Read more explanation of CONSORT Item 7b

Examples of Interim Analyses and Stopping Guidelines

This page contains examples of CONSORT Item 7b - Interim Analyses and Stopping Guidelines.

You can submit your own Examples here.

Two interim analyses were performed during the trial. The levels of significance maintained an overall P value of 0.05 and were calculated according to the O’Brien-Fleming stopping boundaries. This final analysis used a Z score of 1.985 with an associated P value of 0.0471.
Galgiani JN, Catanzaro A, Cloud GA, et al. Comparison of Oral Fluconazole and Itraconazole for Progressive, Nonmeningeal Coccidioidomycosis. A Randomized, Double-Blind Trial. Ann Intern Med. 2000;133:676-86.

An independent data and safety monitoring board periodically reviewed the efficacy and safety data. Stopping rules were based on modified Haybittle-Peto boundaries of 4 SD in the first half of the study and 3 SD in the second half for efficacy data, and 3 SD in the first half of the study and 2 SD in the second half for safety data. Two formal interim analyses of efficacy were performed when 50% and 75% of the expected number of primary events had accrued; no correction of the reported P value for these interim tests was performed.
Connolly SJ, Pogue J, Hart RG, Hohnloser SH, Pfeffer M, Chrolavicius S, et al. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med 2009;360:2066-78.

Click this button to submit your own ExamplesHelp us to expand the Library of Examples by submitting your own.

Page last edited: 18 March 2011