UPDATED ON April 22nd, 2020
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on the management of clinical trials in response to the COVID-19 pandemic.
“The MHRA will be as flexible and pragmatic as possible with regard to regulatory requirements for clinical trials during this time. We recognise that clinical trial resource may be absent or redeployed from research activities and regulatory affairs towards front-line care. The first priority should be the safety of trial participants and this will remain MHRA’s focus.”
MHRA is reachable through firstname.lastname@example.org or 020 3080 6456, with highest priority given to COVID-19 requests.
The new MHRA guidance provides information on several topics:
- Managing ongoing and halted trials
- Submitting paperwork for trials which have been halted
- Providing investigational medicinal product (IMP) to trial participants
- Accountability of Investigational Medicinal Products (IMP)
- Remote monitoring for trials
- Changes to the number and type of participant monitoring visits
- ‘Dear Investigator’ Letters
- Reporting of serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and submission of annual safety reports (DSURs)
- Protocol deviations and serious breaches
- Protocol waivers
- Urgent Safety Measures
- Participant safety
- Help from the MHRA
Among others, the document states that protocol deviations as a result of COVID-19 do not need to be reported unless patients are at risk.
Moreover, the document includes important measures regarding trial halting, investigational medicine products delivery to patients, monitoring activities.
In-person visits can be replaced by phone calls, where possible.
Monitoring activity change
The guidance encourages the use remote monitoring through teleconferences/videoconferences for monitoring. Patient data protection and consent to unconventional use of patient data is also addressed.
March 24th, 2020: Sections on protocol deviations and serious breaches, protocol waivers, subject safety and signatures have been added.
Find the MHRA guidance at this link
April 2nd, 2020: The MHRA updated guidance for industry on their flexible approaches to regulation.
Any new or ongoing study that is not a nationally prioritized COVID-19 study will be paused.
MHRA and HRA will endure to provide an approvals service for all studies, prioritized in accordance with the national situation, ensuring site set-up can restart promptly in due course.
April 8th, 2020:
MHRA provided additional information in ‘Medicines regulation’ section for flexibility on labelling, as well as the limit for replies to questions on Type IB variations and the extension of the 30-day national phase for DCP CMS.
April 16th, 2020:
April 21st, 2020:
Clarified what information the MHRA needs from manufacturers and wholesalers about when they use flexibilities, and in what circumstances this information should be sent to us. This is in the ‘Inspections and good practice’ section
April 22nd, 2020:
Added content on accountability of investigational medicinal products and urgent safety measures, and updated guidance around managing ongoing and halted trials, remote monitoring and signatures.
Meditrial can help – Contact us for immediate support
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures