Call for transparency: Detailed cost analysis of MSF’s TB-PRACTECAL clinical trial in PLOS Global Public Health

The phase 2b-3 multi-arm multi-stage trial was conducted in low-resource health settings in Belarus, South Africa, and Uzbekistan, helped identify a shorter, all-oral treatment for drug-resistant tuberculosis (DR-TB), and cost a total of €33.9 million.

The article, “Cost analysis of the TB-PRACTECAL clinical trial on novel tuberculosis treatment regimens,” marks the first time that the detailed costs of an individual clinical trial have been publicly shared, challenging the lack of transparency around drug research and development (R&D).

Building on this analysis, MSF also developed a clinical trial cost reporting toolkit to encourage other stakeholders to publish their clinical trial costs.

Dr Bern-Thomas Nyang'wa, medical director for MSF Netherlands:

“By disclosing our clinical trial costs for drug-resistant TB treatment, we’re issuing a call to action for all other actors involved in drug development to make their clinical trial costs public. In showing by doing, we aim to demonstrate that transparency in R&D spending can and must be done; it is critical to determine fair prices of medical products, equitable access, and public accountability.

“Time and time again, we have seen the high prices of medical products justified based on the high costs of R&D – but these costs are kept secret by the pharmaceutical industry, leaving pricing decisions lacking in evidence. In the case of the TB drug bedaquiline, access was delayed for over a decade due to its exorbitant price. It was the public disclosure of the significant public and non-profit investments in its development that supported a global movement leading to a price reduction of this lifesaving drug.

“We urge all funders and implementers of clinical trials — and R&D more broadly — to publicly disclose their costs, which are essential for governments, policymakers, researchers, activists, and affected communities to determine affordable prices and ensure equitable access. The call for transparency is even more urgent when it comes to diseases like TB, in the area of antimicrobial resistance, and for pathogens of pandemic potential — where there is a critical need for new and affordable vaccines, treatments, and diagnostics.”