Friday, February 22, 2008

Clinical Research - a baby in dire need of a change

This morning, Pharmalot features a post indicating yet another state Attorney General has decided to sue pharmaceutical manufacturers. This time, it's Montana vs AZ and Jansen for pushing antipsychotic meds that are, according to state AG Mike McGrath, “in defective condition and unreasonably dangerous”. Between the product liability suits, fights about state vs federal rights and [legitimate] concerns about obfuscation I think anyone with a conscience must agree that it's time for real transparency in data from clinical studies.

The only way to provide any level of confidence in the data from clinical research would be to mandate public access to the raw data (actual complete listings), data management and statistical analysis plans for clinical trials. Manufacturers will, of course, complain that this requirement would make confidential and proprietary information available to competitors and put them at an unfair disadvantage but since everyone would have to comply to the same standards, what would be created is more akin to a level playing field that may actually improve research standards as well as help people better compare and contrast drug safety and efficacy data.

In making this sugestion, I am making no difference between industry sponsored clinical trials, industry supported "investigator sponsored" studies and truly independent clinical research. In other words, medical/scientific article reviewers and readers alike should have access to review the raw data for these publications to ensure nobody is taking liberties with data.

Also, in addition to requiring lead authors to disclose funding and pharma relationship information for themselves, we should require that info be provided by all authors as well as full disclosure of funding/relationship issues for journal editors and article reviewers. Let us all draw our own conclusions to what potential bias (intentional or not) exists.

If I could, I'd also go so far as requiring IRBs to set up more stringent (routine) site/PI/study auditing requirements for "independent" studies that are not subject to source document & protocol adherence verification.

These suggestions will tick off manufacturers and researchers alike, but implementation is an absolute must if we are to regain any confidence in the medications we use.


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Expert Regulatory Affairs Consulting said...

Nice post.

Fda Pharmaceutical said...

Thanks for this great post......