The pandemic releases its grip on clinical trials

The vast majority of industry-sponsored studies suspended because of Covid-19 resumed quickly, a new analysis finds.

Other data

A year ago the pandemic started to disrupt clinical research, resulting in the suspension of more than 2,000 trials over the course of 2020. It is heartening to discover that around half of these studies have resumed, a new analysis from Evaluate Vantage finds, an impressive statistic considering that Covid-19 is still causing huge global upheaval.

In fact, the full data reveal a remarkably short-lived impact to biopharmaceutical research. The vast majority of studies that remain on pause are observational or those involving non-drug-based interventions. Only 54 industry-sponsored trials remain suspended, a reassuringly small number for those biopharma watchers concerned about the short and long-term impact of the pandemic.

This is not to suggest that research escaped unscathed, and it seems likely that huge swathes of academic work, particularly projects taking place in hospitals, were severely curtailed, and remain disrupted. But commercial biopharma companies have, in the main, managed to restart stalled projects; an acceleration in the use of digital tools to run trials has played an important role here.

This analysis uses clinicaltrials.gov data, focusing on changes made to trial entries that concern the recruitment status of a study. Those that were changed to suspended, terminated or withdrawn between January 2019 and December 2020 were identified.

Covid-19 would not have been the reason for all of the status changes last year. But the data for 2019 show that the number of trials being suspended, terminated or withdrawn each month, in a more typical year, remains fairly static. Clinicaltrials.gov includes a field where sponsors can cite a reason for any change, but those given are frequently vague.

In 2019 an average of 46 trials were suspended each month. In 2020 the impact of the pandemic is obvious: April was the worst afflicted, with 801 suspensions registered. December 2020 was still tracking above 2019’s monthly average with 75 suspensions, suggesting that the impact of Covid-19 was still being felt.

Interestingly, the number of trials terminated or withdrawn last year rose only slightly on 2019. But this is a metric to keep an eye on, as it seems probable that a big proportion of trials still suspended might never restart.

A hint that this might be the case can be seen in final months of 2020, when, until December, withdrawals and terminations ticked up.

It is obviously worrying that around half of the 2,000 trials suspended last year remain on pause. But the other half have resumed, and there is another positive finding in the data: interruptions were mostly brief. The chart above displays time in suspension for the 1,000 or so trials that are up and running again, with most on pause for only a couple of months.

It should be remembered that this analysis covers all trials in clinicaltrials.gov, and that academic institutions or hospitals will be the primary sponsor of most studies registered. It is hard to estimate what proportion of trials are sponsored solely by a commercial company – and therefore of more interest to investors and industry followers – but the figure probably lies somewhere between a quarter and a third of those in the registry.

A deeper dig into those that remain suspended again suggests that non-commercial sponsors are bearing the brunt of the ongoing disruptions to clinical research. This analysis uncovered only 54 industry-sponsored trials that have yet to restart. Again, Covid-19’s role cannot be completely confirmed in all cases; many entries simply give “company decision” as a reason for the suspension.

The pandemic will leave its mark on the business of drug development for many years to come. But biopharma bounced back quickly, and the sector’s clinical work took less of a hit than many feared back in spring 2020.

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