FDA Trails Behind EMA, Health Canada on Proactive Data Transparency
The FDA needs to be more proactive about sharing clinical trial results with the public, says a new study that compares the European Medicines Agency’s (EMA) and Health Canada’s (HC) data transparency measures with the FDA’s.
In the past decade, the EMA and HC have significantly improved their efforts to share regulatory data with the public, according to a study by eight researchers at Harvard Medical School. “EMA and HC’s routine publication of clinical reports, including clinical overviews and summaries, clinical study reports, protocols, sample case report forms and statistical analysis plans, which just a decade ago had largely been treated by regulators as confidential commercial information, represents a paradigm shift in clinical trial transparency,” the researchers said in a study published by Cambridge University Press.
But the FDA is trailing behind, they said, proactively disclosing data for just a single drug approved in 2018. The EMA, on the other hand, published the data for 123 unique medical products (81 drugs, 38 biologics and 4 vaccines) between 2016 and April 2021 and data supporting 147 regulatory decisions made between 2015 and 2021. HC also shared a large amount of information: data on 73 unique medical products (45 drugs, 23 biologics, 3 vaccines and 2 devices) between 2019 and April 2021 and data supporting 62 initial marketing authorizations and 13 postauthorization applications.
Although the most prolific publisher of trial data, the EMA took the longest to do so — a median of 511 days — while HC took a median 150 days. The FDA’s single report took only 33 days, according to the study.
And when researchers requested comprehensive regulatory data on two drugs — Sovaldi and Harvoni — to test how long the agencies take to fulfill specific requests, both the FDA and the EMA took nearly three years to respond. HC responded with information on Harvoni within six months and on Sovaldi in just under a year.
The FDA did not respond to a request for comment on the study’s findings.
Read the full study here: https://bit.ly/2ZJkB4k.