Research during the pandemic
Thomas Kohnen MD, PhD
As clinical studies and basic research that were put on hold around the world begin to resume, researchers are finding something of a silver lining in the COVID-19 cloud. Reduced clinic hours allowed many to finish analysing, writing, editing and submitting studies, papers and letters, resulting in a marked increase in literature volume. The need to use internet platforms to communicate during lockdowns has also resulted in unexpected opportunities for new collaboration.
From March through early May, submissions to the Journal of Cataract and Refractive Surgery increased by about 40%, said Editor Thomas Kohnen MD, PhD, of Goethe University, Frankfurt, Germany. “I personally was very productive, too.”
With his surgery schedule down to three or four cases daily from 10-to-15, Dr Kohnen estimates he completed 10-to-15 studies and letters to the editor over the period and had time to develop new ideas.
“It was like a little COVID sabbatical for three months.”
As the pandemic took hold in March and April, every ongoing clinical study at Goethe was shut down for eight weeks, Dr Kohnen said. Elective cataract surgeries were cancelled as well, leaving only emergencies such as corneal perforations, retinal detachments and acute glaucoma, with a few patients receiving regular doses of anti-VEGF.
With COVID-19 cases stabilising in the German state of Hessen, and protocols in place to prevent infection, Goethe University began reopening in early May, Dr Kohnen said. Patient volume has since built toward normal, and with it, clinical research has resumed, with all postponed studies restarted.
However, effects of the pandemic are being felt, Dr Kohnen added.
“Patient recruitment is slower; some may not come because they are afraid they can get the virus.” A few patients also may be lost to follow-up for this reason.
Study protocols were disrupted in some cases as well. For example, three-month follow-up was missed for some patients in a study for FDA approval of an IOL for presbyopia. “Because of the COVID, we saw them at 100 days instead of 90 days,” Dr Kohnen said. These deviations will be reported, and adjustments made. Sponsors and regulators are supportive of the effort.
Overall, the impact on research was minor, Dr Kohnen said. “It was just a hole for eight weeks,” he said.
Both basic research and clinical studies were shut down at the S Fyodorov Eye Microsurgery State Institution based in Moscow, Russia, said Boris Malyugin MD, PhD. Overall, the system has about 35 studies in progress at the Moscow clinic with three-to-five studies at each of the 10 locations around Russia.
As the clinics reopened, bench studies resumed as researchers returned to work. Clinical studies are beginning to resume as patient volume grows – though as of early July it had reached about 35% of previous capacity with full capacity unlikely to be reached until year’s end, Dr Malyugin added.
The lockdown and restrictions on travel for older persons both resulted in disruptions to several ongoing trials, causing missed follow-up appointments. Even in an ongoing anti-VEGF study that was continued, protocol deviations occurred, and some patients may have to be excluded from the study analysis because of it, Dr Malyugin said.
However, the study sponsors are well aware of the problem and are extending study timelines to accommodate the need for additional patient recruitment. Because inclusion criteria are so tight, recruitment will also be slower due to reduced patient volume, Dr Malyugin said.
“It is more or less good news for us. However, the development of some drugs and other products will be delayed.”
Dr Malyugin also found his time off from clinic productive.
“It was a good time to sit at home and work reading and writing papers and editing papers. It was a productive time away from actual research.”
It also created an opportunity to collaborate with colleagues all over the world using internet platforms, Dr Malyugin added. “We discussed ways to be more effective under the epidemic circumstances and did some nice brainstorming.”
The result was several articles on coping with the pandemic for publication, including two in the EuroTimes COVID-19 e-newsletter.
Dr Malyugin continues to communicate with colleagues via internet as he resumes regular clinical duties. He sees it as a new and productive way to advance research.
“It will change collaborative research. We are seeing a surge in communication among doctors on different internet platforms in a way we have never seen before.
Still, the pandemic is taking its toll. Dr Malyugin said it has not affected him or his family directly but noted that a lot of colleagues have been affected.
“We even had some casualties in the ophthalmic community and that is very sad to mention,” he said.