By Professor Carl Heneghan, Director, Centre for Evidence-Based Medicine, Oxford, co-founding organisation of the AllTrials campaign
As 2014 comes to an end, I thought a recap of the achievements of the AllTrials campaign this year would be worthwhile. If you are still wondering what AllTrials is about, well, where have you been?
You may have missed the fact that 532 organisations have signed up as supporters; we reached the milestone of 80,000 individual supporters in September. It’s probably time you told someone else to sign up – you’ll be in good company.
AllTrials began the year learning that the UK’s medicines regulator was into shredding clinical trial information, and a BMJ editorial, by me and Ben Goldacre, argued that most of our problems could probably be sorted by auditing whether a treatment’s clinical trials were registered.
In March we welcomed Dalhousie students who formed an AllTrials student society and immediately asked one of the major cancer networks to sign up. As a result the Canadian Cancer Research Alliance and Canadian Cancer Society became AllTrials members.
In April, Members of the European Parliament voted to adopt the new Clinical Trials Regulation – no this wasn’t an April’s fool. It now means clinical study reports of trials are not considered commercially confidential. Furthermore, all drug trials in Europe need to be registered before they begin and a summary of the results published within a year of the trial’s end. A number of politicians have been central to achieving this aim: Glenis Willmott MEP firmly led the fight on changing EU regulation. “The current situation is unacceptable,” she said. I couldn’t agree more.
Oh, and also in April, something about a drug called Tamiflu, missing data, and a heap of cash spent by governments – that might have been a waste of money – made the headlines.
In June, Vanessa’s Law was brought into being as Canada made the bold step of ensuring clinical trial information is made publicly available. AllTrials wrote to the Canadian Minister of Health to ask for an open public consultation on what exactly should be included in their new regulations. And in the same month, the European Medicines Agency (EMA) also decided to change its data sharing policy, largely, we think, because a lot of AllTrials supporters sent correspondence criticising their policy.
There must have been a good feel factor in June, as pharmaceutical company Bristol-Myers Squibb announced it would provide access to its clinical trial data going back to January 2008. They joined Johnson & Johnson who made a similar announcement in January, as well as GSK, Eli-Lilly and Boehringer-Ingelheim who decided to share their data through ClinicalStudyDataRequest.com. If you are still working for a company that hasn’t yet signed up – and we know who you are – it’s about time you made an issue out of it.
Also in June student power came to the fore, as the University of Edinburgh became the first Scottish university to sign up to AllTrials at the request of one of its students. It joins Cardiff University, Dartmouth College, Hull York Medical School, Kings College London, Bond University and London School of Hygiene and Tropical Medicine. In September, the Open University – the largest academic institution in the UK – also joined AllTrials.
In the US lawmakers were obviously getting hot under the collar: 22 of them wrote a letter in June calling on the National Institutes of Health to publicly disclose information on the sex and ethnicity of participants in all registered clinical trials.
By July, the UK’s Health Research Authority waded in with strong proposals to encourage researchers to register clinical trials and report research results. Their proposals mean the track record of researchers applying for ethical approval to conduct clinical trials will be checked to see whether they have complied with transparency and reporting standards in past. In the same month we also depressingly found out that, out of a sample of 400 completed trials registered on ClinicalTrials.gov, 30% haven’t reported their results.
David Haslam, the chair of NICE, told UK MPs on the House of Commons Health Select Committee that when clinical trial results are kept hidden, the contribution of patients gets ignored. At the hearing in September, MPs were told there was a “moral imperative” for all trials results to be published.
In October the UK’s Health Research Authority published the feedback it received to its clinical trial transparency proposals. If you are still looking for a good reason to support trial transparency then the following personal story by Elizabeth, aged 39, provides a compelling narrative:
‘I have a brain tumour that will mean I die prematurely, potentially at around age 40. Brain tumours are a rare form of cancer and because they affect the young, are the form of cancer to which the most years of life are lost compared to other forms of cancer.
A problem with treating brain tumours is they come in many different types which means very limited funding is horrendously stretched and the incentives for research are low because while finding better treatments would mean more years of life are returned to patients, quite bespoke treatments need to be developed for each form. Unfortunately one size doesn’t fit all. This means a lot of research is required and with so little funding, the value of enabling researchers to build on existing studies is knowledge, and to avoid spending money duplicating similar studies would be immense.
As a personal testimony, I was diagnosed with cancer a few years ago and given a life expectancy of 6-10 years. Having experienced a premature menopause as a result of chemotherapy, I will not be able to have a family even had I reconciled my ethical dilemmas about this. It’s a diagnosis that affects my partner who will not be able to have a family either, and my parents who will experience the death of their child and the lack of grandchildren. I will not have the opportunity to enjoy retirement.
For these reasons, I fully support proposals which will make a difference to the amount of clinical research finding available and urge you to do all you can to speed up scientific discovery cost effectively by ensuring researchers can build on knowledge that exists.’
Also in October, the World Health Organisation came to the party, having decided to formulate a draft policy on Public Disclosure of Clinical Trial Results. This follows on from the establishment of the International Clinical Trials Registry Platform. And having founded the platform guess what they found: ‘more work was needed to ensure that trials were registered and their results made available.’
So, by the end of the year what did we learn? The problem of trial transparency is still out there and not in any way solved: 27% of clinical trials on surgical techniques remain hidden according to a BMJ study published in December. We also learnt that individuals and organisations can overturn important regulatory powerhouses such as the EMA and lead to the WHO taking action.
And what now for 2015? Well, you could start the New Year by adding your voice to two US proposals to tackle the problem of hidden clinical trials.
Happy Christmas and thanks for your support. Oh, one last thing, consider signing up if you haven’t already.
Carl Heneghan and the AllTrials team