Clinical Trial Monitoring Task
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A Clinical Trial Monitoring Task is a clinical trial oversight task that monitors participant health and efficacy of the treatment during a clinical trial.
- Context:
- It can be supported by a Clinical Trial Monitor Worker.
- …
- Example(s):
- See: Risk-based Monitoring.
References
2021
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Monitoring_in_clinical_trials Retrieved:2021-12-22.
- Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial. Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) and the World Health Organization (WHO), require data and safety monitoring protocols for Phase I and II clinical trials conforming to their standards.
1999
- (DeMets et al., 1999) ⇒ David L. DeMets, Stuart J. Pocock, and Desmond G. Julian. (1999). “The Agonising Negative Trend in Monitoring of Clinical Trials.” The Lancet 354, no. 9194
- ABSTRACT: Randomised clinical trials are undertaken in the hope of showing positive benefits of a new treatment, but on occasion quite the opposite trend can occur, if the interim data suggest possible negative (harmful) effects of a new treatment. The handling of such emerging negative trends is among the most complicated and ethically challenging scenarios in monitoring clinical trials through repeated interim analyses. Statistical methods are helpful to detect the point of no likely beneficial effect, and the point that separates neutral results from harmful results. However, in practice the decision whether (and exactly when) to stop such a trial involves a complex of other issues that depends on the context of the disease, the treatment being assessed, and the current practice of medicine. Owing to this complexity, an independent Data and Safety Monitoring Board (DSMB) is best suited to deal with such a situation. Prediction of whether a negative trend will emerge in any trial is not possible. Negative trends were not anticipated in the cardiovascular trials and the trials of lung-cancer prevention described here. In the light of these experiences, all trials and their DSMBs should consider ahead of time the possibility of unexpectedly harmful results, and should document appropriately the statistical guidelines and the decision-making process required to cope with such undesirable events.