The COVID-19 crisis places a huge burden on the healthcare systems of countries around the world. In many countries, non-essential healthcareis being put on hold to allocate more resources to treating COVID-19 patients. This impacts ongoing and planned clinical research. Not only do shifting priorities within the healthcare systems impact studies: travel and contact restrictions are likely to disrupt patient visits and on-site monitoring visits.
The potential effects on studies include slow-down of enrollment and increases in missed visits, patient drop-outs, protocol deviations and adverse events. Delays in the approval by health authorities of non-COVID-19-related research may be expected. Some studies will have to be postponed or suspended.
Since the outbreak of the COVID-19 crisis started, health authorities have recognized this impact on clinical research. The authorities have responded by publishing guidance documents to help pharmaceutical companies and medical device manufacturers understand the actions they should take when their trials are affected.
The downstream impact on the industry and on patients is – like so many aspects in this crisis – impossible to yet oversee. It is probable however that important new technologies and treatment options will not reach the market as soon as we would like.
Below we provide an overview of some of the most important guidance currently available in different regions. These guidance documents are sometimes amended so be sure to verify that you are using the latest version by checking the news overview pages of each authority. A brief overview is given of the guidance from the European Medicines Agency (EMA) and US Food and Drug Administration (FD).
The clinical team at Qserve wishes everyone strength and patience in these times and above all good health.
European Medicines Agency (EMA), European Commission and Heads of Medicines Agencies (HMA)
Summary: When considering changes to trials, a risk-based approach must be taken. Subject safety always prevails. For new trials or new trial subjects sponsors must critically assess feasibility and address additional risks to participants. A risk-based approach is recommended to apply changes to ongoing trials. Remote visits, postponing or cancellation of visits, temporary halt of recruitment, sites or trial must be considered. In exceptional situations it may be needed to move participants out of risk areas. Critical patient assessments may need to be performed at different location/lab. Distribution of trial supplies/IVDs/Devices/medication may be adjusted. Monitoring and audit methods and frequency may be changed. GCP principles and rules still apply to studies and this includes safety reporting and documentation practices. When communicating with authorities, priority should be given to trials regarding COVID-19 and to substantial amendments to existing trials as a result of COVID-19. The guidance further gives direction regarding COVID-19 trials and, for example, alternative methods of informed consent in these trials. Note that sponsors and investigators need to take into account that there might be specific national legislation and guidance in place, which they should consult and which may take priority over this guidance.
US Food and Drug Administration (FDA)
Summary: Ensuring the safety of trial participants is paramount. Sponsors should consider each circumstance, focusing on the potential impact on the safety of trial participants, and modify study conduct accordingly. Sponsors, in consultation with clinical investigators and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs), may determine that participants may continue per protocol or discontinue the administration or use of the investigational product or even participation in the trial. Recruitment or trials may be terminated. Alternative methods for safety assessments, monitoring, processes, may be considered. Addition of COVID-19 screening generally does not need reporting as protocol amendment. Trial participants must be kept informed of changes that could impact them. Any amendments and deviations must be approved by IRB/IEC unless in emergency situations. Alternative processes should be consistent with the protocol to the extent possible, and sponsors and clinical investigators should document the reason for any contingency measures implemented. For missing data, relationship with COVID-19 must be documented. Device/drug accountability must be maintained but alternative methods of distribution may be considered. COVID-19 contingency measures, impact on each affected participant and impact on study data must be documented and discussed in the clinical study report or separate document.
Austrian Federal Office for Safety and Health Care (BASG)
Department of Health
Federal agency for medicines and health products (FAMHP)
Danish Medicines Agency
French National Agency for Medicines and Health Products Safety (ANSM)
Federal Institute for Drugs and Medical Devices (BfArM)
Health Products Regulatory Authority (HPRA)
Italian Medicines Agency (AIFA)
Central Committee on Research Involving Human Subjects (CCMO)
Spanish Agency of Medicines and Medical Devices (AEMPS)
Health Research Authority (HRA)