Transparency CORE: Clinical Trial Cost Reporting Toolkit
Clinical trials are widely recognised as the most expensive component of the research and development (R&D) of a medical product, yet their actual costs have remained undisclosed. Transparency of clinical trial costs is needed to inform pricing policies and innovative ways to fund biomedical R&D – measures that can foster increased access to medical products.
Recognising the importance of transparency of clinical trial costs, Médecins Sans Frontières/Doctors Without Borders (MSF) adopted a Clinical Trial Transparency Policy (CTTP) in 2022, commiting to open sharing of information and costs related to clinical trials led or supported by MSF. To pilot the implementation of the policy, MSF has taken steps to publish the costs of the TB-PRACTECAL clinical trial, a multi-country, randomised controlled trial to report on the efficacy and safety of a six-month, all-oral treatment regimen for people living with tuberculosis (TB).
The process of developing and executing a methodology to identify all the costs related to TB-PRACTECAL also allowed the development of the ‘Transparency CORE’ toolkit to facilitate the analysis and publication of future clinical trial costs. The toolkit consists of:
- a manual, which provides the standard operating procedures for costing a trial and different cost categories used therein; and
- an Excel template for cost reporting and analysis.
We encourage clinical trial sponsors and implementors to try the toolkit and build on it to facilitate the publication of cost data and contribute to greater transparency in R&D of medical products.
