The outbreak of COVID-19 affects the pharmaceutical industry in several ways. One example is its impact on clinical trials, where several sponsors have decided to postpone or cancel planned or ongoing clinical trials. The Swedish Medical Products Agency (“MPA”) has published advice on how sponsors could handle challenges caused by the current situation. Setterwalls will keep you updated.
The MPA has published advice regarding the handling of clinical trials as a consequence of the outbreak of COVID-19. The intention of the advice is to assist the pharmaceutical industry and support affected companies regarding the conduct of clinical trials in the current situation. All information published by the MPA in relation to these questions is available here. The Commission has also published guidance relating to the conduct of clinical trials in the current situation, available here.
Urgent Safety Matters
Urgent situations that are related to COVID-19 can be handled as urgent safety matters. Urgent safety matters are normally carried out if it is necessary to protect trial subjects from immediate danger. Such measures do not require approval from the MPA to be carried out. However, the MPA must be informed without delay about which measures that have been taken. For patient safety reasons, a thorough risk assessment shall be made of the measures to be carried out in each individual case.
Investigational medicinal products
The MPA understands that investigational medicinal products that are usually delivered to the trial site first and then to the patient, may have to be delivered directly to the home of the trial subject. In such cases, it is important to consider certain aspects, such as that the sponsor is not allowed to know the identity of the trial subject. Therefore, deliveries should be performed by the hospital or the pharmacy involved in the trial. Investigational medicinal products may not be delivered to mailboxes or left by the door. The handling and delivery of investigational medicinal products must be documented.
Deviations from the clinical trial protocol may be required, e.g. because a trial subject cannot visit the trial site. Such deviations must be documented by the sponsor. Even though deviation due to COVID-19 do not necessarily qualify as serious deviations, the MPA encourages sponsors to evaluate whether the deviations are to be classified as serious deviations in each case. A serious deviation is a deviation that can affect the integrity or safety of the trial subject or the scientific value of the trial. Such deviations must be reported to the MPA in accordance with regulation LVFS 2011:19, Chapter 8 Section 11.
Amendments of the protocol
If a sponsor considers that it is necessary to amend the clinical trial protocol due to the COVID-19 situation, the sponsor must submit an application for substantial amendments in accordance with the MPA’s regulation LVFS 2011:19. Such amendments should be motivated, and the consequences for the trial subject as well as for the scientific value of the clinical trial should be described. It should be clearly stated that the application for a substantial amendment is made due to the COVID-19 situation. If the application states “COVID-19” in the subject field, the MPA can handle the application with urgency.
It is our understanding that the MPA seeks to encourage sponsors to find pragmatic solutions within the regulatory framework to cope with the challenges that COVID-19 causes for clinical trials.
It should be noted that several funding opportunities for research connected to the COVID-19 have been announced by e.g. Vinnova. Funding is offered for research related to both treatment and diagnostics. More information is available here.
Setterwalls are up-to-date on the development of COVID-19 and its impact on the Life Science industry.
Please do not hesitate to contact our specialists if you have any questions or want to know more.