Managing clinical trials during Coronavirus (COVID-19)

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued this guidance to manage clinical trials disrupted by the COVID-19 pandemic, aligning with the 2020 NIHR Restart Framework. The regulatory framework emphasizes participant safety and pragmatic flexibility, addressing challenges such as staff redeployment, restricted site access, and potential interactions between investigational medicinal products (IMP) and COVID-19 vaccines. Sponsors and host organizations are required to perform trial-by-trial risk assessments to determine whether to continue, adapt, or halt recruitment. Main issues include the need for remote monitoring, disruptions to medicine supply chains, and the impact of social distancing on protocol compliance. Required actions for sponsors include implementing remote electronic health record access with strict security measures, facilitating home delivery of IMPs where necessary, and documenting protocol deviations clearly in Trial Master Files. While minor adaptations like switching to phone-based monitoring do not require formal notification, substantial amendments must be submitted for significant safety concerns, medicine shortages, or when restarting trials previously halted through regulatory channels. Urgent Safety Measures should be used for immediate health hazards, and standard safety reporting for serious adverse reactions must continue via established routes to ensure ongoing oversight and data integrity.