Overhauling Industry-Sponsored Studies

[GRAMMY]

Overhauling Industry-Sponsored Studies
Major pharmaceutical companies have agreed to a handful of recommendations aimed at increasing the transparency of clinical trials they fund.





All clinical trial findings—even negative ones—will be made public, author contributions to manuscripts will be made clear, and study authors will have full access to all trial data in industry-funded clinical trials if a list of recommendations hashed out by editors at top medical journals and eight major pharmaceutical companies are actually implemented.
A team of 11 authors from the worlds of Big Pharma and biomedical publishing listed 10 such recommendations in a recent article that ran in the current issue of Mayo Clinic Proceedings. The recommendations arose from the Medical Publishing Insights and Practices Initiative, launched in 2008, which includes input from representatives at Merck, Amgen, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Pfizer, and Takeda, as well as editors from 65 biomedical journals, among them The Lancet and the Journal of Clinical Oncology, and other members of the International Society for Medical Publication Professionals.
The eight pharmaceutical companies all affirmed their commitment to the recommendations, such as ensuring that clinical studies and publications address clinically important questions, improving understanding and disclosure of authors’ potential conflicts of interest, educating authors on how to develop quality manuscripts and meet journal expectations, reporting adverse event data more transparently and in a more clinically meaningful manner, and transparently reporting statistical methods used in analyses, among others.
But the proof of Big Pharma’s commitment to these principles will, as always, be in the pudding. “The [recommendations] all seem fine,” Jerome Kassirer, former editor-in-chief of The New England Journal of Medicine told American Medical News. “The question is whether the pharmaceutical companies will practice what they preach. They don’t always do this, as is evident from the multiple multimillion-dollar suits we hear about, year after year.”

http://the-scientist.com/2012/05/23/...mber_117958376

[Jack32]

That's certainly an interesting debate. For my sake and many other patients who've participated in clinical trials, there's a fine line between transparency of an individual's results from a session (although I may be reading too much into this) and informing the general public on the pros/cons of experimental medications that are either pending FDA approval or have yet to make it to that stage.

I was reading about certain stats on clinical trials from a panel of patients and non-patients on their feelings with clinical trials and how much they've benefited, how outsiders view their success and so forth.

The results came from the Center For Information & Study on Clinical Reserach Participation (CISCRP)

http://www.ciscrp.org/professional/facts_pat.html

Great read, nonetheless.

[GRAMMY]

Thank you for the link Jack32. I think the main issue is one that is raised on the linked site you posted.

"More than anything else, study volunteers want to know that their participation mattered. Regardless of the outcome, people who participated in clinical research want assurance that something was learned from their contribution that will inform medical knowledge about disease and how to treat it.
Unfortunately only 14% of study volunteers believe that drug companies will eventually disseminate all information—positive or negative—about an investigational treatment. Once a clinical trial has ended, 86% of study volunteers say that they never learn about their clinical trial results. Very few participants hear from study staff (e.g. the principal investigator and study coordinator) – or any party – once their participation has ended".

http://www.ciscrp.org/professional/trialresults.html

[zillazangel]

As an author of many industry sponsored studies, I have watched this issue for years. Increased transparency is good for everyone.

[GRAMMY]

Let us hope that the recommendations are indeed implemented!

[Sue Pendleton]

I wish they'd take that transparency down to the large animal level. First, vets would have a ton of more meds in their arsenal to use on mainly companion animals and owners would know if a drug being developed for human use didn't make the grade, the results vaguely rewritten, and resulted in a less than good drug for, say, dogs was approved by the FDA Vet group. There are basicalky 2 pain meds approved for dogs only and one came from a failed human based attempt for approval. I wouldn't give that to another dog on a bet after my last was on it for 2 weeks.

And in the pill clinical trial I was in I was contacted after the results were unblinded about a year after my participation. Between the trial and the final results I did get a few follow up calls from the main RN in charge of the patient records to see if I was having any unusual health events? lol In other words, anything good or bad happening since the trial ended for me? And yes, that is important.