A World of Processes

August 12, 2013
Lisa Henderson

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and Pharm Exec. She can be reached at lhenderson@mmhgroup.com.

Applied Clinical Trials

JAMA recently announced a change in editorial policy whereby it will no longer have independent academic statisticians review industry-sponsored clinical trial data.

JAMA recently announced a change in editorial policy whereby it will no longer have independent academic statisticians review industry-sponsored clinical trial data. The policy, as explained here, was adopted in 2005 when controversies arose whether pharma sponsors were not forthcoming or purposely manipulating unfavorable data within submitted articles.

JAMA’s Editor in Chief, Howard Bauchner, MD, explained the new stance in an editorial. “Advances over the past decade in standards of clinical trial reporting, enhanced understanding of the threats to validity of clinical research, increasing data transparency, and our experience support the change in policy.” That experience specifically was an analyses conducted by JAMA over the past two years uncovering no “meaningful changes” in study results from their own independent reviews.

In 2010, before Dr. Bauchner was the Editor in Chief, then JAMA Editor in Chief Catherine DeAngelis, MD, reinforced the need for this type of independent statistical review in light of the Avandia scandal. She said at the time: Imposing such a requirement before publication "assures that if there is any question about the veracity of statistical analysis, the editor can call the dean of the institution where the statistician is a faculty member and ask for a review of the statistical analysis."

At that point, the International Committee of Medical Journal Editors (ICMJE) was voting to incorporate pre-publication statistical review to all of its Journal members, of which JAMA was the only one who did that. It was never implemented.

And ICMJE still has its Obligation to Register Clinical Trials. As a condition of publication in their journals, the trial being considered must be in a public trials registry. Also is the Obligation to Publish Negative Studies, which is self-explanatory.

There is a current controversy on clinical trials registries, that pharma has not met the requirements of FDAAA for supplying all clinical trial data to clinicaltrials.gov within one year of trial completion. At the center of this requirement is the need for data sharing with the public and the medical research community, as well as transparency with pharmaceutical companies. While this debate goes to the heart of Dr. Bauchner’s argument that clinical trial reporting standards have advanced and there is increasing data transparency; many have determined that the problem of missing trial data in public registries, as well as non-enforcement of the mandates for full disclosure is hindering all of medical research.

In rebuff, others in pharma believe that dumping data into a system without context is confusing for the public and opens up a can of IP issues. And still others think that the critics have gone too far.

I maintain that clinicaltrials.gov is not designed for what all of the participants want it to do, and the issues of ease and input for data into clinicaltrials.gov is a technology and infrastructure problem. Maybe you are like Dr. Bauchner, with faith in a system that continues to self-regulate (along with outright regulation) and improve with technological advancements, or maybe you are like the many who see pharma as hiding and masking information, or like me who thinks the underlying issues are systemic to an industry in the midst of flux.

Whatever you believe, watch the journal editors and ask yourself what you think their agenda is. They shape editorial policy and can leave long legacies. Look at the Washington Post. Not a medical publication by any stretch, but with a bastion of respect akin to JAMA. Even Jeff Bezos, who just purchased the Washington Post, stated he doesn’t want to mess with the reputation, just improve the process. What Dr. Bauchner is announcing is the change in their policy is because it has been measured not to affect the end result. Sometimes change in process is for the better.
 

 

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