Managing ongoing Clinical Trials in the current COVID-19 pandemic situation
The impact of the pandemic on European health systems and more broadly on society, makes it necessary for sponsors to adjust how they manage clinical trials and the people who participate in these trials. In view of the extraordinary pressures on health systems affecting clinical research conducted in hospitals, EFPIA is working collaboratively with the Clinical Trials Expert Group (CTEG) of the European Commission, supported by European Medicines Agency (EMA) and the Clinical Trials Facilitation and Coordination Group (CTFG) of HMA as they provide sponsors with harmonised guidance in Europe[1].
Clinical trials are necessary in developing a new medicine, they serve to test its efficacy and safety. They are crucial for the patients that participate in them as they offer the chance to receive a new treatment, that has potential to improve their quality of life, help the management of their disease, or in some cases prolong or save their lives.
The COVID-19 pandemic is an extremely stressful time for all, especially for patients and vulnerable communities. EFPIA shares the concerns of patients and regulators in case of the potential disruption of the on-going and planned trials caused by COVID-19 pandemic.
EFPIA is joining forces with regulators in Europe to monitor the impact of COVID-19 on clinical trials currently underway and to minimise the impact of interruptions to these studies. EFPIA member companies are preserving trial activities in hospitals as far as possible, guaranteeing healthcare for patients, protecting their safety and well-being and keeping the record of traceability of actions taken in the health emergency situations.
Impact on follow-up visits, access by off-site staff and on-site trial monitoring could be compromised by the control and prevention measures being implemented at hospital sites in the recent weeks. This situation concerns the whole of Europe. In this regard EFPIA, together with its members, is closely monitoring the impact of COVID-19 on ongoing clinical trials, prioritising critical activities and finding solutions on how to carry them out. During this time of uncertainty, it is extremely important to provide patients with up-to-date and accurate information on any change that might impact them.
In the EU, the clinical trials are authorised and supervised at the national level. However, it is of the utmost importance to strive as far as possible for a harmonised approach across all European countries as the issues are the same everywhere in this extraordinary pandemic situation. Nevertheless, should there be specific national legislation and/or guidance for the conduct of clinical trials, EFPIA is working closely with its national member associations to ensure that the trial sponsors are fully informed and can ensure minimal disruption to clinical research activities for the sake and well-being of the patients.[1] The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to manage the conduct of clinical trials in the midst of the health emergency caused by the coronavirus disease (COVID-19) pandemic.
