Confidential Information Clinical Trials

News & Analysis as of

What To Do About Junk Science That’s Published?

We’ve been corresponding recently with long-time friend-of-the blog, Dr. Frank Woodside over the unfortunate fact that junk science these days doesn’t only mean stuff (in the Jeb! sense) that isn’t published in what passes...more

HHS Releases Notice of Proposed Rulemaking Updating Rules for Human Subjects Research

On September 2, 2015, HHS issued the long-awaited Notice of Proposed Rulemaking (NPRM) on revisions to the rules governing federally-funded research involving individuals, commonly referred to as the Common Rule (Subpart A of...more

Clinical Trial Data: The New Regime

The European Medicines Agency moves to increase EU clinical trial transparency. The last five years have seen a sea change in the attitude of EU authorities regarding the disclosure of clinical trial results, moving from...more

European Clinical Trial Regulations Public Consultation – Confidentiality Concerns

Clinical Trial Regulations - On 21 January 2015, the European Medicines Agency (EMA) began a public consultation on the new European Clinical Trial Regulations (CTRs)....more

Recent Insider Trading Case Sparks Concerns Over Leaked Clinical Trial Results

What you need to know: The Martoma insider trading case is the latest in, and largest of, a string of actions brought by the Securities and Exchange Commission related to the alleged misuse of confidential clinical trial...more

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