Clinical trial suspensions rocket in the wake of Covid-19

An across-the-board clinical trial registry analysis spells out the effect of measures to slow the spread of the new coronavirus.

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Big pharma companies including Merck & Co, Eli Lilly and Roche have warned of disruption to clinical trials owing to the Covid-19 pandemic, but these have tended to focus on new patient starts. A new analysis carried out by Evaluate Vantage paints a somewhat starker picture.

In particular, the past two months have seen a 15-fold increase in trial suspensions, irrespective of the reason given, this latest analysis finds. It looks at every industry-sponsored phase I to III study listed on clinicaltrials.gov, and notes every change made to each entry between January 2019 and the end of last month.

This is useful not only because it provides an independent analysis of the current state of play, irrespective of the reasons companies give in public pronouncements, but it also allows this to be compared against a baseline number of clinical study setbacks that would be expected to occur outside the Covid-19 lockdown.

Thus in an average month around 50 trials tend to be suspended for any reason. But, with the world moving towards lockdown March saw a jump to 280 studies being marked suspended, and this snowballed, with 731 further trials being suspended in April.

These figures differ from Vantage’s previous analysis, which was carried out last month and looked at trials that had been marked suspended, but only with Covid-19 being given as the reason. This identified 173 such studies (Covid-19’s clinical damage starts to emerge, April 23, 2020).

Interestingly, it is the status change of trials where the most acute effect of Covid-19 is being felt, and for now this only concerns study suspensions. There is no obvious impact on trial terminations, for instance.

Neither do studies’ primary completion dates appear to have been affected. Just over 3,000 and 2,000 trials had their completion dates delayed in March and April respectively, figures that are exactly in line with averages across the previous 14 months.

However, it should be remembered that in many cases primary completion dates on clinicaltrials.gov are mere estimates, and are frequently at odds with reality.

It is possible that an effect on expected completion dates will only become apparent in this type of analysis in several months’ time, once industry sponsors have come to terms fully with the precise impact of the measures taken to combat the spread of Covid-19.

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