MSF releases clinical trial transparency policy to promote equity in biomedical R&D ecosystem
In a bid to bring transparency in clinical trial costs which will in turn increase equity in the biomedical R&D ecosystem, Médecins Sans Frontières (MSF), a global medical non-governmental organization, has approved and published its first Clinical Trial Transparency Policy (CTTP). This policy is a commitment to publishing research protocols, registering clinical trials on appropriate registries, and subsequently publishing clinical trial data in open access formats, in line with the World Health Organization (WHO) joint statement on public disclosure of results from clinical trials, to which MSF is a signatory.
This policy applies to all anonymized clinical trial data, protocols and clinical study reports, where MSF is a sponsor and controls the generated data. In trials where MSF is a collaborator but not a sponsor or has no control over the data, it will make all efforts to ensure that partners adhere to the policy which came into force from October 18 2022.
This policy also includes commitments to publishing a minimum set of cost items for clinical trial costs. The cost items suggested for reporting draw on published reporting guidance. This policy is a first step for MSF as it has not yet published any clinical trial costs associated with the trials it is involved with. The medical nongovernmental organization will now begin the process of implementing this policy.
This is a landmark commitment by MSF. The Drugs for Neglected Diseases initiative (DNDi) is currently the only actor that has published some of their out-of-pocket research and development (R&D) costs per phase of development.
This demonstrates MSF’s commitment to, and recognition of, why and how clinical trial costs should be made public, and that this is a critically important step towards increasing access to medical products for all who need them.
Shedding light on the reason behind the release of its Clinical Trial Transparency Policy, MSF said “We operate under the five working principles of impartiality, independence, neutrality, bearing witness, and transparency. We consider transparency as critical for ensuring accountability towards our patients and their communities, and an important tool to improve public health by enabling evaluations of our practices and positioning on medical humanitarian issues. The principle of transparency is especially important in the field of medical research, where the information asymmetry among patients, researchers, and the public can result in mistrust and impede progress. Clinical trial costs are the largest contributor to total R&D costs, and poor reporting practices hinder the creation of reliable cost estimates and proportionate funds for R&D. By reporting clinical trials costs, we support ourselves and other entities to generate reliable predictions for future R&D ventures and make proportionate and rational investments – especially for research in low-resource settings. Transparency of clinical trial costs could therefore support innovation and involvement in clinical trials especially from non-traditional actors. This in turn increases equity in the biomedical R&D ecosystem.”
All clinical trials which fall within the scope of this policy should be registered with an internationally recognized clinical trial registry (e.g., ClinicalTrials.gov or another register listed as primary registries on the WHO International Clinical Trials Registry Network). Any changes to information registered on a clinical trial registry (e.g., number of patients enrolled, recruitment status, outcome measures) should be updated on the trial entry in a timely fashion.
The timely and open publication of clinical trial results is an ethical imperative in research and also important to minimize a duplication of effort and to build trust with past and future trial participants, stated the global medical NGO.
“Key results of clinical trials falling under this policy should be reported within 12 months from the completion of the clinical trial in question in an internationally recognized clinical trial registry (e.g.,ClinicalTrials.gov or another register listed as primary registries on the WHO International Clinical Trials Registry Network). Full clinical trial data should be published in their entirety in open-access peer reviewed journals, ideally within 24 months of the completion of the clinical trial. Alternatively, if efforts to publish in a peer reviewed journal are unsuccessful, results and data should be published on a publicly accessible free server,” it added.
Source : 1