In a report released today that examines 86 clinical trials of 20 Covid vaccines currently in development or on the market, Transparency International highlighted an “unsettling trend of poor transparency”.
The leading global anti-corruption group warned that without “legally mandated, harmonised, transparent processes and timelines for sharing clinical trial results, pharmaceutical developers can present their data in the most flattering and beneficial light or choose to withhold the data altogether”.
The image below, taken from the report, summarises the key findings.
WHERE ARE THE PROTOCOLS AND RESULTS?
The group noted the detailed protocols of many trials had not been made available, and the results of many trials had exclusively been published via press releases and the media.
According to the report, which reflects the status quo as of March 2021:
“We found that Sinovac Biotech and the Vector Institute published no clinical trial data analysis for their vaccines at all, for reasons unknown, despite both vaccines having been administered to populations since July 2020 and October 2020, respectively.”
COMPARING TRANSPARENCY RULES ACROSS COUNTRIES
The report also includes an overview of transparency requirements in nine jurisdictions.
Specifically, it assessed whether the summary results of trials must be made public on trial registries within 12 months, whether full Clinical Study Reports are made available, and whether the publication of trial protocols is required. “The sharing of clinical trial protocols is important, as it enables external expert scrutiny of methodology and design integrity to highlight potential bias,” the report argues.
The European Union scored highest, meeting all three transparency benchmarks, followed by the United States. India and Russia have none of the three transparency safeguards in place.
Note by TranspariMED: While the European Union and the United States do require summary results for some types of trials to be made public, these rules do not cover all trials, and are currently still not being effectively enforced in either jurisdiction. The report acknowledges this.
CALL FOR STRONGER TRANSPARENCY LAWS
Transparency International's report provides numerous recommendations, including:
Trial registration and summary results: “National governments should adopt, fully implement and enforce broadened legislation which requires all clinical trials to be pre-registered, and make summary results public within 12 months of their completion on a trial registry.”
Trial protocols: “All governments should revise clinical trial legislation to require the public sharing of clinical trial protocols when the trial is approved, on a publicly accessible platform which meets WHO standards, then updated with any amendments at the time of results sharing.”
Clinical Study Reports: “Drug regulatory agencies should make complete clinical study reports available, after excluding individual participant identifiers if unavoidable, within 60 days of approval for all medical products, including COVID-19 vaccines.”
The full report, which also covers transparency in Covid vaccine contracts and pricing, can be accessed on the website of Transparency International’s Global Health programme. A 2017 backgrounder on clinical trial transparency for policy makers by the group can be found here.