New book published
In spring the Association of Medical Ethics Committees published a new volume of its publication series:
The Development of Medical Devices — Ethical, Legal and Methodological Impacts of the EU Medical Device Regulation
Dirk Lanzerath, Sebastian Graf von Kielmansegg, Joerg Hasford (eds.)
Covid-19 and its effects — Information for sponsors and investigators
Last update: 28.4.2020
+++ On Tuesday 28 April 2020, the 3rd version of the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic was published in Eudralex. We kindly ask for your attention and point out that regular updates of this document are to be expected. +++
+++ The work group CTR/AMG of the Associaton of Medical Ethics Committees publishes notes on how to deal with clinical trials in times of the COVID 19 pandemic. The notes supplement the European Guidance (2nd version) with reference to the specific German legal framework and highlight the practical consequences in matters of ethics committees (available only in German) +++
+++ On Friday 27 March 2020, Eudralex published the 2nd version of the guidance on current issues related to the Covid 19 pandemic and clinical trials. +++
+++ On Friday 20 March 2020, Eudralex published guidance on current issues regarding the Covid 19 pandemic and clinical trials. +++
The Ethics Committees have not been spared the effects of the Sars-CoV-2 pandemic and current political measures. Of course, the ethics committees try to fulfil their tasks carefully and quickly despite all adversities, i.e. in compliance with the legal deadlines. However, in view of the threat posed by SARS-CoV-2, we ask for your understanding that, until further notice, all research applications relating to this virus or the corresponding disease will be processed with priority, both in accordance with the German Medicinal Products Act (AMG), the German Medical Devices Act (MPG) and the advisory procedure in accordance with § 15 of the Professional Codes for Physicians in Germany. In the second priority all other AMG and MPG studies will be processed. We assume that the deadlines can generally be met here. Should this not be the case in exceptional cases, we ask for your understanding that this was not possible due to external specifications and measures (force majeure).
It is clear to all parties involved that, in view of the possible restrictions of public life, the GCP-compliant conduct of clinical trials may also be affected. When decisions are to be made, it is first and foremost important to ensure the safety and well-being of the study participants. For example, the supply of investigational medicinal products in studies where patients are dependent on continuous therapy, e.g. in oncological studies or studies on the treatment of rare diseases, more generally speaking, studies with therapies for which there are no equivalent therapeutic alternatives, must be ensured. Ongoing studies should only be discontinued in exceptional cases and after careful consideration of ethical aspects. It should be remembered that patients have given their consent under the condition that only with the help of this study medically important questions can be answered. Should you come to the conclusion that the conduct of a clinical trial in accordance with the trial protocol can no longer be reliably guaranteed, a less intrusive option should be considered, e.g. a temporary stop of the recruitment of new trial participants. The recording of adverse events and effects and their transmission and evaluation must also be definitely guaranteed. In general, the relevant laws and regulations continue to apply. Thus, the responsible ethics committees must also be involved accordingly in upcoming decisions and modifications, e.g. of the trial protocol in terms of subsequent changes. § 11 of the GCP-V regulates the measures to be taken immediately, if necessary, to protect against immediate danger. It is recommended to document all deviations from the test plan that are due to the pandemic situation. Of course, all study patients should be informed without delay of any changes in the course of the clinical trial that are relevant to them
Of course you can always contact the ethics committee responsible for you with any questions that fall within the competence of ethics committees. We thank you for your understanding and remain hopeful that you will remain healthy and that the pandemic will be brought under control as soon as possible.
Important Information regarding the “Update Course” on EU Regulation No. 536/2014
The EU Regulation No. 536/2014 will significantly change the approval procedure and the conduct of clinical trials. An “update course” focused on this will enable doctors to prepare appropriately for the new legal situation. The Association of Medical Ethics Committees and the German Medical Associations will publish a corresponding curriculum at the beginning of 2020, which should serve as a root position for the relevant courses.