Importance and role of independent data monitoring committees (IDMCs) in oncology clinical trials.

ABSTRACT: The role and use of independent data monitoring committees (IDMCs) has evolved over the past decades. The Food and Drug Administration and European Medicines Agency have issued guidelines on the role and functioning of such committees. In general, data monitoring committees are recommended for large, often randomised clinical trials involving life-threatening diseases, studies performed in vulnerable populations or where the experimental intervention can potentially harm the trial participant. Such committees play an important role in trials evaluating treatments with the potential to prolong life or reduce the risk of major adverse health outcomes.Typically, oncology clinical trials fall within these recommendations, as they are often large, randomised, multicentric protocols aiming at im

SUBMITTER: Schoffski P 

PROVIDER: S-EPMC8547363 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature