Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows:
FDA discusses efforts to assure transparency at foreign drug manufacturing facilities – FDA
In a statement on the FDA website, Commissioner Scott Gottlieb, M.D. announced an internal policy titled Understanding CDER’s Risk-Based Site Selection Model to bring greater transparency to their site selection model. The policy details “how a facility’s compliance history, recall trends, time since last inspection, inherent risk of the drug being manufactured, processing complexity and other factors are all weighed and considered.”
Read the full announcement here.
EudraCT public web report published – European Medicines Agency (EMA)
EMA published its monthly web report on statistics from the EudraCT Database. In August 2018, 54,812 clinical trials were disclosed in the EudraCT Database. Of the clinical trials recorded, 79 percent were commercial and 21 percent were noncommercial.
Read the full report here.
Financial disclosures lacking in new report – JAMA Oncology
A research letter, published in JAMA Oncology, noted concerns over financial conflict-of-interest in the reporting on clinical trials for oncology drugs. It was found that 32 percent of oncologist authors did not fully disclose payments from the trial sponsor.
Read the full letter here.
Global transparency event in London – DIA
On September 19-20, 2018, the Drug Information Association (DIA) will host its annual Global Clinical Trials Transparency Conference in London. Invited speakers will discuss developments in relation to implementation of EMA’s Clinical Data Publication Policy 0070, NIH Final Rule for FDAAA, ICMJE Data Sharing Requirement, EU GDPR, EU Medical Device Regulation, Health Canada’s draft guidance on Public Release of Clinical Information, and FDA’s new initiatives on sharing clinical documents publicly. TrialAssure will be there to bring you all the news.
View the agenda here.
