WHO Calls For Pharma Transparency In Clinical Trial Data Reporting Medicines & Vaccines 07/05/2021 • Elaine Ruth Fletcher Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) A doctor administering the Johnson & Johnson COVID-19 vaccine candidate during the phase 3 clinical trials. In a far-reaching statement, WHO and the International Coalition of Medicines Regulatory Authorities (ICMRA) called on the pharma industry to provide much wider access to clinical data for all new medicines and vaccines approved, or under review, and even those that had been rejected. “Clinical trial reports should be published without redaction of confidential information for reasons of overriding public health interest,” WHO said in the joint statement on Friday. “The COVID-19 pandemic has brought into sharp focus the need for information and data to support academics, researchers and industry in developing vaccines and therapeutics; to support regulators and health authorities in their decision-making; to support healthcare professionals in their treatment decisions; and to support public confidence in the vaccines and therapeutics being deployed.” WHO noted that while some initiatives to share data with regulators, and store it transparently have met with stakeholder support, such as the WHO International Clinical Trials Registry Platform, the US ClinicalTrials.gov database, and the EMA Clinical Trials Register, “not all past efforts have been successful,” WHO said, adding, “often this was because they were unsustainable due to reliance on goodwill or lack of appropriate resourcing. “Regulators continue to spend considerable resources negotiating transparency with sponsors. Both positive and negative clinically relevant data should be made available, while only personal data and individual patient data should be redacted,” said WHO, adding that, “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 reassurance on the safety or efficacy of the medicine.” Wide and open access to clinical data for new medicines and vaccines will help build trust and the expand access @WHO @US_FDA @EMA_News @CDSCO_INDIA_INF @MoHFW_INDIA @ICMRDELHI @JeremyFarrar @Chikwe_I @jarottingen @pahowho https://t.co/1OACILbdh6 — Soumya Swaminathan (@doctorsoumya) May 7, 2021 “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.” Image Credits: University of Oxford, Johnson & Johnson. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.