NEW YORK/GENEVA, April 25, 2024—The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) announced the costs of its landmark TB PRACTECAL clinical trial today—approximately $36 million—marking the first time the detailed costs of an individual clinical trial have ever been shared publicly.
The release of this information challenges the lack of transparency around drug development and the prevailing narrative that high prices are needed to recoup high research and development (R&D) costs. Other public and non-profit actors must now follow suit as increasing transparency around R&D costs would help ensure better access to lifesaving medical tools for people who urgently need them.
“We hope that our disclosure of clinical trial costs for identifying an improved regimen for drug-resistant tuberculosis (DR-TB) will serve as a clarion call for other public and non-profit actors to join us and publicly share their clinical trial costs to ensure broader transparency in medical R&D costs,” said Dr Bern-Thomas Nyang’wa, MSF medical director and chief investigator of the TB PRACTECAL trial, which found a shorter, all-oral treatment regimen for DR-TB.
The cost of clinical trials is often the biggest part of the overall cost of R&D of health products, yet their actual costs have remained a mystery, with no disaggregated data on biomedical R&D costs publicly available. The current estimates for full R&D costs for new drug development range from $43.4 million to a staggering $4.2 billion, using varied methodologies. Cost estimates for pharmaceutical phase II and phase III clinical trials range from $5 million to $142 million. The pharmaceutical industry has long claimed that high prices are needed to recoup high R&D prices and sustain future innovation, but research has shown that there is no link between high drug prices and industry spending on R&D.
To encourage more transparency around clinical trial costs, MSF developed “Transparency CORE,” a clinical trial cost reporting toolkit, and urges all public and non-profit actors to publish their clinical trial costs and support the development of international policy to mandate standardized cost reporting. This information would equip governments, policymakers, researchers, activists, and affected communities with the vital information needed to have evidence-based conversations about pricing policies and provide more leverage to negotiate fair prices.
“We encourage clinical trial sponsors and implementors to try our ‘Transparency CORE toolkit’ and to build on it as a guide to facilitate the publication of cost data,” Nyang’wa said. “Transparency in clinical trial costs is a transformative step towards exposing what medical innovation actually costs and building a future where access to medicines and medical tools is not hindered by high prices.”
For more than a decade, the critical TB drug bedaquiline, which is the backbone of all DR-TB regimens including the TB PRACTECAL regimen, remained out of reach for people with DR-TB due to its exorbitant price. The revelation from academic research that the public investment in bedaquiline’s R&D was up to five times more than the private investment was pivotal information in a global movement led by TB activists and civil society that resulted in a significant price reduction for this lifesaving drug.
“The global movement that pushed for a significant price reduction of the lifesaving TB drug bedaquiline demonstrated that transparency of R&D costs can lead to increased access to medical tools and help save more lives,” said Roz Scourse, policy advisor with MSF’s Access Campaign. “The unsubstantiated yet dominant narrative that high prices are needed to recoup high R&D costs can no longer remain an evidence-free zone. This information is a critical piece of the policy puzzle that can inform the price of medical products and who gets access. Today we are challenging this narrative and showing that publishing detailed clinical trial costs can—and must—be done.”
For several years, MSF has been calling on the US government in particular to publicly disclose the costs of clinical trials. As the largest funder of biomedical research in the world, the US government has an opportunity to lift the veil on clinical trial costs and model the kind of transparency and accountability we should see from all funders.
