beginning to embrace technologies that enable the virtualization of clinical trials, as demonstrated by an analysis of 17 regulatory agencies’ practices around the world. Of four key technology areas surveyed – remote monitoring, e-consent, telemedicine, and direct shipment of investigational products to patients – all of the agencies have promoted at least two of the technology solutions; six of the agencies are advancing all four. Some have even indicated a willingness to extend emergency policies adopted during the COVID-19 pandemic, allowing the use of these innovations to become permanent.
These trends indicate that virtualized trials and direct patient interaction with technology are becoming more the norm rather than the exception.
Technology products, including mobile phones and wearable sensors, are continuing to virtualize more aspects of study design and data collection, including remote patient consent, treatment randomization, data capture, document monitoring and reporting, and site access. Cloud-based patient portals, meanwhile, are providing tools for study participants to talk with doctors, and also to share images and data related to their conditions. This same technology allows researchers to stay in close contact with study patients, monitor their conditions and collect a constant stream of data from both medical-grade and consumer devices.
These trends indicate that virtualized trials and direct patient interaction with technology are becoming more the norm than the exception. Beginning with the first partially virtual trial in 2001, about one-third of all clinical trials have already incorporated some form of virtualization, and the number of patients involved has more than doubled in the past few years.
CHANGE FOR GOOD
The adaptations the industry is making due to the COVID-19 pandemic will persist and grow, and will be supported by the next generation of analytical tools and AI algorithms. These are crucial to sifting through billions of data points to identify the evidence and insights necessary to demonstrate product safety and efficacy.
Rethinking and reengineering clinical development is revolutionizing the way we bring new therapies to patients, making trials more accurate, more efficient, and more patient-friendly than ever before.
PROFILE: Anthony Costello is Senior Vice President, Patient Cloud, at Medidata, where he oversees all patient-facing products and the mobile health business unit. During his 25 year history in the clinical research industry he has co-founded multiple start-up companies focused on clinical technology including Mytrus – acquired by Medidata in 2017.