When a clinical trial concludes, whether at its anticipated endpoint or prematurely, specific regulatory procedures must be followed to ensure transparency and compliance. The Medicines and Healthcare products Regulatory Agency (MHRA) mandates distinct reporting requirements depending on the circumstances of the trial's conclusion.
Early Termination Protocols
In instances where a trial is terminated before its planned conclusion, sponsors are obligated to inform the MHRA within 15 days of the global premature end. This notification is facilitated through the submission of the End of Trial Form. Alongside the form, a concise explanation detailing the reasons for the early termination, as well as any follow-up measures, must be provided. The Health Research Authority (HRA) also offers guidance on notifying other relevant bodies and managing post-research care.
Standard Trial Completion
For Clinical Trials of Investigational Medicinal Products (CTIMPs) not submitted via the Combined Review process, an End of Trial Form must be submitted to the MHRA within 90 days of the trial's global conclusion, as defined in the trial protocol. It's important to note that once the 'end of trial' has been declared, further substantial amendments to the trial are not permissible.
Post-Trial Requirements
Following the declaration of either early termination or standard completion, a Clinical Trial Summary Report must be generated within the timelines specified by the MHRA. This report provides a comprehensive overview of the trial's conduct and findings. The End of Trial Form must also be submitted to the ethics committee, with additional notifications required for NHS R&D offices and funders, adhering to local policies and procedures.
Non-CTIMP Research
For research not involving CTIMPs, direct notification to the relevant ethics committee is mandatory. A 'Declaration of the End of Study' form is available for this purpose.
These guidelines ensure that all clinical trials, regardless of their outcome or type, are properly documented and reported, maintaining the integrity and transparency of clinical research.
