BMJ to require clinical trial data be made available
I’ve been following with interest the British Medical Journal‘s bold new move to refuse to publish research on drugs unless the clinical trial data is made available for independent analysis from January 2013. This is great news for other researchers, scientists and statisticians wanting to independently analyse and verify findings from studies.
In an editorial, the journal says they want to “leverage their power and publish only where there is a commitment to make the relevant anonymised patient level data available on reasonable request.” Further, they are campaigning for open data using Tamiflu as an important case study after being frustrated with years of trying to get drug company Roche to fulfill its promise to release full clinical trial results.
The BMJ quotes Ben Goldacre’s new book Bad Pharma:
“Drug companies around the world have produced some of the most amazing innovations of the past fifty years, saving lives on an epic scale. But that does not allow them to hide data, mislead doctors, and harm patients.”
Goldacre is one of a group of campaigners in the UK currently pushing the government to legislate for true transparency regarding clinical trials.
Watch a recent TED video from Ben Goldacre on the other “scandalous” problem of unreported trials of negative or inconclusive drug trial findings:
I believe Media Watch will be covering this story this weekend too.
Ben’s blog, Bad Science is always excellent reading, and I am looking forward to reading his newest book and hope that the BMJ’s campaign is successful.
Rachel Cunliffe is the co-director of CensusAtSchool and currently consults for the Department of Statistics. Her interests include statistical literacy, social media and blogging. See all posts by Rachel Cunliffe »
I agee completely with the goal of having clinical trial data transparent. However, having worked on fairly modest clinical trials (about 1000 patients, 3 years duration) I know that the analysis of this data is a lot of work. It took months to analyse the complete trial data. Would anyone really have the time and energy to re-analyse a trial? Especially if you gain nothing by finding exactly what the authors publish?
If we asked for the raw collected data to be submitted, you would also need pages and pages of documentation on analysis algorithms, rules for inclusion and exclusion of patients, definintions of derived variables, etc. If we ask the original authors to just publish the analysis ready files with all these calculations already done, patients already excluded, etc, they can hide as much as they can when they just give you the already analysed paper.
I am not sure that this would solve any of the underlying problems.
12 years ago
Anne, the point is that hiding the data behind the CSR eliminates the possibility of someone pursuing such a re-analysis – we generally regard hiding stuff as a “bad thing”. And yes, generally it’s unlikely that many will have the inclination to do this. However, from time to time someone like the Cochrane Collaboration may set out to do a Systematic Review, and the difference between having study-level and individual-level data for such a meta-analysis is enormous.
Is there an inherent problem with submitting pages and pages of documentation, inclusion/exclusion rules etc? These are really important information that go directly to the generalisability of results. In trials, typically, we exclude the really sick, the very young, the very old, the pregnant etc – if someone is contemplating prescribing the drug on the basis of this trial, isn’t this absolutely relevant information that should be in the public domain?
A further point emphasised by Ben G in the book is the necessity to have all the negative results available.
Solving the underlying problems is a big problem – complete and open publication of trial data, including the CSR and statistical analysis plan are a step in the right direction, in my opinion.
12 years ago
Another great post Rachel. Not to imply others aren’t posting high quality material too. As a relatively new member I am really enjoying this site. Well done.
12 years ago
Thanks Godfrey, I appreciate your feedback!
12 years ago