Our work before pandemic seemed to be easier, but there’s no turning back, because we have developed many good practices that we intend to keep

There is no turning back, the good practices are here to stay – said Małgorzata Geriatowicz-Osmańska Pratia’s Regional Clinical Research Director in Kraków, and took an in-depth look on how the way of working of research sites have changed due to the pandemic. Obviously, the pandemic has accelerated the development of new procedures and new technologies, which will stay with clinical trials from now on.

As a Director of Research Sites, what differences do you see in the everyday operations of your Sites, Monitoring Visits, Patient Recruitment, and Enrollment?

Right after the pandemic occurred, the recruitment in many trials was suspended or even canceled. Since we are conducting many trials with monoclonal antibodies affecting the immune system, our investigators were concerned about the safety of their ongoing Patients. So, we have introduced epidemiological safety measures for both Patients and Site staff including monitors, that have remained with us to this day personal protective equipment, social distance with separated areas for patients, coordinators, monitors, disinfection, epidemic surveys, testing, remote visits in case investigators were employees in hospitals, home medication delivery for high-risk patients. We made every effort to ensure that our patients were safe and did not have hindered access to medical care.

The monitoring visits were ceased as well, so after they have been overturned, we were dealing, and we still are, with the huge backlogs, even if we quickly made remote monitoring visits possible.

How would you describe conducting Clinical Trials before the Covid-19 pandemic?

We preferred individual and direct communication, so we had no motivation to create more repeatable and uniform processes and systems

Our work before the pandemic seemed to be easier, but there’s no turning back. We have developed many good practices that we intend to keep. But the possibility to return to more direct contact with our patients and monitors gives us great joy.

How does all of that differ for a single Site and for the network of Sites?

Many independent sites have struggled due to a lack of cash flow or staff availability. Being part of an international network gives us access to financial security, remote management systems as well as the possibility of staff exchange.

However, the biggest advantage of being part of a global company is having access to the people and resources to implement bold ideas. The most important project in which I had the opportunity and pleasure to participate, was the development and introduction of a platform for conducting clinical trials, combining Clinical Trial Management System and the possibility of creating Electronic Health Records and allowing remote access. The platform was planned anyway, but the pandemic significantly accelerated its creation. 

What kind of new ways of conducting Clinical Trials have you observed or you would wish to have at that point in time to improve the feasibility of those trials due to the restrictions that influenced the trials? (technology, decentralized studies / virtual studies).

We dreamed of a magic multi-location tool for our staff in order to monitor all our patients without contact. Being able to work in a home office for our rotating coordinators has become equally important. Breaking with our habits was quite difficult, but thanks to communication platforms and secure servers, our work gradually became acceptable. 

What has changed in terms of contact with the Patients participating in the Studies? How the use of technology influences them?

Our investigators as well as our patients had to agree to use remote medical appointments and they accepted it to some extent. It is now much easier to plan partially or fully virtual studies

The use of wearables and even smartphones for clinical trial purposes instead of e-diaries is much wider. Home visits, on the other hand, were not very popular with our patients. 

What is the future of Clinical Trials post-Covid? What will stay with us? (In terms of Patients? In terms of processes?)

More hybrid or fully virtual trials, remote access to data, closer, constant improvement of clinical trials processes, and more frequent on-line Site-CRO-Sponsor communication are inevitable. But we must remember that we work with patients, often suffering or anxious people whose safety and well-being we must first take care of. 

Do you think the industry is ready for digitalization or to what extent is it ready?

There is no other way. But we had to do it gradually, making sure we were following both global and local (sometimes very conservative) regulations and not losing the highest quality of our data and processes.