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The other side of clinical trial monitoring; assuring data quality and procedural adherence

Amgen, Inc., Thousand Oaks, California, USA, gewillia{at}amgen.com

Background Data monitoring can mean different things. It can mean statistical methodologies for clinical trial monitoring, interim data analysis, monitoring for quality control or assurance or safety reporting to regulatory agencies.

Purpose The various facets of data monitoring will be discussed and reviewed from primarily an industry perspective.

Methods By careful attention to the design and conduct of a clinical trial, the expense of monitoring can be markedly reduced. Careful attention should be given to the qualifications of investigators in the selection of clinical sites and central facilities. Site personnel must be adequately trained. The sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial. The monitor should visit the investigator at the site of the investigation frequently enough to ensure acceptable quality. The monitor is responsible for inspecting the case report forms at regular intervals. Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly. The auditor will assess whether the site is being monitored in accordance with the monitoring plan. The determination of the extent and nature of monitoring should be based on considerations such as the objective, design and complexity of the trial. Statistical sampling may be an acceptable method for selecting the data to be verified. The monitor should ensure that adverse events are reported. Study data will be monitored on an ongoing basis to ensure patient safety. The sponsor may utilize a Data Monitoring Committee to protect the validity of a trial.

Conclusions Discussions between industry, academia and regulatory groups regarding the optimal extent and methods for monitoring of clinical trials are encouraged.

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