Guidance on minimising disruptions to the conduct and integrity of clinical trials of medicines during COVID-19

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance for clinical trial sponsors to manage study conduct during and after the COVID-19 pandemic. The document transitions temporary pandemic-era flexibilities into permanent practice, focusing on decentralised methods and trial resilience. Key issues identified include overly prescriptive protocols, excessive exploratory endpoints, and data integrity risks arising from missing information or missed patient visits. The regulatory framework relies on MHRA and Health Research Authority (HRA) standards, alongside the ICH E9(R1) addendum for statistical integrity. Required actions for sponsors include: 1) Developing Standard Operating Procedures (SOPs) for telemedicine and home-based drug administration; 2) Implementing a risk-based approach to protocol deviations, allowing minor errors to be recorded at the trial level; 3) Conducting blinded risk assessments to evaluate pandemic impacts on data validity; and 4) Updating statistical analysis plans to account for intercurrent events or missing data. Sponsors are encouraged to utilize electronic health records for recruitment and consult the MHRA Clinical Trials Unit for fast-tracked advice on protocol amendments. This guidance serves as a proactive regulatory roadmap rather than a report on specific inspection dates or a single company violation.