The scale of the challenge posed by the coronavirus pandemic to the Sponsors and Investigators of clinical trials only continues to increase with the implementation of a UK-wide lockdown.
Fortunately, the MHRA aims to be "as pragmatic and flexible as possible with regards to regulatory requirements for clinical trials" during this period, although the safety of trial participants remains the MHRA's first priority.
Details of what the MHRA expects of those engaged in clinical trials during the pandemic are set out in new guidance issued last week. Here are our five key takeaways from the guidance:
- Storage Requirements - Does the medicine have any particular storage requirements? How will these be addressed during posting? Should a temperature monitoring device be used during transport?
- Delays in Posting - Would delays have the potential to affect continuity of supply?
- Medicine Accountability - What mechanism will be used to confirm trial participants have received the IMP? Should the IMP be sent "signed for" or by courier?
- IMP Administration - Do any of the trial participants require training in order to administer the IMP safely and correctly?
- Issues around confidentiality if there will be access to patients' Electronic Health Records away from the current trial site.
- The need to obtain consent from each trial participant before any associated identifier leaves the trial site and to ensure that trial participants are assured that their confidentiality will be protected.
- Avoiding the need for clinical staff to take on the extra burden of scanning and uploading of documents during this period of extreme pressure for the NHS.
- The use of alternative means of oversight such as teleconferences and videoconferences.
- patients being asked to avoid medical facilities due to the risk of infection; patients' reluctance to travel to areas with high population densities; and
- patients being under the requirement to self-isolate.
Although these deviations should be well-documented internally, the MHRA confirms that an increase in protocol deviations due to coronavirus will not constitute a serious breach unless patients are being put at risk.
There are no easy answers to many of the challenges which the sector is facing at this time, particularly by those responsible for structuring, managing and regulating clinical trials in the UK. However, this further guidance from the MHRA on what is expected of sponsors and investigators is a welcome development, as well as the MHRA's commitment to being as pragmatic and flexible as possible during these unprecedented times.
At VWV we are assisting a number of organisations across the pharmaceutical supply chain in dealing with legal and regulatory issues posed by the coronavirus.