The World Health Organization (WHO) has published a position statement entitled Innovative Clinical Position Statement on Innovative Clinical Trial Designs for Development of New TB Treatments. The document is intended to support researchers and drug developers in the development of tuberculosis (TB) treatment regimens by outlining key clinical trial characteristics.
The WHO resource summarizes important innovations in TB clinical trial designs. These innovations include pharmacokinetic-pharmacodynamic (PK-PD) modeling, as well as recent advances in biomarker development, and novel clinical trial design methodologies; and post-licensure observational studies.
“The discovery, development, and rapid uptake of new tools, interventions, and strategies are critical to substantially reduce TB incidence and reach the global End TB targets,” said Tereza Kasaeva, director of the WHO Global Tuberculosis Program. “This includes shorter, safer and more effective regimens for treating drug-sensitive TB and drug-resistant TB that can be used in all patient populations, including children, pregnant women, people living with HIV, and other populations at-risk”.
The position statement targets TB drugs and regimen developers (such as pharmaceutical firms), TB researchers and study teams, preclinical scientists, and modelers. Further, the WHO in the document calls for increased collaboration as well as data sharing and integration and standardization of tools and measurements to advance scientific discovery.
The WHO statement also underscores the importance of engaging with various national TB programs and affected communities. The goal is to help facilitate the translation of evidence into national and global policies on TB treatment and care.
According to the WHO, innovations in TB drug development and trial design are expected to accelerate the development and evaluation. Additionally, optimized trial design is anticipated to help facilitate the approval of novel regimens to treat all forms of TB and lead to a welcome expansion of the TB drug pipeline.
In its most recent TB report (issued October 2020), the WHO reports that the disease was one of the top 10 causes of death around the globe in 2019, killing 1.4m. That year, approximately 10m people received a TB diagnosis: 5.6m men, 3.2m women, and 1.2m children.
Additionally, the 30 countries hit hardest by TB accounted for about 87% of cases. Eight countries alone account for two-thirds of the total: India, Indonesia, China, the Philippines, Pakistan, Nigeria, Bangladesh, and South Africa. Multidrug-resistant TB (MDR-TB) is a significant global health crisis, with 206,030 diagnoses reported.
For more information on the WHO position statement on TB trial design, read the document here.