Ben Goldacre is a doctor, writer, academic and campaigner well known for his Bad Science columns in the UK Guardian newspaper, and for his books Bad Science, and Bad Pharma. Most recently, Goldacre has spearheaded the AllTrials campaign, calling for the publication of all trial results regardless of outcome to ensure the most transparent reporting of clinical research.
In this Q&A for BioMed Central to mark International Clinical Trials Day, Dr Goldacre discusses why we need the AllTrials campaign, its successes so far, and what the campaign hopes to achieve.
Tell us a bit about the origins of the AllTrials campaign – what pushed you to start the campaign?
After publishing Bad Pharma, I was astonished to see the Association of the British Pharmaceutical Industry claim that all the issues raised in the book were historic, and that they had all been long addressed. This was clearly untrue. Speaking more broadly, it is clear that there has long been a concerted effort to brush the issue of missing trial results under the carpet, over the three decades since it was first documented in medicine, with a worrying history of inaction among senior doctors and academics. I discussed this with Simon Singh, the science writer, and he kindly donated £5k to Sense About Science, to pay for an intern to work on a campaign around this issue. From there, in just a few months, it has snowballed to 50,000 signatures, 250 organisations, and real policy work.
Why is it important to publish all clinical trial results, regardless of outcome?
Doctors, patients, payers, and researchers need access to all the results, of all the trials that have been conducted on a treatment, in order to make informed decisions about which is best. The idea that trial results should be withheld is ludicrous, it simply breaks evidence based medicine, and exposes the medical profession to justified mockery.
Glaxo Smith Kline made the big announcement earlier this year that the results of all of their clinical trials will be made publicly available. What impact will this have?
Firstly, they have shown clear leadership on this vitally important ethical issue: while others, such as PhRMA, have claimed that our calls for transparency are unethical and impossible, GSK have committed to getting on and sharing all results, in very practical terms. Other companies, in failing to make that commitment – but also in failing to publicly acknowledge the problem – have taken a reputational hit.
More than that, though, I think as more companies sign up, and assuming they deliver on their promises, this could become a factor in treatment decisions. Imagine there are two apparently equivalent treatments: one is made by a company with a proven track record of sharing all results, and a public commitment to doing so; the other is made by a company who have not only failed to commit to sharing all trial information, but have mocked and derided the very notion that anyone should dare to ask. I don’t think those two treatments really are equivalent, I think rational doctors and patients will choose the treatment they can trust more. So paradoxically, although this problem needs legislation to fix it, market differentiation with respect to transparency could actively create a financial incentive for transparency.
Do you think the other pharmaceutical giants will follow suit?
I can’t say any more at present, but yes. The reputation gains are enormous, many have made commitments that are close to AllTrials, but this issue is only going one way. It’s such a simple and unarguable commitment that AllTrials requires. Companies that fail to sign up are increasingly looking – frankly – questionable.
How important is it that patients – those that partake in clinical trials, and those that benefit from the results – understand what this research means?
Participants are free to choose to be ignorant, but where they want to be informed, we must do all we can to meet those needs. We can only improve recruitment by making patients more aware of how research works, and by fixing these glaring ethical problems.
With internet resources, and groups such as Patients Like Me, patients are becoming increasingly educated. How do you think patient knowledge can be utilised, and trial participants further empowered in the trial process?
As I argue in Bad Pharma, the information architecture of evidence based medicine is profoundly flawed, we fail to join the dots, and this extends way beyond any simplistic notion of industry behaving badly. Research needs to be embedded in routine clinical care, as a matter of course. Evidence dissemination – making best use of the evidence we already have – needs to be a much higher priority, even if it is less glamorous and rewarding on the CV than doing one trial.
The AllTrials campaign calls on governments, regulators and research bodies to implement measures to make trial data and methodology, past and present, available. Their requests are beginning to be heard: the UK Health Research Authority recently announced plans for promoting transparency in research, with measures such as including the registration of clinical trials being a requirement for ethical approval from their Research Ethics Commitees. BioMed Central welcomes this announcement, to encourage transparency the journal Trials (and other BioMed Central journals that publish trials and trial protocols) already require authors to register their clinical trials as a condition of submission. BioMed Central also runs Current Controlled Trials on the behalf of ISRCTN, the UK’s trial registration service which lists trials awaiting or receiving full ethical approval.