The World Health Organization’s (WHO) Global Tuberculosis Programme (GTB) develops evidence-informed policy on all aspects of tuberculosis (TB) prevention and care as new evidence becomes available. As many of the new policy recommendations on treatment and prevention are based on randomised controlled trials, important practical questions related to practical and programmatic implementation remain. These include questions on how to optimize TB medicine dosing strategies and drug delivery approaches among children and adults. Several studies have been conducted or are ongoing to provide answers to these.
There is a growing body of scientific evidence showing that higher doses of some first-line TB medicines may be needed in (specific subgroups of) children to reach target exposures that match exposures in adults receiving the currently recommended WHO doses, to reduce the risk for unfavourable treatment outcomes.
WHO GTB is commissioning a review of available pharmacokinetic (PK) evidence and pharmacometrics models to inform updated dosing guidance of first-line medicines. To this end, WHO is seeking an expert or expert group to develop and test pharmacometrics models to characterize the pharmacokinetics of rifampicin, isoniazid, pyrazinamide and ethambutol (taking into account various parameters such as age, comorbidities, body weight etc) and propose dosing strategies that are aligned (as much as possible) with the proposed harmonized weight bands to be used across WHO programmes. The findings will be reviewed by the Technical Advisory Group (TAG) on dosing of TB medicines in adults and children to inform updated dosing guidance for drug-susceptible TB.
The service provider should be able to work independently as well as to interact regularly and collaboratively with staff from the WHO GTB and other technical experts, as required. For more details on the work and requirements, please review the concept note and the terms of reference.
Proposals will be evaluated based on the following criteria:
- The expert(s) should have extensive experience in clinical pharmacology, pharmacokinetic and -dynamic (PK/PD) analysis and pharmacometric modelling to determine optimized TB drug dosing.
- Evidence should be provided demonstrating a thorough understanding of paediatric and adult TB related clinical pharmacology (for example through published papers in peer-reviewed journals and/or relevant project reports).
- The expert(s) should have excellent writing skills (in English).
- The proposal should include the following:
- Concise and relevant background information
- Primary and secondary objectives aligned with the terms of reference
- A description of the proposed methodology
- List of deliverables
- A proposed timeline
- A short bio of the expert(s) involved
- A detailed budget
Interested experts or groups of experts should respond to this request for proposals by sending their proposal to the Secretariat at verkuijls@who.int. The deadline for receiving proposals is 30 June 2024 (11:59 PM CEST).