MSF publishes first clinical trial transparency policy

Open sharing of the costs of clinical trials and information could help expand access to lifesaving medicines, vaccines, and diagnostics.

Hepatitis C Sofosbuvir and Daclatasvir pills in India.

India 2018 © Garvit Nangia/MSF

NEW YORK/GENEVA, NOVEMBER 17, 2022—The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) publicly announced today its first clinical trial transparency policy (CTTP). The CTTP outlines MSF’s commitment to the open sharing of information and costs of clinical trials and hopes to set a new norm for other clinical trial conductors, like pharmaceutical corporations, to disclose this information. This could help drive down prices and expand access to lifesaving medicines, vaccines, and diagnostics.

“MSF’s clinical trial transparency policy demonstrates the organization’s commitment to this issue and will hopefully put a spotlight on why clinical trial transparency is so important and encourage more open sharing of the true costs of medical research and development (R&D) for public health,” said Roz Scourse, policy advisor with MSF’s Access Campaign. “With a lack of transparency hindering much of our work on access to medical products, more publicly available information around clinical trial costs would be one critical step forward.”

Currently, most clinical trial information, including costs, are closely held secrets as many pharmaceutical corporations repeatedly justify their high prices for medicines, vaccines, and diagnostics through claims that a lot of their money goes back into the R&D of medical products. However, while clinical trials are a major contributor to total R&D costs, there is currently very little information available about their true costs. Estimates for full R&D costs for the development of new drugs range from $43.4 million to $4.2 billion, depending on the methodology used. That this range varies a hundredfold demonstrates how important it is to establish the true costs of R&D, including clinical trials.

“Access to information about the true costs of clinical trials would help challenge narratives about the high costs of R&D that are put forward by many pharmaceutical corporations without real evidence,” Scourse said. “This would, in turn, support innovation, price negotiation, and access to lifesaving medical products for all people who need them.”

The CTTP—announced during MSF’s recent roundtable discussion titled How can disclosing clinical trial costs increase access to medical products?—commits to publishing research protocols, registering clinical trials, publishing clinical trial data in open access formats, and publishing a minimum set of costs for MSF clinical trials. This is in line with the World Health Organization’s (WHO) joint statement on public disclosure of clinical trial results, to which MSF is a signatory, as well as published reporting guidance, which provides recommendations to achieve greater transparency of clinical trial costs. 

The commitment to publishing clinical trial costs, as outlined within the MSF’s CTTP, is a landmark step forward, particularly given the scarcity of available information about the true costs of clinical trials. MSF will now aim to publish the costs of current MSF-supported clinical trials as “pilot” studies, which will also help inform the process of publishing information about trial costs for MSF in the future.

“MSF calls for clinical trial cost transparency as one of the tools that can support efforts to increase equity in biomedical R&D systems and, subsequently, access to medicines, and so it is good that we are finally committing to walk the talk,” said Dr. Bern-Thomas Nyang'wa, MSF medical director and chief investigator of MSF’s TB PRACTECAL clinical trial. “We ourselves have some way to go. To start, we hope to publish the costs of the TB PRACTECAL clinical trial, while also developing some best-practice guidelines to inform future publication of MSF clinical trial costs.”

This announcement from MSF comes at a time when there is increasing political momentum and discussions around how clinical trials can be improved to maximize their impact on public health. Central to these efforts is the WHO Clinical Trial Resolution, which was adopted at the World Health Assembly (WHA) this year. The ongoing WHO Pandemic Accord negotiations are also an opportunity to recognize the central importance of clinical trials to any pandemic response. These and other domestic efforts must mandate the public disclosure of clinical trial costs, given the central role access to this information would play in improving equity related to clinical trials and in ensuring access to medical products for all people who need them.

For years, MSF has advocated for the US government to force pharmaceutical corporations to disclose the costs of clinical trials on a government website. Companies are often given taxpayer money to create new health products without any conditions attached.

Greater transparency of clinical trial costs would:
• Expose true costs: Help generate reliable information about how much clinical trials actually cost, which would support sound decision-making around R&D investments, especially in low-resource settings like those in which MSF works.
• Promote innovation: Support and promote the involvement of non-traditional actors in clinical trials, especially in low-resource settings, as a lack of cost transparency can act as a deterrent for some countries and actors to conduct or be involved in clinical trials. This, in turn, would increase equity in the biomedical R&D ecosystem.
• Support price negotiation: More balanced access to information around how much clinical trials cost would increase the ability of governments and treatment providers to challenge industry claims of the need to “recoup” high R&D costs through high prices, and thus aid them in regulating and negotiating prices more effectively.  
• Provide accountability for the use of funding: Where clinical trials are publicly funded, this can support efforts to ensure public return on public investments.