With many countries enforcing strict lockdown measures because of the Covid-19 pandemic, many companies have announced that they are experiencing disruptions to their clinical trials for non-Covid-19 indications. Since early March, more than 500 companies have publicly announced disruptions to their planned and ongoing clinical trials in press releases, US Securities and Exchange Commission (SEC) filings, and on social media. Many companies have delayed the initiation of planned trials or withdrawn the trials completely, and others have suspended enrolment in their ongoing trials or terminated the trials altogether. The majority of trial disruptions could be attributed to patient safety measures, strict lockdown requirements, social distancing procedures, and the high demand on medical professionals to treat Covid-19 patients. As lockdown measures in several countries are beginning to ease, a number of trials are beginning to slowly resume normal functioning.
The COVID-19 Dashboard on GlobalData’s Pharma Intelligence Center dynamically tracks both these disrupted trials and trials that have resumed activity. Over 130 trials are currently resuming, and more trials are being added to this category daily. According to GlobalData’s Clinical Trials Database, 77.0% of these trials are currently ongoing and recruiting participants; 17.0% are ongoing, not recruiting; and 3.7% of trials are completed. The US had the highest number of resumed trials by site locations, at 69.1%, followed by France at 12.0%, the UK at 6.8%, Spain at 6.4%, and Germany at 5.5%, as shown in Figure 1.
The main concern with restarting clinical trials is that Covid-19 regulations still exist in many countries, including lockdown measures and social distancing restrictions. In order to combat these obstacles, many sponsors must implement stricter and alternative measures to previous trial guidelines to ensure patient safety. Sponsors must ensure that inperson trials that are beginning to resume have a new set of measures, including frequent Covid-19 testing, increased cleaning of trial sites, making sure there is an availability of personal protective equipment (PPE), and ideally providing participants with suitable transportation methods to and from the trial site. This may have a direct implication on trial cost, as resuming a trial may be more costly to the sponsor due to increased precautionary measures. Companies are reviewing alternative approaches by using remote measures and virtual clinical trials, which aim to bring the study directly to the patient via online data collection and video call progress checks. In the US, the National Institute for Health Research (NIHR) has recently announced that it is setting up an outline for the reboot of non-Covid-19-related trials that were halted due to the pandemic. Efforts to resume these studies will be parallel to ongoing work on urgent public health Covid-19 studies, which will be still treated as high priority.