The medical research community has known about the problem of missing clinical trials for decades. However, across Europe, there has been very little tangible progress on the issue. Relevantly, a just released British initiative, as reported in this article, could serve as ‘take-home’ message and pave the way for medical researchers, doctors and patients in Italy and other European countries to speak up and demand that politicians, funding agencies and other public institutions take action to finally resolve this problem
By Till Bruckner, PhD
Founder of TranspariMED
An Initiative that Works to End Evidence Distortion in Medicine
The UK is Finally Cracking Down on Unreported Clinical Trials
Now Other European Countries Must Take Action Too
On 30 October, a British parliamentary committee released a report calling on the government to launch a “national audit programme of clinical trials transparency” and impose sanctions on institutions and individuals who fail to register trials or report their results. If adopted by the government, the committee’s recommendations will ensure that every single clinical trial conducted within the UK is registered and publishes its results.
European countries can learn a lot from the British example.
While the UK government has yet to issue a formal response, the report has already had a strong impact on universities and other public institutions in the country. Several universities have begun reviewing their policies and processes, and in some cases are systematically uploading all missing results onto trial registries. Some National Health Service Trusts are reportedly also starting to review their trial registry entries.
The committee proposed using records by the UK’s Research Ethics Committees to check whether trials have been registered and reported. As ethics approval is required to run any clinical trial in the UK, ethics approval documents capture each and every trial conducted within the country. The Health Research Authority in London already centrally collects all ethics approval documents, so the audit programme would not impose additional costs or bureaucracy on trial sponsors or investigators.
In addition, the committee proposed changing the law so that fines can be imposed on pharma companies, universities and public bodies that fail to post trial results onto trial registries. The Health Research Authority has already declared its willingness to impose sanctions.
The cost of the programme is estimated to be a maximum of £2.4 million per year – a tiny amount compared to the £424 million the National Health Service misspent on Tamiflu before data from eight previously hidden trials showed the drug to be essentially useless. (Other estimates put the programme’s cost as low as £150,000.) As the committee noted, “this is a small price to pay compared with the sums of money involved in policy decisions that draw on clinical trials evidence”.
Compared to the UK, other European countries are still lagging far behind in clinical trial transparency. According to data aggregated by the EU Trials Tracker, an online tool, European universities in particular have a terrible track record at posting trial results onto EudraCT, the European trial registry. A full 89% of trials sponsored by European universities are currently missing results there.
For example, Agostino Gemelli University Polyclinic, Vita-Salute San Raffaele University, and even the Istituto di Richerche Farmacologiche Mario Negri have not posted a single trial result.
Some observers assume that the problem will be resolved when the EU Clinical Trials Regulation comes into force in late 2019 or early 2020. Sadly, this assumption is mistaken. While the regulation will require all trial sponsors to post the results of some trials onto EudraCT within 12 months of trial completion (6 months for paediatric trials), there are two important caveats.
First, enforcement of the regulation will be the responsibility of individual EU member states. I am not aware of any member state that is currently preparing to impose fines once the regulation comes into force. Unless these changes, the regulation will remain a toothless paper tiger.
Second, the regulation only covers a minority of clinical trials, so-called ‘CTIMPs’. Most trials conducted in Europe – including all trials of medical devices, non-drug treatments, and Phase IV trials – are not CTIMPs, and are therefore not covered by the regulation (note that these trials cannot be registered on EudraCT and are thus often listed on other registries such as Clinicaltrials.gov.). So even if member states enforce the regulation, the results of many trials of great importance to patients, clinicians, and public health institutions are likely to remain invisible.
So what can medical researchers in Italy and other European countries do? Below are three simple steps.
- Talk publicly about this problem, and how it can be fixed
The debate around hidden clinical trials is far more advanced in the UK than in other European countries. This is not a coincidence. Dr Ben Goldacre, a campaigning doctor, has worked tirelessly for years to bring the issue to the attention of British policy makers and the public. Thanks to his efforts, research funders, universities, and even companies based in the UK routinely top global transparency rankings. In addition, we now know how to fix this problem: we need effective national monitoring plus real sanctions.
- Ask politicians to stop wasting public money
Policy makers are extremely busy and may struggle to understand how missing clinical trials affect systematic reviews and meta-analyses, and why that matters. Ethical arguments too can fail to resonate. In contrast, when you point out that public money is being spent on medical research that does not report results, and that this money is being completely wasted, policy makers start to listen. Requiring all clinical trials to post their results onto registries within 12 months is a common-sense solution that can improve public health at virtually no cost – an attractive message for political leaders.
- Challenge public institutions to curb research waste
National laws should require all trial sponsors to post their results. However, new laws can take a long time to draft, adopt and enforce. In the meantime, strong impact can also be achieved by insisting that medical research funders ensure that all clinical trials supported by tax money post their results within 12 months. For example, the Italian Ministry of Health has not yet signed up to World Health Organization best practices in trial transparency. It should be encouraged to immediately do so. Equally, universities and public institutions should be publicly challenged on their trial reporting performance and be encouraged to fix the problem. The EU Trials Tracker makes it easy to discover who is posting their trial results – and who is not.
The medical research community has known about the problem of missing clinical trials for decades. However, across Europe, there has been very little tangible progress on the issue. It is high time for medical researchers, doctors and patients in Italy and other European countries to speak up and demand that politicians, funding agencies and other public institutions take action to finally resolve this problem.
By the same Author on PEAH
tillbruckner@gmail.com