Design issues in pivotal drug trials for drug sensitive tuberculosis (TB)
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High-dose rifapentine with or without moxifloxacin for shortening treatment of pulmonary tuberculosis: Study protocol for TBTC study 31/ACTG A5349 phase 3 clinical trial
2020, Contemporary Clinical TrialsCitation Excerpt :For the current study, the 6.6% margin of non-inferiority preserves >50% of the above 19.3% M1 estimate. Considering the clinical argument [58,59], the investigators for the current study, in broader consultation within the two large publicly-funded international consortia of TB stakeholders that participate in the current study (CDC TB Trials Consortium and NIH AIDS Clinical Trials Group), consider the benefits of a shortened rifapentine-based regimen to justify the margin of 6.6%. Study investigators consider 600 patients per arm sufficiently large to provide adequate precision on the difference in efficacy between the regimens to determine whether an intervention regimen might be considered not inferior to the control regimen.
New antituberculosis drugs, regimens, and adjunct therapies: Needs, advances, and future prospects
2014, The Lancet Infectious DiseasesCitation Excerpt :If results are promising, this combination might lead to the development of a phase 3 pivotal trial. The novel multiarm multistage (MAMS) trial design compares several regimens simultaneously.78–80 Planned interim analyses act as intermediate checkpoints and are used to compare the experimental groups with common controls.
Moxifloxacin for tuberculosis
2012, The Lancet Infectious DiseasesDetermining the minimum duration of treatment in tuberculosis: An order restricted non-inferiority trial design
2023, Pharmaceutical StatisticsNoninferiority Trials
2022, Principles and Practice of Clinical Trials