PA-539 Developing hands-on skills on tuberculosis sponsor responsibilities and clinical trial management for END-TB in Sub-Saharan

BackgroundThe END TB strategy recommends scaling up of research training and capacity by growing the workforce of scientists in tuberculosis (TB) endemic settings skilled in “development and rapid uptake of new TB tools and “interventions” and “research to optimise implementation and impact”. The SimpliciTB consortium aimed to develop the skills, confidence and international competitiveness of African research leaders engaging in TB while extending network of African sites capable of performing high quality clinical trials in TB. MethodsThrough co-leadership and partnership with St Andrews University, University College London from United Kingdom; Radboud University Medical Center-The Netherlands and TB Alliance-United States mentorship was provided to the senior clinical research fellow and clinical research & development fellow based at Kibong’oto Infectious Diseases Hospital in Tanzania to execute sponsor and trial management responsibilities for a new clinical trial of anti-TB therapy to be delivered in four African countries: Gabon, Malawi, Mozambique and Tanzania. ResultsFrom January 2022- April 2023, achievement in capacity development include design of the potential regimen for a phase III TB clinical trial, and development of the protocol titled: “A pragmatic trial with optimized dose of rifampicin and moxifloxacin for the treatment of drug susceptible pulmonary tuberculosis (OptiRiMoxTB)”. The Operational team meeting was successfully formulated comprising of two categories i) sponsor category with international principal investigators as co-chairs, trial manager and associated core groups including biostatistics and data management, pharmacy and drug management, microbiology and biomarkers, finance and administration and ii) Trial sites each bringing at least the site PI, and site coordinators. Trial-governance including the data safety monitoring and steering committees are set. All sites have submitted ethical and regulatory clearance to their respective bodies and authorities. ConclusionDespite challenges, the preparatory phase has completed and enrolment of participants expects to start in the second quarter of 2023.