title: Adaptive trials for tuberculosis: early reflections on theory and practice.
abstract: Adaptive designs (ADs) have been proposed for anti-tuberculosis treatment trials. This call for innovation occurs against the backdrop of fundamental changes in the acceptable evidence base in anti-tuberculosis treatment.
  
  
  
  To contextualise ADs for tuberculosis (TB) and explore early responses from those working in the field.
  
  
  
  In this qualitative study investigating processes of theoretical and practical change in randomised controlled trials, 24 interviews were conducted with professionals involved in AD trials, half of whom worked in the TB field.
  
  
  
  Clinical trialists working on AD trials in TB are positive about the efficiency 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 regarding informed consent. Respondents identified funding, interdisciplinary communication and regulatory and policy responses as additional concerns potentially affecting the success of AD for TB.
  
  
  
  Empirical research is needed into patient experiences of AD, including informed consent. Further consideration of the contexts of innovation in trial design is needed. These are fundamental to the successful translation of theory into practice.
authors.affiliation: Amsterdam Institute for Social Science Research, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: C M
authors.initials: CM
authors.lastname: Montgomery
mesh_terms: D000075522:Adaptive Clinical Trials as Topic / Q000191:economics / Q000379:methods* / Q000706:statistics & numerical data; D000995:Antitubercular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003627:Data Interpretation, Statistical; D003906:Developing Countries; D006801:Humans; D007258:Informed Consent; D007407:Interviews as Topic; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000379:methods* / Q000706:statistics & numerical data; D012107:Research Design / Q000706:statistics & numerical data; D012109:Research Support as Topic; D013997:Time Factors; D016896:Treatment Outcome; D014376:Tuberculosis / Q000175:diagnosis / Q000188:drug therapy*
chemical_list: D000995:Antitubercular Agents