34th WHO Regulatory Update on COVID-19

Overview

The COVID-19 pandemic has revealed the importance of 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.  More than 50% of clinical trials are generally unreported by academics, researchers and industry, often because the results are negative.  These unreported trial results have potential to hinder the design of best-suited trials, cause unnecessary testing and delay the development of innovative safe and efficacious treatments and vaccines.  ICMRA and WHO call on the pharmaceutical industry to commit, within short timelines, and without waiting for legal changes, to provide voluntary access to trial results data for the benefit of public health, while personal data and individual patient data should be redacted.