Joint Statement on Data Transparency and Integrity International Coalition of Medicines Regulators (ICMRA) and WHO

ICMRA¹ and the WHO call on the pharmaceutical industry to provide broad access to clinical data for all new drugs and vaccines (whether full or conditional, approved in an emergency or rejected). Clinical trial reports should be published without editing confidential data for reasons of overriding public health interests.

The COVID-19 pandemic has sharply focused the need for information and data to support academics, researchers, and industry in vaccine development and therapy; support regulators and health authorities in their decision-making; support healthcare professionals in making treatment decisions; and support public confidence in the vaccines and therapeutics used.

Although some initiatives have found stakeholder support (e.g., the WHO International Clinical Trials Registry Platform, the NIH ClinicalTrials.gov database, the Health Canada Clinical Information Portal, the EMA Clinical Trials Registry, and the Japan Clinical Trials Registry), not all efforts to date have been successful. This was often because they were unsustainable due to reliance on goodwill or lack of adequate resources.²

The common goal of these initiatives is to ensure that research results are available to all those involved in health decision-making. New innovative drugs and vaccines should be a priority. This improves transparency and strengthens the validity and value of the scientific evidence base. To succeed, initiatives need the involvement of multiple stakeholders focused on finding solutions that bring benefits to public health.

Regulators continue to spend significant funds negotiating transparency with sponsors. Both positive and negative clinically relevant data should be made available, while only personal and individual patient data should be changed. In any case, aggregated data is unlikely to lead to the re-identification of personal data and anonymization techniques can be used.

The first benefit is public trust. Regulators open their decisions to public scrutiny by showing confidence in their work.

Another advantage is the possible data integrity check, scientific need and ethical commitment. The data must be robust, comprehensive and verifiable, through review. Data integrity is invaluable. Wrong regulatory decisions made on selected or unreliable data will affect patients receiving this drug.

The lack of public access to negative trials has been identified as a source of bias, which weakens the conclusions of systematic reviews and provides a false sense of security regarding the safety or efficacy of the drug.

Publishing data allows science to progress faster, avoiding the recurrence of unnecessary trials and waste of resources (human and financial). It also benefits by improving the effectiveness of development programs and reducing both development costs and time. Data disclosure also allows for secondary analyzes (and meta-analyzes) that have a different or complementary focus.

Many public bodies have requested open access because the data is a public good. Providing access to data is also due to study participants who have physically contributed and assumed potential research risks.

Not all data is of high quality, and enhanced public oversight should ultimately improve overall data quality. However, resources are needed to share data and systems need to be put in place for such an approach. Data standardization will allow for better analyzes, but it is not a requirement.

Although there is a small risk of data misuse (piracy or data mining for unfair commercial purposes) and misinterpretation, pilot data can be put in context when published with a regulatory review of such data.

The data must be published at the time of finalization of the regulatory review. It cannot be justified to keep confidential data on the efficacy and safety of a medicinal product available on the market or denied market access. Some regulators regularly publish data that supports positive approvals, but fewer do so due to rejection, while this should avoid false expectations, abuse (accidental or not) and security issues. Many completed trials on publishing platforms reveal only protocols, while results remain partial, outdated, or unpublished.

ICMRA and WHO are aware of the concerns that some stakeholders might have when the regulator moves to a higher level of transparency, but we remain convinced of the enormous positive benefits of public health from this.

Providing systematic public access to data supporting the approval and rejection of medicines reviewed by regulators has long been needed despite existing initiatives, such as those of the European Medicines Agency and Health Canada. The COVID-19 pandemic has revealed how important access to public confidence in data is. ICMRA and the WHO call on the pharmaceutical industry to commit, in a short period of time and without waiting for legal changes, to provide voluntary unrestricted access to data on test results in favor of public health.

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¹ ICMRA is a voluntary coalition of drug regulators that provides strategic guidance for enhanced collaboration, improved communication, and effective global crisis response mechanisms.

² Eg. Previous declarations and private initiatives abandoned or unaccompanied include: – Walsh F (February 26, 2013), “Roche promises greater access to trial data” – Alltrials Campaign, https://www.alltrials.net/ (latest data) of March 2019) – Joint Statement of the WHO and the Multiparty Party on the Public Disclosure of Clinical Trials Results, 18 May 2017 (accessed here, March 2021).