MHRA Guidance On Clinical Trial Conduct During COVID-19 Pandemic
The MHRA Inspectorate have been active in posting guidance about the COVID-19 outbreak. They have posted a blog: Advice for Management of Clinical trials in relation to Coronavirus. The MHRA anticipates a rise in protocol-related deviations in ongoing clinical trials as a result of disruptions caused by the COVID-19 outbreak. As a result of the pandemic, patients may be advised to stay away from hospitals and other health sites, or they may be reluctant to travel or they may be advised to self-isolate, which may result in them being unable to undertake required clinical trial activities.
Additionally, organizations managing and sponsoring clinical trials may be experiencing a higher proportion of staff working from home during this period. “This has led to reports of protocol and standard operating procedure deviations due to missed visits, or changes in processes… Wet-ink signatures have also been difficult to obtain in a timely manner if staff are not in the office, and this can delay some clinical trial processes,” the MHRA said.
The MHRA followed with a second blog: https://mhrainspectorate.blog.gov.uk/2020/03/20/mhra-guidance-on-coronavirus/ which covers Managing Clinical Trials and Clinical Trial Applications and address issues such as paperwork for temporary halts, providing IMP by post, and remote monitoring. There is also guidance on GxP inspections during the pandemic: https://mhrainspectorate.blog.gov.uk/2020/03/23/mhra-good-practice-gxp-inspections-during-the-covid19-outbreak/
Things To Consider:
- Any increase in protocol deviations in relation to coronavirus “will not constitute a serious breach” and should not be reported to the MHRA, unless there is a risk to patients.
- All deviations must be well documented to enable appropriate evaluation for the trial in the future.
- Oversight duties in hospital settings should be reassessed, such as monitoring and quality assurance activities
- A brief risk assessment should be performed and documentation of the impact of this, with consideration of prioritization of critical activities such as safety reporting.
- Introducing remote monitoring while ensuring this does not place an extra burden on trial sites. The trial subjects should consent to sharing of their personal information outside the trial site prior to this activity taking place.
- Alternative methods of demonstrating approvals (in place of wet-ink signatures) such as email confirmation are acceptable
- Prospective protocol waivers in relation to inclusion or exclusion criteria, or to give a site pre-approval to deviate from protocol-defined visit window are not acceptable.
- If the safety of a trial subject is at risk because they cannot complete key evaluations or adhere to critical mitigation steps, then consideration to discontinuing that subject must be discussed.
- The sponsor and investigator have the authority to use “urgent safety measures” or even temporarily halt a trial, or halt recruitment, where necessary.
MHRA are prioritising and expedited review of COVID-19 CTAs
- As requested by the WHO COVID-19 should be entered in the title field of the trial registration data set (Annex 1 XML)
- COVID-19 applications should be submitted directly to the Clinical Trial Helpline by emailing email@example.com,
- MHRA GxP inspectorate will prioritise COVID-19 and inspections will take place remotely in most cases
The NHS has released a guidance document as well titled COVID-19: Guidance for sponsors, sites and researchers.
- The MHRA are prioritizing COVID-19 related studies so submissions and amendments for other studies may be delayed
- The MHRA is aware of challenges arising in relation to coronavirus and the effect this was having on the conduct of clinical trials.
- The Agency says that any increase in clinical trial protocol deviations in relation to coronavirus outbreak will not constitute a serious breach.
- Veristat should evaluate if alternate procedures need to be put in place as a result of the virus’s impact on normal business and ensure that all decisions and risk assessments are well documented.
More COVID-19 Resources:
- Explore the Veristat COVID-19 Resource page
- Read our infographic to Understand FDA Expedited Pathways for Accelerating Time-to-Market for Products Treating Serious Conditions or Unmet Medical Needs
- Download the Infographic explaining the Types of FDA Meetings with CDER and CBER
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