The HRA is taking a three-pronged approach to studies, providing guidance on:
- New studies relating to COVID-19, including procedures for expedited review.
- Amendments to existing studies to address COVID-19 elements, such as adding sub-studies or components to enable epidemiological analysis of COVID-19, or to add patients with COVID-19 to an existing trial.
- Amendments to existing studies impacted by the wider COVID-19 response, such as sponsors making changes to how or when patients are seen (to avoid exposing patients or to reduce burden on clinical services), investigational medicinal product (IMP) being sent by courier direct to participants, or halting / closing studies.
The HRA guidance is aimed at clarifying the procedures for sponsors and sites to follow in these scenarios, including how to notify relevant sites and how expedited review processes will work. We’ve set out a summary of the HRA guidance below.
The MHRA’s guidance addresses a range of issues. We’ve honed in on a few of these in our summary below, including:
- the MHRA prioritising COVID-19 assessments.
- providing IMP to trial participants.
- remote monitoring for trials.
The guidance is moving quickly in this area and the authorities are updating these resources regularly. We recommend checking the guidance regularly for further developments.
HRA Guidance: Summary
New studies relating to COVID-19
There is an expedited review process available for studies relating to COVID-19 where there are public health grounds for rapid review. The process for fast-track reviews is set out in the Standard Operating Procedures for Research Ethics Committees.
The Confidentiality Advisory Group also provides an expedited review for studies that will involve use of confidential patient information without consent.
Amendments to existing studies to address COVID-19 elements
Studies may need rapid amendment to address Covid-19, such as adding sub-studies or components to enable epidemiological analysis of COVID-19, or to add patients with COVID-19 to an existing trial of a treatment. If this is the case:
- All amendments requiring submission should use the usual email route, but must be clearly marked as advised by the HRA, so they may be expedited.
- For non-substantial amendments, the template non-substantial amendment form may still be used.
Amendments to existing studies impacted by wider COVID-19 response
The HRA acknowledge that there are a number of scenarios where sponsors and sites need to rapidly amend an existing study with no COVID-19 related aspects. This may be due to the wider impact of COVID-19 on NHS staffing, restrictions on movement of people, or in response to UK Government advice.
Safety of patients remains a priority. Sponsors may need to consider discontinuing participants if the safety of a participant is at risk because they cannot complete key safety checks. Where necessary, the HRA recognises that urgent safety measures may be implemented first and notified subsequently.
The HRA has provided guidance on what to do if:
- sponsors need to change their site monitoring arrangements, or make changes to administrative arrangements to reduce burden or physical contact with sites.
- sponsors need to make changes to how or when patients are seen (to avoid exposing patients or to reduce burden on clinical services).
- treatment or IMP need to be sent by courier direct to participants.
- sponsors need to implement a temporary halt to all or some of the study, or extend the duration of a study.
- studies need to be closed.
- sites need to suspend recruitment.
- sites need to move participant visits due to re-allocation of staff and resources to clinical care or limiting participant contact.
- sites need to withdraw participants.
- Principal Investigator(s) are taken off a study.
MHRA Guidance: Some key issues
The MHRA prioritising COVID-19 assessments
The MHRA set out its procedures for rapid scientific advice, reviews and approvals. The MHRA has promised dedicated resources to ensure this happens, as the MHRA did during the Ebola crisis when it authorised clinical trial applications within a week.
Providing IMP to trial participants
If a trial participant cannot attend the site, then delivery of IMP to a patient’s home is acceptable and no substantial amendment notification to the MHRA will be required. However, sponsors should still carry out a risk assessment and record this internally. Participants must consent verbally (and this should be documented) to provide contact details for shipping purposes. If the participant does not want to sign for the delivery due to self-isolation, then a follow up phone call could be used to confirm they have received the delivery. Key factors for sponsors to consider include storage requirements, delays in posting and medicines accountability.
Remote monitoring for trials
The MHRA supports remote monitoring where appropriate, but requests sponsors to consider the following issues:
- confidentiality of patient records if there is direct access to patients EHR (Electronic Health Record) away from the site.
- trial participants will need to consent to any identifiers leaving the site and be assured that their confidentiality will be protected.
- increased pressures on clinical staff during this period, so it is important to make sure that extra burdens are not placed on investigators e.g. scanning and uploading many documents.
- alternative means of oversight such as teleconferences/videoconferences is encouraged.