Commits to open sharing of information on clinical trials, including costs
Geneva, 17 November 2022 – Today, Médecins Sans Frontières/Doctors Without Borders (MSF) publicly announced its first Clinical Trial Transparency Policy (CTTP) at MSF’s roundtable discussion, How can disclosing clinical trial costs increase access to medical products? The CTTP outlines MSF’s commitment to the open sharing of information and costs on clinical trials.
“MSF’s Clinical Trial Transparency Policy demonstrates MSF’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. 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, and in turn, would support innovation, price negotiation, and access to lifesaving medical products for all people who need them.”
The MSF CTTP 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 (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.
Many pharmaceutical corporations repeatedly justify their high prices for medicines, vaccines, and diagnostics through claims that huge amounts of money go into the R&D of these medical products. Clinical trials are a major contributor to total R&D costs, but there is currently very little information available on their true costs. Estimates for full R&D costs for the development of new drugs range from US$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.
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.
- 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, this 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.
The commitment to publishing clinical trial costs, as outlined within the MSF CTTP, is a landmark step forward, particularly given the scarcity of available information about the true costs of clinical trials. MSF now will 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, Medical Director, MSF and chief investigator, MSF TB PRACTECAL. “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 so as to maximise 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 recognise 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 in the clinical trials ecosystem and in ensuring access to medical products for all people who need them.
In MSF’s CTTP, a “clinical trial” means any prospective and interventional study in human volunteers with the purpose of knowledge generation. In a clinical trial, volunteers receive interventions according to a predefined research protocol. A “sponsor” refers to an individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial.