Clinical research is facing unprecedented challenges due to COVID-19. For ongoing clinical trials, the protection of patients, integrity of research data, and oversight of operations must be maintained as carefully as possible. We are working with each trial sponsor to evaluate risks and establish appropriate procedures and mitigations.
In response to the current situation, the European Commission published a guidance on the management of clinical trials during the COVID-19 pandemic. Although the guidance strongly refers sponsors and investigators to the national legislation applicable to the country where clinical research takes place, it also provides direction to any changes or considerations that might need to be made as a result of the virus outbreak.
The primary action that should be taken by sponsors is to conduct an assessment of how the COVID-19 situation is impacting their clinical trial, what the risk is for patients and the trial, and what needs to be communicated to regulatory authorities. We are currently undertaking this with our clients, while in addition, we’re reviewing the European Commission guidance on initiating new trials, possible changes to ongoing trials, and any further guidance they’ve provided.
Changes to ongoing trials:
COVID-19 may be impacting ongoing trials in several ways: patient recruitment, conduct of follow-up visits, study duration, etc. The sponsors should consider in their risk assessment which of the following measures could be appropriate during COVID-19 and then generally be agreed upon with investigators: conversion of physical visits into phone or video visits; temporary halt or closing of the trial at some or all sites; suspension or slowing down of patient recruitment; extension of the duration of the trial; transfer of some or all study activities to other investigational sites.
Any such changes can be considered by the sponsor or may be initiated by the investigational sites. Many European countries have now shared national guidance on communication to National Competent Authorities and Ethics Committees, for situations where changes are made to the clinical trial as a result of COVID-19. If such changes need to be implemented, it is crucial to inform the National Competent Authority and the Ethics Committees as applicable per the national legislation or guidance.
Initiating new trials:
The European Commission directs that feasibility of starting a new clinical trial or including new trial participants in an ongoing trial should be critically assessed by sponsors. Additional risks to participants should be addressed in the risk benefit section of the protocol along with risk mitigation measures.
In addition to this, we see that some investigational sites have halted the initiation of new clinical trials at the moment, while clinical departments less affected by COVID-19 are actively seeking to conduct the work involved in clinical trial preparation now, in order to be able to start the trial when clinical practice is back to usual. This could really be anything from protocol design or (remote) site qualification visits to the preparation of trial applications.
In summary, for ongoing trials, it is of utmost importance to conduct a proper risk assessment and keep authorities informed, while for new trials it might well be the right time to start involving potential investigators and developing your protocol, or putting the finishing touches on your design in order to get everything ready for trial initiation. Should you seek support for either one of these situations, please feel free to contact us.