Since early March, more than 500 companies have publicly announced disruptions to their planned and ongoing clinical trials due to the Covid-19 pandemic. Many companies have delayed the initiation of planned trials or withdrawn them completely, and others have suspended enrollment in their ongoing trials or terminated the trials altogether. The majority of trial disruptions can be attributed to patient safety measures, strict lockdown requirements, social distancing procedures, and the high demand for medical professionals to treat Covid-19 patients.
As the initial peak of the virus started declining, many trials were set to resume activity. However, the number of cases are starting to increase again globally. GlobalData has reported on the number of resumed trials four times since the pandemic began. The first report was published on 28 May, when GlobalData reported that over 130 trials had resumed activity. The second was published on 29 June, when the number of resumed trials increased to 350. The third was published on 28 July, when more than 500 trials had resumed. The last report was published on 17 August and indicated that over 600 trials were set to resume activity. On all occasions, the US had the highest number of resumed trials.
The Covid-19 Dashboard on GlobalData’s Pharma Intelligence Center dynamically tracks both disrupted and resumed clinical trials. As of 21 September, the number of resumed trials has increased from over 600 to 741. Out of these trials, 82.2% are currently recruiting participants, 7.9% have completed recruitment but are still ongoing, and 0.5% of trials have yet to start recruiting subjects. The figure below shows that there is an overall steady increase in trials resuming activity. The general trend shows a gradual increase in the overall percentage of trials for each trial status, the biggest of which has been seen in ongoing, recruiting trials and ongoing, not recruiting trials. However, between 17 August and 21 September, ongoing recruiting trials decreased from 84.7% to 82.2% and completed trials increased from 4.5% to 6.4%.
The US has the highest number of resumed trials at 70.6%, followed by France at 7.6%, the UK and Spain at 7.3%, and Japan at 7.2%. As lockdown restrictions eased, GlobalData forecast that trial activity would resume further. However, as more nations are re-enforcing lockdown due to a globally rising number of Covid-19 cases, trial activity is expected to resume at a much slower rate than originally anticipated. In the US, the highest number of cases are found in California, Texas, Florida, New York, and Georgia. In the UK, cases have increased significantly in England, Scotland, and Wales. Companies are reviewing alternative approaches by using remote measures and virtual clinical trials that aim to bring studies directly to the patient via online data collection and video call progress checks. With so many companies shifting to alternative ways to conduct trials, it is possible that the use of virtual trials may still be prominent even after the Covid-19 pandemic ends.
Figure 1: Resumed Clinical Trials by Status.