Advances in clinical trial design for development of new TB treatments-translating international tuberculosis treatment guidelines into national strategic plans: Experiences from Belarus, South Africa, and Vietnam

Abstract

• The World Health Organization (WHO) plays an important role in setting global norms and standards with a focus on public health and publishes international guidelines regularly to support Member States, particularly ministries of health, in the provision of the highest standard of healthcare. • Over the last 5 years, multiple advances in diagnosis and treatment of tuberculosis (TB) have resulted in a number of new WHO guidelines for TB care, but these recent guidelines have not always been implemented in a timely fashion, raising issues in their adoption and scale-up at country level. • We discuss the experiences of three countries with a high burden of multidrug-resistant TB (MDR-TB)-Belarus, South Africa, and Vietnam-in implementing recent WHO guidelines on bedaquiline, a drug recently registered and recommended for the treatment of MDR-TB and the standardised shorter treatment regimen (STR) for MDR-TB. • The process of adopting and implementing new guidelines requires national TB programmes (NTPs) to interact with multiple agencies: both intergovernmental departments and external agencies such as regulators and donors. These processes are country specific, but there are some generalised challenges that NTPs in high-burden countries experienced when implementing recent WHO MDR-TB guidance. • With multiple trials of new regimens for MDR-TB and new classes of drugs in the clinical treatment pipeline, the frequency of new guidelines for TB is expected to increase, and it is important to support NTPs to implement and scale-up these new developments in treatment.