Home Clinical Trial Data Disclosure Yale Leads Study Group to Develop New Assessment Tool for Greater Industry...

Yale Leads Study Group to Develop New Assessment Tool for Greater Industry Sponsor Clinical Trial Disclosure & Transparency

119
0
医学 (Medicine)

Researchers from Yale, Stanford, and Bioethics International conducted a study to show a path to promote greater sharing of clinical trial data by pharmaceutical companies. The researchers assessed industry sponsors and found that about 33% met the standards for data sharing while many others could improve transparency through disclosure.

Published in the BMJ, the team found that since the late 1990s, new laws and regulations have increased requirements for industry sponsors to register and report results from clinical trials. Yet some companies don’t fully comply, and industry guidelines vary. The research team developed a new tool to assess the data-sharing practices of large industry sponsors (E.g. biopharmaceutical companies).

The Assessment Tool

The team applied the assessment tool to large industry sponsors with drugs approved by the FDA in 2015. They found that 25% of companies fully met their required standards. These standards include:

  •         Registering clinical trials
  •         Sharing data and study protocols publicly
  •         Reporting requests for data on an annual basis

The tool apparently can help companies improve their overall score and better meet transparency requirements.

Lead Research/Investigator

Jennifer Miller, Assistant Professor, Yale

LEAVE A REPLY

Please enter your comment!
Please enter your name here

This site uses Akismet to reduce spam. Learn how your comment data is processed.