News - April 8, 2020
COVID-19: Need for undisrupted access to treatment in hospitals
The COVID-19 pandemic creates an extraordinary situation for all stakeholders. EUCOPE members are particularly concerned with the impact the COVID-19 crisis created on clinical development.
Delay of patients’ access to innovative treatment
The delay caused by the pandemic in drug development is in particular concerning in the area of investigations on unmet medical need and life-threatening diseases.
If nothing is done, we could see a delay in patients’ access to treatment and therapies in hospitals, which could have a detrimental impact. This aspect will be emerging for companies whose specialized therapies are given to patients in hospitals. With hospitals at full capacity and focusing entirely on battling the Coronavirus, we need undisrupted access to treatment and therapies in hospitals.
National divergences in clinical trials
EUCOPE notes that there is a level of divergence at EU level concerning the clinical trial guidance, with different level of pragmatism on how clinical trial sponsors can manage the uncertainty and the conduct that some trials are in. We also notice discrepancies in requirements for deviation management, urgent safety measures, and other contingency planning that requires regulatory actions;
EUCOPE asks EU authorities and national agencies to coordinate as much as possible their requirements and to ensure a harmonized, pragmatic approach across EU Member States. This will facilitate how companies, particularly small & medium enterprises, manage multi-country clinical trials and ensure patient safety is assured