May 20 is International Clinical Trials Day. Clinical Trials are essential for improving the prevention, diagnosis, and treatment of diseases. Pharmaceutical companies have been facing a unique situation related to the spread of Covid-19. They have had to continue these missions under optimal conditions for the safety of patients participating in clinical trials.
Lydie Poitout, Head of Clinical Trial Management Department within Clinical Operations at Servier, explains how the Servier Group has adapted to the circumstances.
What is the main challenge you have faced at Servier during this unprecedented health crisis?
Lydie Poitout: The main challenge we faced was when in March in a very short timeframe all clinical studies in almost all European countries were impacted by the epidemic and containment measures. First, we made sure to protect our collaborators who, luckily, were mostly already used to working remotely very efficiently.
Our main priority was of course to continue ensuring the safety of all patients participating in all ongoing clinical trials and securing the treatment and care follow-up without any interruption. The containment measures at times prevent patients from attending their hospital visits. Also, some investigational sites have had infected staff or have had to shut down some of their departments. So, for almost every study, every country, every hospital, and every patient we have had a different situation to handle, in an evolving context from one day to the next.
What solutions did you put in place?
L.P.: We reacted very quickly and worked collaboratively with all other departments involved in studies including regulatory, safety, quality, medical and data management teams. We made sure that we addressed the challenges across the studies in a consistent way, sharing experience and solutions to ensure patient safety but also to secure the study data as much as possible. We implemented some urgent safety measures with a procedure which can be put in place with immediate effect without any prior approval from competent authorities to protect patient safety.
As an example of measures taken, we organized the shipment of the treatments directly from the hospitals to the patients’ homes with the support of our local teams and we set up testing of biological parameters in local labs close to patients’ homes. Also, some patients’ study visits have been done at patients’ home via video link.
What are your thoughts about the post-Covid-19 era?
L.P.: Even though the current situation has several critical aspects, I am confident and optimistic that we can learn a lot from the crisis and re-invent the ways we are conducting clinical trials especially in terms of study design to favor for instance remote visits for patients. Also, we need to develop further the use of digital tools that are definitely essential. This is a fantastic opportunity to accelerate the changes for the benefit of clinical trials from patient and investigators perspective. We definitely need to work towards that objective.
Transparency in clinical trials