The Covid-19 pandemic has resulted in numerous clinical studies in Sweden and around the world. For Scandinavian CRO (SCRO), a full-service contract research organization (CRO) that supports MedTech and pharma companies with clinical research, there has been a considerable amount of interest in carrying out Covid-19 studies with SCRO.
Both the Swedish Medical Products Agency (MPA) and the Swedish Ethical Review Authority (EPM) have implemented an accelerated path for Covid-19 research, prioritizing clinical research that has the potential to impact patient care in the near future. Even if the clinical trial application process is faster than usual, it still takes approximately 2 months of work before a study can get started.
“We are seeing a large increase in clinical studies that require access to Covid-19 patients or patient material. There are many companies that want to start up a clinical study as quickly as possible to test their research idea,” says Ulrika Heldestad, Head of Clinical Operations at Scandinavian CRO.
She continues: ”Our first Covid-19 clinical trial has recently been approved by the Swedish MPA/EPM and we will start including patients into the study very soon.”
The hospitals that SCRO has been in contact with have shown a considerable interest in participating, although a few have had to decline due to competing studies or limited resources. “The fact that these hospitals have been selective about which studies they can work on is positive,“ says Ulrika, “since it is crucial that sites have the appropriate resources to carry out the clinical studies they take on.”
She adds: “It is important that the study is planned in tight collaboration with the clinics. It is critical for us to know what works and what doesn’t work during these unusual times, and the site personnel are experts on what works best.”
Even if getting clinical research results regarding Covid-19 is urgent, the safety of the clinical trial participants is always the highest priority.
Absolutely, that is the most important, says Ulrika. ”A clinical study should never compromise the safety of the participants nor patient care.”