The pandemic has changed and, in many ways, distorted our lives. Every system has collapsed and, as it can be easily assumed, particularly the healthcare system is suffering from ineffectiveness, staff shortages and financial problems.
Donato Bonifazi, Chief Executive Officer of CVBF and President of AICRO, the Italian CRO Association, has given his mind about how the world of clinical trials has changed due to COVID-19 emergency.
We asked him to provide us some explanations and examples of how clinical trials, research and patients’ lives had to change course: “This pandemic has been unexpected and very destructive. In order to face and save patients affected from COVID-19, many hospitals have been compelled to stop studies about specific medical fields, burding also on therapeutical areas such as rare diseases and paediatrics, and this has stopped also the enrolment of new patients in clinical trials. Actually, we don’t know the ultimate effect of this pandemic, but if it goes on, we will lose the possibility to find new treatments and make patients’ life expectancies better.
The European Agency Medicine (EMA) has been really active in keeping in touch with developers who were studying treatments and vaccines for COVID-19, as they continue doing in these days; the Agency has provided a guideline with a set of criteria that developers should follow to submit their researches in order to render the situation clearer and facilitate clinical trial conduct.”
New frameworks and technologies are needed to accelerate the clinical research by avoiding unnecessary accesses of patients to centers. It’s time to bring innovation, decentralize trials, monitor remotely.