The COVID-19 pandemic is a challenge that is forcing us to reexamine how we do pretty much everything. There is no roadmap—just a barrage of mutable information. For those of us conducting clinical trials, the stakes are huge. Study disruptions put the time and resources already invested at risk and potentially delay the approval of new therapies. The safety of study patients—possibly the same patients those therapies are intended to benefit—is also at stake. This is especially critical for researchers in specialties such as nephrology, cardiology, and pulmonology, since these patients often have underlying conditions that may make them especially vulnerable to COVID-19. How do we continue advancing the science of new therapies while keeping study participants safe?
How will the new normal change your approach to reviewing protocols and sponsor requirements?
From social distancing and quarantines to business closures and travel bans, measures to prevent the spread of disease interfere with nearly every standard aspect of clinical trial conduct and protocol adherence. Fortunately, emergency U.S. Food and Drug Administration (FDA) guidance (Conduct of Clinical Trials of Medicinal Products During COVID-19 Pandemic) expands on allowable adaptations, such as virtual methodologies, and discusses procedural modifications, protocol amendments, and so on. Study strategies likely to become much more common include:
- Remote data collection methods: Alternatives to office visits for the collection of safety and other data have exploded. These include phone calls and video calls, home visits, and testing in external labs or imaging centers. The development and implementation of wearables, patient-reported outcomes, and the like will also likely accelerate.
- Remote patient enrollment models: Many trials are on hold now, but eventually, patient enrollment and study initiation will pick up. Video conferencing and remote testing are already being applied for enrollment and consenting activities.
Given the advantages many of these newer strategies offer sites in terms of efficiency and ease of enrollment, purposefully seeking out new trials that make use of them makes sense.
Embrace the possibility of taking a more active role in shaping the new normal for clinical trials. While protocol decisions are generally the responsibility of the sponsor, in our current predicament, sites have an important role to play in ideation/problem solving because they know the patients best and are on the front lines of study conduct. At the same time, institutional review boards are perhaps more open to novel means of allowing patients access to care and the potential benefits of investigational treatments. Investigative sites have much insight to offer—and much to gain—in developing the new normal for clinical trials.
Have you learned anything that could help you be better prepared for the next public health crisis?
The effects of COVID-19 have been far-reaching across the clinical research landscape. What have you learned? What can you do now that will help you be better able to respond effectively in the future?
One issue to consider is that life-saving treatments, even within clinical studies, must go on. Lack of physical access to patients and disruptions to the investigational product supply chain can interrupt treatment regimens. While sites can’t control supply chains, planned solutions such as remote administration and home health services for study drug infusion, or special delivery of oral study drugs with receipt witnessed by video conferencing, could help. Now is a good time to draft a new plan of action or incorporate what you’ve learned into an existing plan to address these concerns moving forward.
What happens when site personnel become ill or are pulled away to perform tasks deemed more critical?
FDA guidance related to the pandemic has loosened restrictions not only for how and where clinical trial care can be given, but also by whom. Sites should take the time now, while business may be slow, to assess contingency plans for substitute personnel. Arrange for alternate coverage ahead of time, whether that means cross-training personnel or bringing in medical partners who are not listed in the protocol. Update and write this into your policy now, while you have time.
Instituting so many adaptations has risk—take steps to safeguard data quality.
Even though current guidance seems more lenient, the number of possible clinical trial adaptations being made related to COVID-19 makes it especially imperative for investigators to keep clear and thorough records of exactly what was done, and why. This will help resolve questions that will, inevitably, arise as records are prepared for regulatory submissions. Especially where adaptations have been made because of the pandemic, sites should document what procedural changes have been made and why, in detail. They should also double-check with sponsors to ensure documentation is sufficient and complete, moving forward. Clinical trials have been disrupted enough; it’s more crucial than ever to ensure the usability of any data that are collected. Your sponsor will thank you for it.