Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a bi-weekly round-up of some of the key stories. Stories in our final round-up of the year are as follows:
The clinical trial transparency in oncology significantly increased over the recent years– PubMed.gov
Researchers looked at all phase II and phase III oncology clinical trials published in five major journals from 2013-2017. They found that registration and disclosure of oncology trials have significantly increased over the years.
View the article by authors Yeon Song and Young Kim
Access to clinical study reports: EMA’s transparency policy and disclosure of vital documents should not be scaled back (December 2019) – Prescrire in English
Prescrire—along with 30 other organizations—wrote a joint letter to the EMA, urging the agency to improve transparency and accessibility policies. “Full transparency—not secrecy—is the way forward,” the letter says.
Read the open letter here
WHO issues guidance on complying with data integrity regulations – FDA News
WHO recently drafted new guidance and offered recommendations on complying with data integrity regulations. The draft guidance also covers GMP documentation and recordkeeping.
Get the latest news via FDA News