Disease relevance of Clinical Trials Data Monitoring Committees

• RESULTS: On May 31, 2002, after a mean of 5.2 years of follow-up, the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits [1].

High impact information on Clinical Trials Data Monitoring Committees

• RESULTS: The study drug administration was stopped early in accordance with a recommendation from the Independent Data Monitoring Committee because of higher mortality in the group treated with epoetin alfa [2].
• Indeed, an independent Data Monitoring Committee determined that both trials exceeded the prespecified efficacy value of P<.0015, recommending that the trials be discontinued and that lenalidomide be offered to patients on the dexamethasone arm of the trial if clinically indicated [3].
• The Data and Safety Monitoring Board recommended discontinuation of the clarithromycin dosage comparison and continuation of the rifabutin vs. clofazimine comparison [4].
• An introductory note to CHMP guidelines: choice of the non-inferiority margin and data monitoring committees [5].
• This paper, using the Nocturnal Oxygen Therapy Trial as an example, discusses three issues often faced by data monitoring committees [6].

Associations of Clinical Trials Data Monitoring Committees with chemical compounds

• RESULTS: After a mean follow-up of 5.2 years (planned duration, 8.5 years), the data and safety monitoring board recommended terminating the estrogen-plus-progestin trial because the overall risks exceeded the benefits [7].
• FINDINGS: The iron and folic acid-containing groups of the study were stopped early in November, 2003, on the recommendation of the data and safety monitoring board; mortality in these groups did not differ from placebo and there was low power to detect positive or negative effects by the time enrollment was completed [8].
• The independent data and safety monitoring board recommended offering open-label emtricitabine based on the interim analysis [9].
• The amodiaquine group was stopped early by the data and safety monitoring board [10].
• A scheduled review by the data and safety monitoring board with the use of prespecified stopping boundaries led to a recommendation to stop the triple-nucleoside group and to present the results in the triple-nucleoside group in comparison with pooled data from the efavirenz groups [11].

References