Closing down a trial
It is easy to neglect the importance of proper trial ‘close-out’ activities in the excitement of finalizing data collection and proceeding to analysis. However a planned and managed close-out of a clinical trial is vitally important.
Key outcomes from proper trial close-out:
- Complete (or as complete as possible) and accurate data collection
- Secure archiving of trial material – especially patient data and samples.
- Compliance with legal and ethical requirements
- Review of the trial experience – draw lessons to improve future trials.
As the end of the trial approaches, a planned sequence of activities are needed. This should begin with completing all outstanding data queries and checking data completeness, including adverse event collection and reporting. Tasks should be divided between sites and central coordinating centers (for multicenter trials). Each will need to ensure that all relevant documentation (such as case report forms, consent forms, adverse event forms, etc.) is identified and archived so that it can be retrieved if needed for audit or to inform later analyses. Study material such as investigational drugs (including placebos) need to be accounted for and, where necessary, disposed of appropriately. Study close-out also involves the notification of staff at sites and of the necessary regulatory bodies and updating the clinical trials registry.