Covid-19’s clinical damage starts to emerge

170 commercial trials were suspended in March while new patient starts slumped 65% as the pandemic swept the globe. April could look even worse.

Other data

Biopharma companies have been laying out the pandemic’s repercussions on their clinical work for weeks, but hard data on the impact are only just emerging. For instance, Evaluate Vantage has uncovered 170 commercially-focused studies that have been suspended since March with Covid-19 cited as the reason. 

Numbers from Medidata, extracted from 4,600 active studies, paint an even starker picture: new patient starts in March dropped 65% year-on-year, worsening to a 75% slump in the first two weeks of April.

First to the trial registry data, which was pulled via EvaluatePharma to provide a snapshot of commercially-focused studies. The analysis excludes academic or government-backed work, which could well be experiencing even more upheaval.

The studies below were uncovered by extracting all clinical trial entries that have been updated since March, and examining those marked suspended, terminated or withdrawn. For the most part, sponsors provide a reason for changing the recruitment status of a trial, and 173 in total blame Covid-19.

The vast majority, 170, have been suspended rather than scrapped, so the hope has to be that much of this clinical work will resume. However because updating clinicaltrials.gov is voluntary it seems probable that this analysis understates the disruption. 

A much more sensitive examination of the impact on clinical studies can be found in numbers from Medidata, a technology company that sells a platform on which sponsors run their trials. Their figures are extracted from 4,600 active studies, across 182,227 global study sites.

New patients entering clinical trials for actively recruiting studies
  YoY March 2020 vs March 2019 YoY Apr 17 2020 vs Apr 17 2019
All countries -65% -75%
China -68% -39%
Japan -44% -57%
France -68% -80%
Germany -33% -76%
Italy -53% -37%
Spain -68% -81%
United Kingdom -80% -98%
United States -66% -80%
Note: first two weeks in April, for both years. Source: Medidata Solutions.

It is logical that countries that have been hit hardest by the pandemic should see the biggest impact. The dramatic drops in big centres of research like the US and UK is particularly alarming. Some encouragement can be seen in the statistics from China, which is already recovering, suggesting that other regions should follow.

A further analysis below, of visits per study subject in ongoing trials, also shows the impact of stay-at-home policies and the refocusing of healthcare systems.

Of course the specific damage being done here is loss of data, and erosion of the integrity of these trials. Losing patients to follow-up can be a problem outside of a pandemic, and whether these studies can survive such severe disruption has yet to be determined.    

But these numbers show that the damage being inflicted is very severe, and in many regions life is a long way from returning to normal. 

Medidata Solutions

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