UPDATE ON March 24th, 2020
The Agency is aware of Covid-19 influence on the conduct of clinical trials in Denmark and takes into account multiple factors such as trial participants in quarantine or limited access to hospitals due to the risk of spreading infections.
The requests regarding Covid-19 are prioritized.
A dedicated email has been set up for all the questions related to clinical trials. The subject field should contain ‘COVID-19’. This email is not for approval requests or trial changes.
There is also a helpline (4488 9123) for all clinical trial conduct queries.
Changes in monitoring
The monitoring of clinical trials needs to be adjusted to the current crisis and all the decisions should be driven based on patient safety.
Risk assessment measures should take into consideration whether recruitment should be stopped temporarily. Besides, the agreement with investigator sites on any changes should be obtained.
- On-site monitoring can be carried out to the extent possible, as agreed with the investigating facilities. If it is not possible to comply with the on-site monitoring plan, monitoring should be supplemented with centralized monitoring and central review of data.
- The Sponsor of a clinical study should assess whether trials should be put on a temporary halt, and notify the authorities if decided to do so.
Changes in visits or trial participants’ affiliation to an investigator site
The Agency recommends taking into consideration the transfer of trial subjects to a different site (new or existing one) in less affected areas.
Sponsors shall consider whether physical visits can be converted to phone visits, postponed or canceled completely to ensure that only strictly necessary visits are performed at sites. This consideration should also be part of the sponsor’s risk assessment concerning the COVID-19 pandemic.
Special precautions for First in Human trials:
The Agency expects that all FiH trials will be put on hold. Specifically, this means that recruitment for such trials should be halted. New trials should not be initiated and, for ongoing trials, higher dose levels than already initiated should not be started.
March 24th, 2020: Medicines Agency amends guidance on clinical research under COVID-19.
Meditrial can help, Contact us now
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions:
- 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