Clinical trials & regulation

The BIA is liaising closely with UK regulators, the National Institute for Health Research (NIHR) and the Department of Health and Social Care (DHSC). The following is official guidance on the management of clinical trials and clinical trial applications during the COVID-19 outbreak.

Restarting clinical trials paused due to COVID-19

NIHR has issued guidance on protecting research during a 'second wave' of COVID-19. This includes staff funded by NIHR not being deployed to frontline duties, and maintains the study priortisation levels set out in May.

On 19 March the NIHR paused the set-up of new or ongoing clinical trials at NHS sites that are not nationally prioritised COVID-19 studies to enable the NIHR research workforce to focus on delivering nationally prioritised COVID-19 studies or redeployment to frontline care where necessary.

The BIA called on the Government to develop a plan for restarting non-COVID-19 clinical trials, given the impact that paused studies have had for patient participants, BIA member companies and the life sciences sector. We welcomed the letter of 6 May from the Chief Medical Officers and NHSE Medical Directors to the NHS about recruiting patients into clinical trials for COVID-19 therapeutics, highlighting that a lot of other valuable research is being undertaken across the health and care system.

The BIA has also inputted into the NIHR consultation to inform a DHSC/NIHR ‘Restart Plan’ for paused studies, the commencement of new clinical trials and the prioritisation of resources in the NIHR Clinical Research Network and NIHR infrastructure more broadly. This plan - due to be published soon - will have a direct benefit of improving patient access to innovative medicines, and fits well with member companies’ planning work to date.

MHRA guidance for industry

MHRA has published a new information hub containing their latest news and information relating to COVID-19. This includes new Advice for Management of Clinical trials in relation to Coronavirus.

Where trials need to be temporarily halted due to COVID-19 related capacity or capability reasons, MHRA would not expect to be notified of trial halts. The trial master file should include a note that the trial was halted and the reason.

However, if the halt is a result of a direct participant safety incident, particularly if this has potential to impact participants of other trials, or as a result of a medicines supply issue then MHRA should be informed in the normal way. This can be done via email to the MHRA helpline rather than via an amendment form.

If the restart of the study does not involve any substantial changes to the Clinical Trial Authorisation (CTA), then a substantial amendment notification to MHRA will not be necessary. If changes do need to be made to protect participant safety moving forward, then this should be submitted as a substantial amendment in the normal way.

Alternative arrangements for patient supply of investigational products e.g. posting of the medicine rather than clinic attendance, does not require prior notification to MHRA, however appropriate risk assessments should be in place.

Remote monitoring is supported by MHRA where appropriate and practical.

HRA guidance for sponsors, sites and researchers

The Health Research Authority has also produced new guidance for sponsors, sites and researchers about the COVID-19 pandemic. The guidance covers the setup of new studies, amendments to existing studies and changes being made by sponsors at this time.

Impact on National Institute for Health Research (NIHR) research

The NIHR has issued new guidance that all non-COVID NIHR funded studies in the set-up process will be suspended. This does not impact on MHRA/HRA approval processes – trials which have been approved will be paused and be ready to start as soon as possible after the pandemic.

On 26 March the NIHR introduced a single, national process to prioritise COVID-19 studies which hold the most potential for tackling the challenges faced, as part of the Government’s response to the pandemic. This process will cover funded studies, irrespective of the source of funding – whether by the public sector, industry or charities and also, in partnership with UKRI, studies that require funding. All NHS Trusts, healthcare providers and universities will need to prioritise support for studies which have been nationally prioritised. A live list of these studies, which includes 3 commercial studies, will be regularly updated.

Details of the new arrangements and the new single point of entry are published on a dedicated COVID-19 page on the NIHR website.

NICE guidance

NICE is publishing a series of rapid guidelines on the active management of COVID-19 infection. The first 3 cover the management of patients in critical care, the management of patients who are having kidney dialysis and the management of patients who are receiving systemic anticancer treatments.

EU Guidance on the Management of Clinical Trials during the COVID-19 pandemic [updated 30 March]

The EU has published updated EudraLex-10 Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic. The update covers safety reporting, the distribution of in-vitro diagnostics, medical devices and auditing. It also incorporates changes in other sections, in particular on communicating with authorities, informed consent and the distribution of investigational medicines.

Other relevant guidance

The Health Research Agency (HRA) has existing guidance on research in a public health emergency

ACRO’s has published recommendations to Support Clinical Trial Monitoring Oversight During COVID-19

The FDA has also produced Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

Update on the NIHR/NICE/NHSE/MHRA ‘Research to Access Pathway to Investigational Drugs’ initiative: RAPID-C19

The BIA has been in contact with NHS bodies who have confirmed that a process is being put in place to deliver rapid access to medicinal technologies to treat COVID-19. Working with the other trade associations we have summarised the planned process here. We will also be working with NHS bodies, including NICE and MHRA, to ensure that members’ concerns on a range of issues, including reimbursement and manufacturing, are being considered.

For further information or advice on clinical trials and regulation related to the COVID-19 outbreak, please email Christiane Abouzeid

Resources and further information

Following engagement with the BIA and other industry organisations, the MHRA has provided a catalogue of finalised regulatory flexibilities that are already in place to help the sector deal with pressures related to COVID-19

MHRA Clinical Trials Unit Helpline [email protected] or 020 3080 6456 will give inquiries relating to COVID19 the highest priority, including the possibility for fast-tracking submissions.

NICE guidance and resources on Covid-19

The MHRA have announced new arrangements for MHRA Good Practice (GxP) inspections due to coronavirus (COVID-19)

The DHSC has stood up the National Supply Disruption Response to monitor the supply situation and co-ordinate actions to address any incidents of supply disruption where normal procedures are unable to provide a resolution. Marketing Authorisation holders will have received guidance directly from the Department today. They can be contacted at: 0191 283 6543 and at [email protected]

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