Are clinical trial data shared sufficiently today? YesBMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f1881 (Published 09 July 2013) Cite this as: BMJ 2013;347:f1881
All rapid responses
"an ounce of data is worth a thousand pounds of opinion." (1)
1. Unpublished US phase 3 trials.
2. About the 8 novel drugs approved by the FDA in 2013
3. It's relatively easy to disclose anonymized patient level raw data of a clinical trial.(2)
4. About patient privacy concerns: could anyone identify at least one patient in data disclosed above?
1. Ashish Jha. An Ounce of Evidence. Health Policy Blog. Harvard University.
Date accessed: Aug 13, 2014
2. Ramirez JH, Arce R, Contreras A, et al. Periodontal therapy does not improve cardiovascular disease biomarkers: results of a randomized clinical trial. figshare.
Competing interests: I endorse the principles of open data
1. Re-identification of patients is unlikely unless you're reporting case studies or small pilot trials of new drugs. Even then, we already publish trial data on n=9 studies. Using this as an argument against publishing all trial findings that don't favor the drugs pharmaceutical companies want to push is specious.
2. 'Dumping' trial data in a public place where it can be freely accessed and reviewed won't undermine anything. It will more likely improve understanding of actual drug impacts and effects (the horror). As the head of PhRMA, the author must know that there are already, and have been for some two decades, statistical guidelines on how to properly conduct meta analysis and review clinical trial data evidence. We have entire university degrees dedicated to statistics. Another specious argument.
On the other hand, maybe it ought to undermine current understanding of drug treatments. The better to enlighten doctors and patients as to what they're prescribing/taking.
Furthermore, it's far too convenient for companies simply not to publish drug trials that show no significant effect from placebo. I'm aware of a few drugs that have undergone several trials, yet only one or two had the results published. I'm left with the impression that the company figured out from earlier 'failures' (no significant difference to placebo/best alternative care) how to structure the trial to get the necessary statistical outcome, and then published the most favorable results.
3. Competition & intellectual property. This is really the only argument that makes sense. Drug companies aren't in the market to make people feel good. Its a multi-billion dollar industry, of course they're in it for the money. There's little incentive to invest otherwise.
Of course, that being said, what patient or government really wants to approve a drug that might not do what companies claim it can do? Given this, perhaps instead of complete and utter public transparency, all trial data must be submitted to government in order to have the drug approved for use. At least then regulators would have had all the necessary information (kept commercial-in-confidence) to make that decision. Otherwise, what is the point of regulating drugs if companies can simply hide away undesirable results?
Competing interests: No competing interests
It is hard to believe that the president and chief executive officer of the Pharmaceutical Research and Manufacturers of America does not have competing interests.
Competing interests: As an author of systematic reviews I would benefit from improved availability of clinical trial data.
There is very little I can add to this discussion, except to say the pharmaceutical industry is clearly correct in its stance. It is unreasonable of the scientific community to expect researchers to keep track of all these pesky details and then publish them. It is already hard enough to track all these drug interactions - publishing details of how studies were done is clearly a bridge too far.
Studying drugs that are to be used in humans is an expensive, time-consuming process. Why would anyone want to have to show how they reached their conclusions? Then there are privacy concerns. How can we be expected to keep patient confidentiality if we are going to publish the details of double-blinded studies. Wait, did I say double-blinded? Oh, yeah - but it's still really, really hard to keep privacy while publishing what we really did. As opposed to keeping privacy while not actually showing what we did.
Yep, the industry's right. Requiring them to show how they got to the answer on their homework is crazy talk.
Competing interests: Rely on the efficacy and safety of modern pharmaceuticals.