Challenges and Lessons Learned from PRACTECAL Clinical Trial Implementation

In general, the implementation of a clinical trial such as PRACTECAL includes many challenges. Ethical dilemmas – which were not anticipated before, during and after the trial – create the most learning opportunities for MSF, but also for other organizations as trialists. 

Overall, OCA HQ and the field showed an incredible level of adaptation, creativity, and flexibility to adapt to a new way of working. 

Despite all the challenges and shortcomings related to PRACTECAL implementation, the project ultimately achieved its first objective of identifying a significantly shorter, more effective, and more tolerable treatment regimen for patients fighting MDR-TB. The new regimen has been endorsed by WHO and is currently being rolled out in various countries with a high TB burden, thus pointing to positive progress towards achieving the 2nd project objective as well. This positive result is known by all project stakeholders - within and beyond MSF - and is widely appreciated, including by this evaluation team.