MSF publishes clinical trial cost, challenges pharma to do the same

New Delhi: Médecins sans frontières (MSF) has published a detailed breakup of the cost of its clinical trial for a new drug regimen for TB drawing attention to zero transparency about clinical trial costs. Roz Scourse, a policy advisor with MSF's Access Campaign, spoke to Rema Nagarajan about the importance of trial cost as it constitutes a significant proportion of high R&D spend claimed by pharma to justify high drug prices, without making public a breakdown of this claimed expense.

What is the significance of MSF making the cost of the TB-PRACTECAL clinical trial public?

There are a lot of interrelated reasons why this is important. Firstly, one of the things MSF has struggled with is high prices of drugs, including of bedaquiline, a crucial TB drug. One of the prevailing narratives is that such high prices are needed to recoup R&D costs. This is not backed by any data. There is no requirement to make the breakdown of clinical trial costs – or R&D costs more broadly - public. If the industry is going to make these claims, they need to be backed with the actual breakdown of costs, because these costs influence drug prices and access. Secondly, transparency on clinical trial costs can contribute to the design of future R&D initiatives and incentives – particularly where there is a lack of commercial interests – such as in TB. These costs also help show non-profits and public funders who may be interested in funding/doing trials how much they really cost and what the key cost drivers are - which helps in budget planning and allocation, especially in LMICs (low and middle-income countries).

Can this trial be compared to trials done as part of R&D for discovering new drugs?

The costs for this trial cannot be compared apples to apples with any other trial since – to our knowledge – this is the first time that the detailed costs of a clinical trial have been published, so other figures that are out there are estimates or averages. There are many different types of trials which are important for different reasons – this was an extremely important trial looking for shorter, less toxic treatment regimens for TB - an area that is not of commercial interest to the industry. So, it wasn’t about the discovery of a new drug – but a safer, shorter, more effective treatment regimen. We don’t have any transparency on the costs of other clinical trials at all and so we have nothing to compare it to.

What is the share of clinical trials in R&D cost of drugs?

We don’t really know exactly, because there is no detailed breakdown on the costs of R&D, but we do know that clinical trials are the most expensive part of the overall R&D process. The detailed breakdown of this will depend on the product/area of research.

How much did the trial cost? By how much is it less than what is estimated by the drug companies for clinical trials?

The trial cost $34 million. Since we don’t have any industry clinical trial costs available, we cannot compare directly. We only have estimates or averages to go by – cost estimates for pharmaceutical phase 2 and phase 3 clinical trials range between $5 million and $142 million. 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. But we cannot rely on estimates and averages. MSF recognises this lack of transparency and so we are publishing the costs of TB-PRACTECAL to show how much it cost us. Astonishingly, this is the first time ever that this has been done in this amount of detail. We are challenging others to start publishing their clinical trial costs – and R&D costs more broadly - because of how important it is to pricing, and access to the end product. We say to industry that if they want to claim that high prices are needed to pay R&D costs, they should just make them public and publish them. Why not do that if they have nothing to hide?

What is the Transparency CORE toolkit you have developed? How will it help?

Recognising the lack of transparency in clinical trial costs, MSF agreed on a clinical trial transparency policy back in 2022, which committed to publishing the costs of clinical trials that MSF is involved in. Building on the learning of publishing the costs of TB-PRACTECAL, we developed a toolkit to facilitate the analysis and publication of future clinical trial costs. The toolkit consists of a standardised financial reporting template – a set of 27 cost items to report – as well as a user manual. The 27 cost categories include things like staff, materials, external services and so on. Ideally, we need funders and actors doing the clinical trials to do it in the same way so that there is a standardised way of reporting clinical trial costs. We want funders to try and use it and adapt it for their institutions. We are saying it is possible to do this and this is how we did it, here are the suggested cost items to report. More broadly, we hope that this toolkit can initiate the development of international standard guidelines or policy on reporting trial costs.

How can pharma companies be persuaded to use the toolkit?

Initially, we are urging public funders and non-profits and actors doing clinical trials to take up the use of this tool. They can use it to report the cost of clinical trials in a detailed, standardised and transparent manner. If there is public money involved, there needs to be transparency and accountability. More broadly, if the industry is going to continue to make claims around how much innovation costs and how much it costs to do R&D, they will have to publish their costs in detail and the claims should be scrutinised. What are they hiding? Why not publish? So, it is also to put pressure on the industry for greater transparency.