Coronavirus (COVID-19): impact on the conduct of clinical trials under the Medical Research Involving Human Subjects Act (WMO)
The COVID-19 pandemic affects health care services and the society in general. The conduct of clinical trials and trial subjects participating in clinical trials might be affected as well. The situation evolves and pragmatic measures might be required to manage the situation regarding the conduct of clinical trials and to ensure the rights, safety and wellbeing of trial subjects.
Note: If needed, the information given below may be adjusted. Please check our website and the information given by other parties (see hyperlinks below) regularly for updates.
In order to mitigate the negative impact on the conduct of clinical trials during the period of the COVID-19 pandemic, a European Guidance has been developed. This Guidance is applicable for all parties involved in the conduct of clinical trials conducted in one of the member states of the European Union/European Economic Area (EU/EEA).
Additionally, the Central Committee on Research involving Human Subjects (CCMO) formulated several recommendations on her website. In some cases, investigators and sponsors need to inform the review committee (CCMO or MREC/IEC).
The IGJ emphasises that national legislation (like the WMO and Medicines Act) sometimes prevails over the European Guidance. Points to be considered are related to e.g. not complying to the study protocol, the informed consent process, the protection of personal privacy as a result of replacing physical visits by telephone, email and/or app. Furthermore the DSUR might be at risk to be incomplete or trial subjects receive their IMP directly form the (hospital) pharmacy.
The IGJ expects that investigators and sponsors take good notice of the Guidance and any deviation in procedures related to the clinical trial due to the COVID-19 pandemic will be documented adequately. A proportionate approach will be taken by the GCP inspectors when such deviations are reviewed during inspections.