Adaptive trials for tuberculosis: early reflections on theory and practice.

Area of Science:

• Clinical Trials
• Tuberculosis Research
• Biostatistics

Background:

• Adaptive designs (ADs) are proposed for anti-tuberculosis (TB) treatment trials amidst evolving evidence standards.
• Innovation in trial design is needed to address current challenges in TB research.

Purpose of the Study:

• To contextualize ADs for TB clinical trials.
• To explore the perspectives of professionals involved in AD trials within the TB field.

Main Methods:

• Qualitative study design.
• 24 in-depth interviews with professionals involved in AD trials.
• Focus on professionals working in TB and non-TB trial settings.

Main Results:

• Professionals view ADs as efficient but have concerns about suitability for TB.
• Implementation challenges in developing countries include regulatory capacity, infrastructure, and informed consent.
• Key concerns for AD success in TB include funding, interdisciplinary communication, and policy.

Conclusions:

• Further empirical research on patient experiences with ADs, including informed consent, is necessary.
• Understanding the context of innovation in trial design is critical for translating AD theory into practice for TB.
• Addressing regulatory, infrastructural, and communication challenges is vital for successful AD implementation in TB trials.