The world has seemingly changed overnight. We are living in a historical moment, thanks to a microscopic foe known as COVID-19. As you are reading this, you are likely working remotely, and you may—or may not!—be anxiously waiting to get back into the office once “normal” operations resume. Or, you might be one of the brave people on the front lines, trying to keep the earth rotating on its axis while the rest of us hunker down.
Our medical professionals, particularly those in hospitals, had to adjust overnight to a new way of supporting the welfare of patients. Established pandemic protocols were dusted off, detailing the proper usage of masks and gloves—both of which quickly ran into low supply across the world—and how to prioritize in-facility patient treatment. These healthcare professionals also had to move swiftly into a virtual method for patient care, spending long hours on telemedicine shifts and finding creative ways to evaluate, and eventually treat, patients from their homes.
The clinical research industry has dabbled in the virtual space for some time now, cherry-picking low-priority studies to test artificial intelligence platforms and home healthcare nursing options. Our protocols are still designed around traditional, in-office visit expectations and methods for data collection and query resolution. But today we find ourselves squarely facing the impossibility of continuing as we always have—as with the front-line healthcare professionals, we have to adapt immediately to a virtual environment to protect the well-being of research subjects.
At this year’s SCOPE 2020 conference (only one short month ago!), pharma, biotech, and medical device professionals gathered and listened to panels where virtual and decentralized trials were discussed. We evaluated the Gartner Hype cycle for adaptation to virtual study conduct, agreeing that such possibilities are five-to-ten years away due to logistics and regulatory considerations. Yet here we are today, only a few weeks later, in the midst of a pandemic and actively converting our concepts into practice. We are driven by a dual responsibility: protecting the welfare of patients actively participating in clinical trials and developing new therapies and vaccines to protect against COVID-19.
Our regulatory agencies are supporting us in this effort. In March, the FDA released a guidance document on “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.” It outlines ways for sponsors, investigators, and IRBs to protect study subjects, families, and caregivers during this pandemic. It also allows for expedited protocol amendments in order to incorporate safety mechanisms, at-home IP administration, and virtual data collection methods. This FDA guidance is an acknowledgment that we do not have all of the answers today, and we need to quickly innovate together. Sample questions we are all asking ourselves—and our regulatory departments—are included in the guidance appendix:
What are some of the key factors that a sponsor should consider when deciding whether to suspend or continue an ongoing study or to initiate a new study during the COVID-19 pandemic?
How should sponsors manage protocol deviations and amendments to ongoing trials during the COVID-19 pandemic?
If patients are currently dispensed investigational product through a pharmacy for self-administration at home, can a sponsor switch that to home delivery without amending the protocol?
How do I obtain a signed informed consent from a patient who is in isolation and the COVID-19 infection control policy would prevent us from removing a document signed by the patient from their hospital room?
These questions come from an industry that depends on in-person, in-office research environments. Fortunately, we have the benefit of many technology providers in our industry who, for 10+ years, have been evolving their platforms and tools, nudging us into a more virtual clinical research world. Yesterday we scrutinized these options as cutting-edge, nice-to-have features; today and tomorrow, we will rely on these as the only way to move forward. From site identification and activation, through subject consenting, IP administration, and monitoring, and into data collection and study closeout—e-clinical technologies exist today, supporting all of these activities and patiently addressing the questions raised in the FDA guidance.
Let’s do our part to support the many nurses, doctors, and healthcare providers who are quickly adapting their in-person treatment practices by evolving the future of the healthcare industry into an environment that’s safer for them and for patients. We can take comfort that decades of innovation exists and places us in a world where we have the technology to help us adapt. This moment also allows us to ponder a world that operates a little differently. A little more virtually. One that is more efficient and more accessible. In the meantime, we are not helpless—though it may very much feel like that sometimes. Together, we have the tools to make a rapid change and find a path forward.
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