Abstract
The authors have declared that no competing interests exist. The Fonds National de la Recherche of Luxembourg provided funds to support the submission of the paper (FNR/11/AM4/55, http://www.fnr.lu). Information on the funding of the study referred to is provided in Sundar et al., CID 2008 Oct 15;47(8):1000-6. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Highlights
The need for efficiency is acute in drug development, and in Phase 2 clinical trials, when one will select the drug dose/schedule to be tested at a larger scale in the Phase 3 trials
Tuberculosis is in the same league (18 months from treatment start for the initial assessment and another 12 months for final cure), while with ‘‘only’’ 28–63 days of follow-up, malaria is comparatively much better in this sense
The reason for such long follow-up times is that patients who initially respond favourably may relapse later, and such cases cannot yet be predicted by the current tests of cure
Summary
Adaptive trials designs are increasingly used by pharmaceutical companies to improve efficiencies in the R&D process [1]. There are several ways to specify early termination procedures (for futility), allow repeated analyses to be performed on accumulated data, maintain pre-specified a and b error, or stop the trial as soon as the information is sufficient to reach a conclusion [2] These methods can be grouped as: (i) sequential methods (sequential probability ratio test and triangular test [2,3]) and (ii) group sequential designs (Peto [4], Pocock [5], and O’Brien-Fleming [6] methods; a [7,8] and b [9] spending function; etc.). Following the successful completion of this study in India, DNDi used this design again in a Phase 2 trial of anti-leishmania drug combinations in Africa (ClinicalTrials.gov NCT01067443) Using this approach did not result in shortening trial time; the maximum calculated number of patients was to be enrolled as all treatment regimens proved very effective.
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