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Clinical Trial Management Guidelines under Covid-19 – Europe
Good Clinical Practice (GCP) is referred to an internationally acclaimed ethical and scientific quality standard for designing, recording and reporting trials involving participation of human subjects. Compliance with this standard assures the protection of trial subjects and increases the credibility of clinical trial data.
Maintaining consistency with the Declaration of Helsinki ensures complete protection to clinical trial subjects. This statement regarding ethical principles was developed by the World Medical Association.
Guidelines pertaining to the conduct of clinical trials in the European Union (EU), covering GCP and good manufacturing practice (GMP) and GCP or GMP inspections, are present in:
- the ‘Clinical Trial Directive’ (Directive 2001/20/EC);
- the ‘GCP Directive’ (Directive 2005/28/EC).
The Heads of Medicines Agencies contains all necessary information regarding EU Member State activities such as:
- Guidance on clinical trial management during the COVID-19 pandemic
- Guidance for clinical-trial sponsors on how they should adjust the management of clinical trials and participants during the COVID-19 pandemic
It includes instructions on how such unusual situations that come with pandemic can be easily handled. Some of these instructions are:
- Self-isolating or keeping trial participants in quarantine.
- Limiting their access to public places such as hospitals to reduce the spread of infections
- Reallocating healthcare professionals.
- Measures are even provided on the ways to communicate such changes to competent national authorities.
| An update to this guidance on 28 April 2020 provided additional flexibility and clarification on:The distribution of medicines to trial participants. This takes into account social-distancing measures and possible limitations in trial site and hospital resources;The remote verification of source data (SDV) in the context of social distancing measures. This aims to facilitate activities that support the approval of COVID-19 and other life-saving medicines;Notifying authorities of urgent actions taken to protect trial participants against an immediate hazard, or of other changes taken to support patient safety or data robustness.European Commission: Coronavirus: Commission issues guidance to mitigate clinical trial disruption in the EU |
The guidance also specifies certain advice on clinical trials for treating COVID-19, including the requirement for bigger, multi-national trial protocols. This is an extension to CHMP’s call urging the EU research community to prioritize large randomized controlled clinical studies as these are supposed to generate some conclusive evidence needed to enable rapid development and approval of potential COVID-19 treatments. It has made it clear that the participation of all EU countries is a necessity in these trials (CHMP statement: A call to pool EU research resources into large-scale, multi-centre, multi-arm clinical trials against COVID-19).
A special note that has been issued by the authority mentions that “Member States are encouraged to implement the harmonised guidance to the maximum possible extent to mitigate and slow down the disruption of clinical research in Europe during the public health crisis. At the same time, sponsors and investigators need to take into account that national legislation and derogations cannot be superseded. Member States shall complement the guidance to create additional clarity on specific national legal requirements and derogations to them.”
Clinical trials are authorized and supervised at national level in the EU, hence it is necessary for sponsors to check whether relevant national legislation and guidance are in place to complement or, in some cases, to prioritize the guidance.
The Clinical Trials Expert Group (CTEG) of the European Commission agreed to the guidance and EMA provides its complete support along with the Clinical Trials Facilitation and Coordination Group (CTFG) of HMA and the GCP Inspectors’ Working Group. They together aim to ensure utmost safety of trial participants across the EU and at the same time preserve data quality.
