“Hidden Trials” In The Age Of Transparency: ClinicalTrials.gov Director Sees Room For Improvement
This article was originally published in RPM Report
Executive Summary
The global push towards clinical trial registration and transparency hasn’t ended the problem of “hidden trials,” the head of NIH’s ClinicalTrials.gov cautions. But the existence of registries helps better analyze the problem and offers some fairly simple steps to get closer to the goal of assuring that all clinical trials are available to the public.
You may also be interested in...
ClinicalTrials.gov Compliance: Absent Regs, Enforcement Of Reporting Still Lags
The National Institutes of Health is still drafting regulations, but Rep. Markey’s TEST Act, which would impose more extensive reporting requirements, has won praise from stakeholders for some of its definitional details. In an election season, its prospects for passing are slim, but aspects of the legislation could serve as a model for pending regulations.
US FDA Alzheimer Guidance Update Reflects Changes In Biomarkers – And Leadership
Latest update to draft guidance on early Alzheimer’s drug development is the third iteration of a document first published in 2013. The history of the guidance is a reflection of structural and leadership changes in the neurology review team at FDA.
Biden’s Co-Pay Cap Is Silver Lining For Pharma In Drug Pricing Campaign
President Biden’s call to expand the US Medicare price negotiation program is naturally making headlines from his campaign-year State of the Union Address. But his call for a national cap on co-pays could be an important opportunity for industry in the years to come.