CLINICAL TRIAL DISRUPTION W
We found that trials in toxicology and
neurological conditions were among the most frequently suspended, delayed, or prematurely concluded. In contrast, oncology trials – particularly for skin cancer – were most able to continue operations without major disruption. According to investigators, patients who
previously deferred their periodic check-ups, as well as sponsors that delayed trial initiations, are now coming back to clinics. This allows for clinical trials activity to start recuperating. But there are still lingering obstacles, such as staff shortages and delays in funding and regulatory reviews, especially affecting certain disease areas. When the pandemic hit in March 2020, it led to an immediate boom in COVID-19 clinical trials. But progress in other therapeutic areas stalled: sponsors suspended enrolment, initiation dates were pushed back, and many trials terminated. In the first six months of the pandemic, trial
enrolments dropped because of the risk of COVID-19 infection at clinical trial sites such as hospitals, and investigators pivoted toward COVID-19 research or were furloughed, explains Brooke Wilson, associate director, GlobalData Clinical Trials Intelligence. Some trials – such as heart transplants where the patient must be immune-suppressed – were too high risk to continue, she adds. Many hospital operating rooms became intensive-care units, causing disruption to trials with elective heart or kidney surgery. Some two years on, clinical trials progress
appears to be on track to recover, based on data and our interviews with investigators. But this high-level view masks asymmetric impacts at a therapeutic level, with many conditions being more severely affected by the pandemic and taking longer to recover. To examine the impacts of the pandemic in
detail, we used archived
ClinicalTrials.gov data from the Clinical Trials Transformation Initiative. Using monthly archived data going back to January 2018 allowed us to identify the historic status and
anticipated start date of each trial. By stitching these data snapshots into a single dataset, we were able to track when trial initiation delays occurred and when trials were reported as suspended and resumed.
Variation in restarting suspended clinical trials The analysis found that, overall, 7% of trials with US sites that were in the recruiting phase during the first quarter of 2020 were at some point reported as suspended during the next two years. Nausea and obesity trials were among the
most likely to experience suspensions in early 2020, with 11% and 10% of studies suspended, respectively. Some oncology conditions such as sarcomas and gynaecological cancer also had high suspension rates. But, non-resumption rates were higher for some conditions. For example, for psychiatric disorders, where one in 10 trials were reported as suspended, half of those had not resumed activity at the time we made our findings public in March 2022. For obesity and diabetes, the non-resumption rates were 36% and 35%, respectively. A caveat with analysing clinical registry data is
that analysis relies on sponsors providing updates in a timely manner. While our findings almost certainly underestimate the true overall impact of the pandemic on the sector, they still offer insight into which areas have been most heavily affected.
Toxicology clinical trials severely impacted Toxicology trials experienced both high initiation delays during the pandemic and high rates of recruiting trials being suspended. Between April and September 2020, 8% of recruiting toxicology trials reported suspensions, higher than the equivalent rates for oncology (5%) and infectious disease (6%). Toxicology trials were also slower to resume. In the third quarter of 2020, recently resumed trials made up 2% of all active non- toxicology trials. In comparison, only 1% of toxicology trials were newly resumed. Toxicology trials are designed to look at
safe dosing regimens and for toxicity risks, GlobalData’s Wilson explains. The GlobalData Clinical Trials database shows that, in the top drugs in the toxicology category, many of these trials are for the steroid dexamethasone, which is a chemo-induced nausea treatment, she adds. In the past two years, cancer patients, many of whom are
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