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Home » Clinical Trials » Keeping phase I clinical trials running safely during a pandemic

Katrien Lemmens, MD

Medical Director CPU, SGS

The pandemic has profoundly reshaped life as we know it. Over the past 12 months, many offices largely transitioned to remote working. However, for those conducting phase I clinical trials, this simply wasn’t possible and adaptive measures had to be enforced. 

After the first lockdown was announced in March 2020, as an organisation, we set about devising a strict COVID-19 risk mitigation plan. This allowed us to resume our phase I trials as quickly as possible – a plan still in place a year later.

Tackling infection rates

All wards, offices and other areas had to be redesigned in order to apply 1.5m social distancing measures at all times. This meant a reduction in total bed capacity and limited our on-site monitoring capabilities. Sanitising alcohol gel and face masks were introduced en masse, which quickly became a part of the staff’s daily routine.

Our PCR testing strategy was a valuable tool in tackling peaks in overall infection rates.

Upon admission, all volunteers were tested for SARS-CoV-2 with an onsite PCR and the results were available within the hour. If a volunteer ever developed COVID-19 symptoms throughout their stay, further tests were immediately conducted. Symptomatic members of staff, or those who had close contact with patients displaying symptoms, were also tested. This procedure was reinforced by a decision flowchart that was clearly displayed in each ward.

Our PCR testing strategy was a valuable tool in tackling peaks in overall infection rates. Between June 2020 and April 2021, over 2,000 volunteers were screened and only 20 positive cases occurred. The majority were detected before dosing and were replaced by reserve subjects. Only 0.72% of all those we tested were COVID-positive, compared to Belgium’s peak of 29.2% in November – with this rate still languishing above 8%.

Returning to a new normal

While these strict rules certainly posed a significant challenge, our stringent preventative measures and rigorous testing limited the pandemic’s impact on our phase I trial activity. With vaccination rates steadily increasing and all our staff now having been vaccinated, we’re cautiously optimistic about returning to a semi-normal state of affairs during the final quarter of 2021. We will be moving into our brand-new building in September, which will further increase our total bed capacity.

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