US clinical trial sites are most affected due to the Covid-19 pandemic

GlobalData Healthcare 7th May 2020 (Last Updated May 7th, 2020 13:08)

US clinical trial sites are most affected due to the Covid-19 pandemic

With the recent development of the current Covid-19 pandemic, there has been an increased urgency for both industry and non-industry sponsors to focus on finding a suitable therapeutic or vaccine for this highly contagious viral disease. In an effort to find a suitable treatment and prevention options for Covid-19 infection, more Covid-19 clinical trials are being planned and initiated, while a large number of clinical trials for non-Covid-19 indications are suffering delays.

With many regulatory agencies such as the FDA and EMA offering accelerated approval for Covid-19 therapeutics and vaccines, it could be in part that sponsors have shifted focus and research onto the current pandemic. But the majority of trial disruption could be attributed to patient safety, strict lockdown, social distancing, and the high demand for medical professionals to treat Covid-19 patients. High profile pharmaceutical companies have announced disruptions to planned and ongoing trials, postponing trial start dates and halting subject enrolment.

The Covid-19 Dashboard on the Pharma Intelligence Center dynamically tracks these disrupted trials from the Clinical Trials Database, along with the list of companies that are the sponsor, collaborator, or contract research organisation (CRO).

With over 1,000 trials being disrupted and more trials being added to this category daily, there is a direct impact on trial site activation and patient enrollment. Many of these sites are either being used for other purposes or are temporarily closed. With many countries enforcing strict lockdown measures, sponsors are unable to activate these sites, making it harder for existing trials to continue. According to GlobalData’s Clinical Trials Database, 56.1 % of disrupted trials are currently suspended while 20.7% are ongoing, but not recruiting any additional participants. When looking at site locations, the US had the highest number of disrupted trial sites at 66.1% followed by the UK at 12.8%, France at 9.3%, Spain at 6.5%, and Germany at 5.2%, as shown in Figure 1. According to the guidance of FDA and EMA procedures, many of these disrupted trial sites are now being repurposed for Covid-19 trials. Activation of new trial sites is usually not recommended for non-Covid-19-related trials unless no other solution exists for the ongoing trials. According to the EMA, “If there is an urgent need to open a new trial site for critical trial visits, for example outside the hospital, this may be implemented as an urgent safety measure (USM) first, followed later by a substantial amendment (SA) application for the approval and initiation of this additional site.” With the possibility of reallocating trial sites, there is also the need to move subject data such as medical records. In such cases, it is highly recommended from the EMA that this is done virtually and that any eCRFs can be adjusted accordingly to allow the receiving site to enter new data.

Due to site closures and lockdown measures, many companies involved in trial site management and coordination are feeling an economic hit. The top three countries with affected companies are the US, UK, and France. Contract research organisations are experiencing a hit too, with many organisations having to disrupt trials. According to GlobalData’s Clinical Trials Database, the top three CROs that are affected are IQVIA, Covance, and Sarah Cannon Research Institute. Among CROs, a statement from ICON highlights that 65% of their global sites are impacted in some way, which poses a period of financial uncertainty. Many 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. It is important to note that with many countries easing lockdown, some trial sites may begin to reopen slowly to focus on other studies. With many companies shifting to alternative ways to conduct trials, it is possible that even after the Covid-19 pandemic the use of virtual trials will remain prominent.