Health Desk-9 May 2021: ICMRA1 and WHO call on the pharmaceutical industry to have extensive access to the clinical data of all new drugs and vaccines .Out of considerations that go beyond public health interests, clinical trial reports should not modify confidential information at the time of publication.
The COVID-19 pandemic has attracted intense attention to information and data needs to support scholars, researchers, and industry in developing vaccines and therapeutics; support regulatory agencies and health authorities’ decision-making; support healthcare professionals’ treatment decisions; And to increase public confidence in the vaccines and therapeutics being deployed. The first benefit is public trust. Regulators are opening up their decisions to public review, which shows that they are confident in their work.
Another advantage is checking data integrity, scientific necessity and moral necessity. Through peer review, the data must be robust, detailed and verifiable. Data integrity is priceless. Wrong regulatory decisions based on selected or unreliable data will affect patients receiving the drug. ICMRA and WHO recognize that as regulators increase transparency, certain stakeholders may be concerned, but we remain confident in the overwhelming public health benefits of doing so. Despite existing initiatives such as the European Medicines Agency and Health Canada, the practice of providing the public with systematic public access data to support drugs reviewed and approved by regulatory agencies should be overdue long ago. The COVID-19 pandemic has revealed the importance of public trust in data access. ICMRA and WHO call on the pharmaceutical industry to commit to providing public health with unrestricted voluntary access to trial result data within a short period of time and without waiting for legal changes.