CLINICAL TRIAL DISRUPTION
immune compromised, may have been less inclined to come into a hospital just to try anti-nausea medication, she notes. On a positive note, clinical trials in certain
indications persisted throughout the pandemic. Skin-level oncology trials were among the least likely to see recruitment suspended. Bacterial infections, which saw large trial initiation delays, also had relatively few suspended trials – in fact, just 4% of recruiting trials in early 2020 would be reported as suspended at any stage over the next two years. Melanoma investigator Dr Ahmad Tarhini says while there was some slowdown in the early months of the pandemic, skin-level oncology clinical trial sites adapted quickly. The motivation to keep trials going is the urgency for treatment right after diagnosis, explained Tarhini, who works as cutaneous clinical and translational research director at the Moffitt Cancer Center in Florida.
More than 300 clinical trials stopped As for clinical trials that were stopped altogether during 2020 and 2021, 339 trials had premature conclusions, with disruption due to the pandemic listed as the culprit. This accounted for 2.2% of all trials that concluded during this period. For cerebrovascular and neurocognitive disorder trials, the rate was far higher. Specifically, their respective rates of trials concluding prematurely due to COVID-19 were 5.2% and 4.5%. Premature conclusion rates were also above average for other neurological conditions including brain disease, neurodegenerative disease, and neurologic manifestations. Dr David Liebeskind, professor of neurology at
the University of California and director of the UCLA Stroke Center, notes that the prominence of stroke cases didn’t diminish in the past two years; it’s just that the referral pathway has changed. Cerebrovascular disorder investigator Aristeidis Katsanos adds that it was harder to approach potential patients to participate in clinical trials in the past two years as they did not want to do additional medical tests necessary for such investigations. Patients with mild stroke and transient ischaemic attack deferred hospital visits, and thus made it harder to find these patients for trials, adds Katsanos, neurology assistant professor, McMaster University, Ontario, Canada. Stroke patients with a SARS-CoV-2 infection were not unusual, notes Liebeskind. And patients
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who have both issues are not ideal for typical stroke clinical trials as they have different treatment schedules, he explains. Having both conditions increases a patient’s risk of mortality, Katsanos points out. That said, Katsanos notes clinical trial activity at
his centre is building momentum. In clinical trials he is designing, remote visits are being actively integrated into the design, he adds. With UCLA having staff working from home, trials have adapted remote enrolment, remote consent, and remote follow-up visits, Liebeskind says.
Initiation delays detailed While it may be known that the pandemic triggered broad clinical trial initiation delays, the magnitude of such delays is not yet clear. And so, to measure initiation delays, we looked at the percentage of trials that ultimately began more than six months after their anticipated start date. We defined these trials as “significantly delayed”. For this analysis, we excluded trials where the initiation date was only added to
ClinicalTrials.gov after the trial had already begun, as it was not possible to identify the original planned start for these trials. Prior to the pandemic, toxicology trials were
already the most likely to experience initiation delays, with almost one in three trials being significantly delayed between January 2018 and October 2019. Once COVID-19 hit, this figure rose sharply to 58%. For many therapy areas, start delays returned to normal levels towards the end of 2020. But this was not the case with toxicology as delays remained high.
Initiation delays in traditionally punctual trials We also saw that initiation delays increased significantly in many disease areas where trials traditionally began closer to their planned start dates. One example is in coronary disease. In 2019, fewer than 20% of these trials experienced significant initiation delays, but during the peak of the pandemic, 50% of coronary disease trials were delayed more than six months. Cardiovascular disease and diabetes investigator
Dr Matthew Budoff, professor of medicine at UCLA, says for any stable disease that doesn’t mandate regular follow up, patients were particularly likely to defer their visits during lockdowns. He says he hasn’t seen some of his patients for two years, adding: “If I can’t see them, I
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