The Clinical Trials Regulations require the sponsor to notify the ‘End of Trial’ to competent authorities (MHRA in the UK) and ethics committees of all member states concerned, within 90 days. The EudraCT Declaration of End of Trial Form (PDF, 26 KB) should be completed.
Definition of the End of Trial
The forthcoming EU Clinical Trials Regulation will provide a definition for the End of Trial and also require the definition to be included in the protocol:
‘End of a clinical trial means the last visit of the last subject, or at a later point in time as defined in the protocol’
Standard Operating Procedures for Research Ethics Committees (RECs) within the UK Health Departments’ Research Ethics Service (V 7, Section 10.98) provide additional clarity:
‘The end of the research should be defined in relation to the collection of all data required to answer the research questions in the protocol. Where a clinical trial protocol requires follow-up monitoring and data collection to meet secondary or tertiary endpoints, the end of trial should be the final data capture rather than the last treatment visit’.
Note: The EU term ‘End of Trial’ corresponds to the term ‘Study Completion Date’ utilised by draft US Food and Drug Administration Amendments Act, required by ClinicalTrials.gov, and adopted by the AllTrials Campaign.
‘Study Completion Date: Final date on which data was (or is expected to be) collected’.
Note: Many registries encourage the contemporaneous posting of interim results at the time of the analysis, in addition results from the final analysis.
Once the end of trial has been declared, no further substantial amendments are possible and a Clinical Trial Summary Report must be produced as detailed in the Clinical Trial Summary Report station).
For UK trials, the process for notification to the MHRA is detailed on their web pages. The HRA web site offers guidance for reporting to the ethics committee. NHS R&D offices will also require notification in accordance with local policies/procedures.
For multi-national trials, the end of trial form should only be submitted when the trial has ended in all countries. However, the MHRA may be informed by letter/e-mail when the trial finishes in the UK which will signal the suspension of the annual service fee for maintaining the Clinical Trial Authorisation.
For non-CTIMP research, notification to the relevant ethics committee is required. The ‘Declaration of the End of Trial Form’ is available from the HRA web site and should be used.
It is important to note that funders will not regard this as the end of the project and will require additional reporting and requirements. However, it is important to update them on developments and activities such as those listed above.
- In England, R&D organisations may use elements of the guidance provided in Annex 4 and 5 of the Research Support Services Framework documents: