The COVID-19 pandemic has exacerbated the need for data sharing to support researchers, health authorities, healthcare professionals, and the public in the development, regulation, deployment, and understanding of new therapeutics and vaccines. In response to this, the World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) released a joint statement on transparency and data integrity, in which they urge the pharmaceutical industry to provide greater access to clinical data for all new medicines and vaccines, regardless of approval status. The statement, released in May, recommends that both positive and negative clinically relevant data are published in full, with only personal and individual patient data redacted.
The cited benefits of this approach include:
- increased public trust and confidence in regulatory decisions
- opportunity to peer review the data to ensure they are robust, exhaustive, and verifiable
- removing the bias resulting from lack of public access to negative trial data
- faster advancements in research through optimisation of resources
- allowing trial participants to access data that they contributed to.
Implementing this initiative will require consideration of factors such as availability of resources and systems needed for data sharing, and the timing of data release. WHO and ICMRA acknowledge that stakeholders may have concerns over increasing levels of transparency, but state that these are far outweighed by the resulting benefits to public health.
WHO and ICMRA acknowledge that stakeholders may have concerns over increasing levels of transparency, but state that these are far outweighed by the resulting benefits to public health.
The statement notes that while some initiatives to improve data transparency and access have been successful (such as the WHO International Clinical Trials Registry Platform or the US National Institutes of Health ClinicalTrials.gov database), such efforts have not always been followed through, often due to lack of resourcing or reliance on goodwill. We look forward to seeing how this call to action is answered by the pharmaceutical industry.