I would like to begin by saying I hope you and your family are staying safe and healthy during this uncertain time. I know the COVID-19 pandemic is having an impact, both professionally and personally, on everyone.
In the last three months, we have seen the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spread globally; at the time of writing, there have been more than 1.6 million cases of COVID-19 reported – and approaching 100,000 deaths. Scientists are accelerating the vaccine development process and vaccine candidates are already moving into clinical trials, faster than ever before.
There are also thousands of unrelated clinical trials being affected by the pandemic. As of March 2020, ClinicalTrials.gov listed 262,366 ongoing randomized clinical trials, the integrity of which may be under threat.
Feeling the impact of COVID-19
This impact is certainly affecting the majority of Siron Clinical clients. At clinical trial sites, study team members have been reallocated, either working from home or supporting medical teams and lower the hospital burden in the treatment of COVID-19 patients. Subject study visits held at study sites have been cancelled or held remotely, and screening and the inclusion of new study subjects are on hold.
We are feeling the effects of the pandemic at Siron Clinical too. Our direct experience started in Italy in early March – due to the travel restrictions put in place, our CRAs could no longer travel for monitoring visits. This spread gradually across Europe, and by the end of March, on-site monitoring was impossible in most countries. Quite rightly, hospitals have shifted all their activities to treating COVID-19 patients, and they no longer allow CRAs to enter the hospitals.
Within Siron Clinical, we already had the systems and processes in place for home-based work, so these changes did not dramatically change our routine – CRAs are continuing to work from home. To maintain regular internal communication, we implemented weekly online meetings, and project-related meetings continued as normal, since they were already mostly virtual.
Supporting clients through the pandemic
Our client support continues– we remain the link between the sites and our clients. We still have good communication with the sites, and we have evaluated remote monitoring possibilities on a site-by-site basis. We are using the remote monitoring tools available, and we continue our support to sites with IMP shipments to patients, while the sites conduct remote subject visits.
While setting up these procedures, we continuesly monitor and ensure patient safety and study medication compliance. We are focused to continue the studies for the patients who were included before the pandemic, by working closely with the sites and clients, particularly for the clinical studies in rare disease indications and studies involving minors.
In such a fast-changing global event, we keep clients and sites informed about the situation in the various countries, through our local representatives. We share information directly and through our communication channels, including the latest guidance from the EC on how to “mitigate the negative effects of the COVID-19 pandemic on the conduct of clinical trials.”
What you can do today, to prepare for tomorrow
As we continue to navigate this unfamiliar situation together, we can all take steps to ensure we are prepared for what may come next. If your clinical trial is on pause now, my main advice would be to use this time to get ready to restart in close collaboration with your partners. Maintain good contact, communicate often and clearly, and share objectives and plans.
If you have yet to start your trial, this is a good time to ensure you have everything in place for when you can start. Check your systems and processes, work with your collaborators and solve any potential problems ahead of time.
Importantly, whatever the impact COVID-19 is having on your clinical study, stay up-to-date with what is happening out there. Follow official guidance, both national and regional. Understand what your partners are going through too – they may be affected differently. And work with us at Siron Clinical – we can guide you and your clinical trial through these challenging times, and we will be ready to go when the situation shifts.
You are welcome to contact the Siron Clinical team with any questions you may have about the COVID-19 pandemic, how it is affecting your clinical trial and how Siron Clinical can help you. For the latest information, you can also follow us on Twitter and LinkedIn, and sign up for our monthly newsletter.