The International Coalition of Medicines Regulators (ICMRA), a voluntary coalition of regulatory leaders that provides strategic guidance for improved collaboration, communication and effective global rapid response mechanisms, and the World Health Organization (WHO) have published a call for the medicines industry to Enable broad access to clinical data for all new drugs and vaccines (whether fully or conditionally approved, used in an emergency or rejected).
“Reports on clinical trials should be published without editing confidential information, as public health interests prevail,” a May 7 statement said.
The COVID-19 pandemic has brought the need for information and data to the fore to help scientists, researchers and industry develop vaccines and therapeutics. Support regulatory and health authorities in their decisions; Assist health professionals in their treatment decisions; and to increase public confidence in the vaccines and therapeutics used, the groups noted.
Regulators continue to devote significant resources to negotiating transparency with sponsors. Both positive and negative clinically relevant data should be provided, while only personal data and individual patient data should be edited.
“Another benefit is the ability to verify data integrity – a scientific necessity and an ethical must,” the organizations say. “Data must be robust, complete and verifiable through peer review.”
“The lack of public access to negative studies has been identified as a source of bias, which weakens the conclusions of systematic reviews and creates a false sense of security about the drug’s safety or effectiveness,” the groups added.
On the other hand, “publishing data enables science to move forward faster by avoiding the repetition of unnecessary experimentation and the waste of resources (human and financial). It also has benefits by improving the efficiency of development programs and reducing both development costs and time, ”the statement said.
Edited by Michael Causey