International regulators and WHO call for wider public access to clinical data
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) are urging pharmaceutical companies to publish clinical trial reports for new medicines and vaccines without redactions to ensure that research results are publicly accessible to all those involved in healthcare decision-making. In a joint statement, they stress that systematic transparency can increase trust in regulatory decision-making, reassure the public about data integrity and can stimulate research and development, which could have a positive impact on vaccine confidence.
“The COVID-19 pandemic has brought into sharp focus the need for improved transparency of medical research,” said Emer Cooke, Chair of ICMRA and EMA’s Executive Director. “As our policy of proactive publication of clinical data demonstrates, EMA has long been committed to making the data on which our regulatory decision-making is based available for public scrutiny. I’m very pleased that ICMRA and WHO have come together on this and are supporting our own efforts and similar approaches. This could be the beginning of a new era of much wider access to trial results data for the benefit of public health.”
The development of the joint statement followed a series of discussions among ICMRA members and WHO on new ways to enhance transparency and data integrity. The ICMRA-WHO statement is available on the ICMRA and WHO websites.