ICMRA1 and WHO have called on the pharmaceutical industry to provide wide access to clinical data for all new medicines and vaccines.
Both positive and negative clinically relevant data should be made available, while only personal data and individual patient data should be redacted.
In any case, aggregated data are unlikely to lead to re-identification of personal data and techniques of anonymization can be used. Data must be robust, exhaustive and verifiable, through peer-review.
Data integrity is priceless. Wrong regulatory decisions, made on selected or unreliable data, will affect the patients who receive that medicine.
Publication of data allows science to advance faster, by avoiding repetition of unnecessary trials and waste of resources (human and financial).
Publication of data also allows secondary analyses (and meta-analysis) which have a different or complementary focus.
Many public bodies have made open access a requirement as data are a common good. Providing access to data is also owed to trial participants who contributed physically and took the potential research risks.
Not all data are of high quality, and increased public scrutiny should eventually improve the overall quality of data. Resources however are needed for data sharing, and systems for such access need to be established.
Standardization of data will allow better analyses but is not a requirement.
While there may be a small risk of misuse of data (piracy or data mining for unfair commercial purpose) and misinterpretation, trial data can be put in context when published with the regulatory review of such data.
It cannot be justified to keep confidential efficacy and safety data of a medicine available on the market, or which has been refused access to the market.
Some regulators regularly publish the data that support positive approvals, but fewer do this for rejections, while this should avoid false expectations, misuse (accidental or not) and safety issues.
Providing systematic public access to data supporting approvals and rejections of medicines reviewed by regulators, is long overdue despite existing initiatives, such as those from the European Medicines Agency and Health Canada.
The COVID-19 pandemic has revealed how essential to public trust access to data is.
ICMRA and WHO call on the pharmaceutical industry to commit, within short timelines, and without waiting for legal changes, to provide voluntary unrestricted access to trial results data for the benefit of public health.
