Virtualizing Clinical Trials And COVID-19: Why Digitization And Connectivity Are More Important Than Ever In Treating Disease
By Glen de Vries
As the COVID-19 pandemic persists, every industry is working to pivot and adapt. In many respects, an effective vaccine will mean a return to business as usual. In healthcare and life sciences, it will not, nor should it.
Among the wake-up calls this coronavirus has sounded is the need to transform the way we conduct clinical trials and utilize the resulting data. The pandemic has exposed limitations in the clinical trial process that have had repercussions not only in the development of drugs, but also in how we might have been better prepared to face this pandemic head on.
Many clinical trials effectively shut down, or at least slowed down, because of the pandemic. The simple truth is, even in 2020, there is a huge dependence on the physical colocation of the patient and caregiver; patients need to visit an office or a clinic. Because of social distancing requirements, we’re now seeing strong interest in using technology to connect these parties. As clinical trials are being virtualized, a patient can get blood drawn at a nearby mini clinic or a nurse practitioner may come to the house to do evaluations. Patients can track their symptoms in an app and sensors can relay mountains of data wirelessly. The barriers are disappearing; the patient and doctor don’t need to be in the same place.
Conducting a trial virtually may have seemed unnatural before, but COVID-19 has transformed our expectations. We now live in a world where so many of our interactions are virtual, both personal and professional. Healthcare has already begun shifting to telemedicine, and that is cascading into clinical trials. For example, one of the most difficult aspects of a clinical trial is getting the patient to the site, so anything that can be done to lower the burden on the patient, to make the job of being the investigator that much more scalable, is a huge asset. Moving forward, clinical trials that use digital connectivity between the patient and physician will help trailblaze the future of telemedicine. Beyond a teleconference between a doctor and a patient as a necessity or a luxury, to something inherently imbedded in the way therapies are designed and delivered.
Moving toward virtual trials enables the process to proceed without external interruption, but it also allows for better data aggregation and analysis. With these new technologies, we can see the progression of a disease or response to a drug in real-time. Gathering large amounts of diverse data can help us see immediately what is happening with potentially epidemic or pandemic agents, and perhaps contain, treat, or even avoid their spread.
Tremendous amounts of health information — medical histories, blood chemistries, medical images, genomic data, cognitive scores, etc. — have been collected in clinical trials and are sitting in databases all over the world. Unfortunately, there are few ways to connect them. This represents a potentially life-saving opportunity. If we had seen that this global pandemic would run through a population of patients like those who have volunteered to be in trials, we could have had an impact early on. If we could have put high quality, curated data in one comprehensive place to examine the variables around these patients who are getting sick, we could have possibly known a lot more about the nature of the virus. What happened to these patients before? What was their BMI? What other conditions might this virus cause? This type of comprehensive data is something I highlight in The Patient Equation as an integral part of delivering precision medicine. Rather than assessing one variable at a time, we should be examining all the ways in which this complex data, seemingly pertinent or not, is needed to accurately treat a patient. It’s about seeing the entire forest, rather than one tree at a time; seeing all the attributes of a potential COVID-19 patient, rather than just age and immune status.
While I recognize that compiling this massive amount of data is not easy, I do believe it is possible. With advancements in digitization and connectivity, particularly as we increasingly virtualize clinical trials, we can do a better job in everything from rare diseases to diabetes to oncology and beyond. If we can leverage these collective data assets, the response to the next pandemic, whether it's 10 years from now or 100, will naturally be better.
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Glen de Vries is co-founder and co-CEO of Medidata. He is the author of The Patient Equation: The Precision Medicine Revolution in the Age of COVID-19 and Beyond, to be released September 16, 2020.