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clinical trial endpoints

By Ethical 15 Sep, 2020

Complementary information in clinical trial endpoints adjudication: real-world feedback working as a quality enhancer

Endpoint adjudication of clinical trial endpoints by an independent expert committee is an operation that goes on during the entire length of a clinical trial. Regardless of the quality and completeness of the clinical trial endpoints adjudication charter, feedback from the field always reveals some necessary adjustments that can prove valuable to the overall quality of the trial.

To paraphrase a famous quote, “no plan survives first contact with the field”1. In spite of all the efforts to collect and transmit the appropriate clinical trial endpoints data to the endpoint adjudication committee in the fastest and most complete way, reviewers regularly notice missing or inconsistent data, require some clarification or need a complement of information.  In addition to clarifying adjudicated clinical trial endpoints, reviewers’ queries may reveal some intrinsic inconsistency in the clinical data or help identify missing information that should have been collected. In this respect, the adjudication process contributes to the overall quality of the trial. 
 
Good and fast communication between the site and the committee is therefore paramount for the timely assessment of clinical trial endpoints and since the committee must be totally blinded to the origin of the information, the endpoint adjudication platform and the endpoint office play a key role in the process. 

Within the adjudication process, the initial flow of information obeys standard rules applicable to all cases described in the study documents such as the adjudication committee charter. The complementary or updated information management however can prove much more complex, dealing with specific requests for data which have in principle been missed by the standard process. These data need to be located, extracted from the patients’ records and re-injected in the standard circuit in order to reach the reviewers and be incorporated in the adjudication process.

A well-thought adjudication platform for clinical trial endpoints should allow study coordinators to monitor the emergence of events and the progress of the adjudication process, to facilitate intermediary operations such as redaction and/or translation of documents, to identify outliers and to streamline the process of assessment. It should also connect the sites with the adjudication committee ensuring the blinding of all identifiers, preserve data integrity and confidentiality and guarantee compliance by recording all actions in a secure audit trail.

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1Helmut von Molkte, Prussian military commander 1800-1891, Oxford Essential Quotations (4 ed.), Oxford University Press, eISBN: 9780191826719

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