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Subspecialties COVID-19, Basic & Translational Research

Trials, Interrupted

The pandemic has had a significant impact on our work as all studies for newly recruited patients were put on hold. We also halted new recruitment to minimize the number of patients coming in, so as to limit their exposure to any risk, as well as the risk to our staff. Only trials that involved administering a drug for essential care, such as established anti-VEGF therapy for wet AMD or diabetic macular edema, continued uninterrupted.

We also continued administering investigational drugs to those undergoing clinical trials so as to not compromise the integrity of our studies. And that meant we had to be cautious from the very beginning of the virus spreading. It was only by creating a safe environment – providing proper sanitation, wearing masks, and allowing adequate space and time between patients – that we were able to continue delivering essential care to those who needed it most.

Inevitably, there was a small hiatus in certain studies – those considered to be non-essential – such as the dry AMD trial, where there is currently no established treatment. Instead, we found alternative ways to monitor patients who experienced a gap in their so-called treatment (so-called, because it may or may not have been working). Where possible, we transitioned to a telemedicine approach, whereby patients would be reviewed over the phone and only brought in if there were any issues. Fortunately, since the pandemic only kept us in lockdown for three months, most patients only missed one or two visits.

Once restrictions were eased, all studies went back to active status. We are now almost back to normal in terms of the way we conduct clinical trials and we are even recruiting new patients into our studies. Though we are up to speed from a clinical and research standpoint, we have protections in place to guard against COVID-19. I’m happy to say that the overall impact on our annual research output was minimal. Many projects continued, and we continued writing and publishing papers, so we are not far behind.

As long as we don’t get a major second wave, I don’t feel as though we have lost significant ground. And that’s great news; we were initially concerned that an extended lockdown would affect patients’ ability to visit the site, and compromise the integrity of our data as a result. Fortunately for us, a three-month delay has allowed us to preserve trial integrity across the board.

Of all the creative solutions put in place throughout lockdown, telemedicine is perhaps the most significant.

It seems to me that it is not the research institutions who have been most affected by the pandemic, but the companies that sponsor the trials. Delays to new patient recruitment leads to delays in a trial being completed, which impacts businesses financially. That said, given that it takes 1–1.5 years to recruit patients into a study, it could be argued that three months is not such a significant amount of time... There are undoubtedly lessons to be learned from the past few months, especially when it comes to protecting patients from infection. I think that many of our current safeguards – from thoroughly sterilizing equipment to maintaining adequate space between patients – will remain in place long after the pandemic ends. And the humble handshake is probably gone for good.

Clinical research mirrors what we do in practice, so it would make sense for a lot of these safety measures to stay the same. But of all the creative solutions put in place throughout lockdown, telemedicine is perhaps the most significant.

I have no doubt that future studies will incorporate virtual approaches to following study participants. In ophthalmology, it can be hard to do everything virtually, but with more and more resources made available, I am sure both clinical care and research trials will be quick to take advantage of both available and future technology. And why not? The benefits of this new approach – both in terms of safety and cost effectiveness – benefit everyone. The types of measures being explored now will hopefully minimize and streamline study visits, and will perhaps even become a high priority in protocol designs in years to come.

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About the Author

Carl D. Regillo

Chief of the Retina Service at Wills Eye Hospital

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