Adaptive trials for tuberculosis: early reflections on theory and practice

Journal article

Setting: Adaptive designs (ADs) have been proposed for tuberculosis (TB) treatment trials. This call for innovation occurs against the backdrop of fundamental changes in the acceptable evidence base in TB treatment. Objective: To contextualize ADs for TB and explore early responses from those working in the field. Design: A qualitative study investigating processes of theoretical and practical change in randomized controlled trials. As part of this study, twenty-four interviews were conducted with professionals involved in AD trials, half of whom worked in the TB field. Results: Clinical trialists working on AD trials in TB are positive about the efficiencies these designs offer, but remain cautious about their suitability. In addition to technical concerns, informants discussed the challenges of implementing AD in developing countries, including limited regulatory capacity to evaluate proposals; investments needed in infrastructure and site capacity; and challenges of informed consent. Respondents identified funding, interdisciplinary communication and regulatory and policy responses as additional concerns potentially affecting the success of AD for TB. Conclusion: Empirical research is needed into patient experiences of AD, including informed consent. Further consideration is needed of the contexts of innovation in trial design. These are fundamental to the successful translation of theory into practice.

Authors: Montgomery, C

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: International Union Against Tuberculosis and Lung Disease
• Journal: International Journal of Tuberculosis and Lung Disease
• Volume: 20
• Issue: 8
• Pages: 1091-1098
• Publication date: 2016-01-01
• Acceptance date: 2016-04-28
• DOI: 10.5588/ijtld.16.0166
• EISSN: 1815-7920
• ISSN: 1027-3719
• Keywords: context; tuberculosis; adaptive design; clinical trials; statistics