Here’s a useful paper we’ve just published in the BMJ, documenting problems in transparency around approval processes for randomised trials. There’s a basic rule in clinical research: you’re only supposed to do a trial comparing two treatments when you really don’t know which one is best, otherwise you’d be knowingly randomising half your participants to an inferior treatment. Despite this, it’s already known that trials are sometimes conducted where one group get a substandard treatment.
We wanted to find out how ethics committees come to approve such trials. We also wanted to know whether the patients participating in these trials were told, in either the consent form or the patient information sheet, that they might get a treatment below the usual standard of care. It’s possible, after all, that some people might be so altruistic that they’re happy to be exposed to harm, in order to generate knowledge.
What we found was, in my view, more concerning than a few questionable trials. Many of the drug companies, sponsors, institutions and ethics committees involved in the trials we examined were reluctant to share any of these documents at all. When we finally obtained documentary evidence of the discussions at ethics committees, we found superficial discussion, with these research regulators apparently convinced by some very weak evidence.
These kinds of shortcomings are much easier to get away with if your work, as a regulator, is all behind closed doors. Furthermore all this secrecy means nobody can observe, and then learn from, either your good practice or your mistakes. Meanwhile, the secrecy serves no positive purpose.
The irony, of course, is that researchers are forced to jump through endlessly time-consuming hoops to get even low-risk research approved by ethics committees. At the very least, we should be able to expect that the job is then done well, and transparently.
Overall, the novel take-home message is this: trials transparency is about much more than just the results of studies. That’s why we’re aiming to gather together all documents about all trials at OpenTrials.net (blog, paper) to make all such documents discoverable, drive up the expectation that such documents should be shared, and answer the question “where should they be posted?”.
So there you go. There’s lots of details, lots of slightly appalling eddies within the stories of individual trials, so do please read the full paper, which should be perfectly intelligible to any interested nerd. I hope that others will do follow-on work to explore whether they can obtain ethics approval paperwork – or copies of the blank consent forms given to patients – on other trials.