Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure will be bringing a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows:
Senator introduces legislation to amends Sunshine Act – Policy & Medicine
Senator Claire McCaskill proposed the Patient Advocacy Transparency Act of 2018 this week that widens Open Payment reporting and amends the Physician Payment Sunshine Act. The expansions include fundraising events and conferences, while broadening the definitions of grants and covered recipients. The inclusion of non-profit supporters may have complications according to policymed.com, which says “forcing the disclosure of nonprofit supporters was ruled unconstitutional” in the past. The proposed amendments, if accepted, would go into effect in 2023.
Read the full story here.
Release of CRLs and CSRs by the FDA? – RAPS.org
An argument for not keeping clinical study reports (CSRs) and complete response letters (CRLs) confidential was published by Matthew Herder of Dalhousie University in JAMA Internal Medicine. Zachary Brennan reported that while Herder said that the ideal situation is to publish the full reports, FDA Commissioner Scott Gottlieb said they intended to publish subsets of the documents.
Read the full story here.
Opioid product data to be disclosed – The Pink Sheet
Secrecy around the DEA’s opioid distribution data has been challenged according to an analysis by The Pink Sheet’s Brenda Sandburg. Sandburg reports that drug manufacturers have lost in their attempts to limit data disclosure on all opioid products that have been listed as Schedule II drugs.
Read the full story here.
