Every year thousands of patients participate in clinical trials in the hope of helping doctors to find better treatments for their disease. Indeed, clinical trials are essential in medicine to compare treatments and provide the safest and most effective cure to patients. Doctors and researchers need to have a clear and broad picture of all results – positive and negative – obtained in those trials in order to understand which treatment is best for their patients. And yet, almost half of the drugs and treatments we are prescribed today are based on trials that never reported their results.
In the US alone, where trials are registered in the portal ClinicalTrials.gov, of the 29,377 trials that were completed between 2006 and 2015, 45.2% haven’t published their results(1,2). How is this possible? Aren’t there any laws that require sponsors and research institution to publish the outcomes of trials? Well, sort of.
In the US, the FDA Amendment Act 2007 requires that only certain trials performed in the States are recorded on ClinicalTrials.gov and results are reported within 12 months after the trial conclusion; the American government can even impose a fine of up to $10,000/day for those who don’t publish their results. As of today, 510 out of 806 trials (63.3%) have been reported, and $0 of fines has been claimed by the US government – who could impose fines for almost $242 million(3). In Europe, the EU regulation 536/2014 says that “all clinical trials should be registered in the EU database prior to being started” and that “the results of the clinical trial should be reported within one year from the end of the clinical trial”; the regulation also contemplates the application of penalties in case of violations. Although it entered into force in 2014, this rule is based on the development of a fully functional EU clinical trials portal and database, so it will be applied only from 2019.
Many medical research funding institutions, such as the European Commission and the US National Health Institute, require the publication of the results of the trials they fund but fail to enforce and control this demand.
Besides the problem of no reporting, there is also the issue of bad reporting. In order to understand the results of a clinical trial, doctors and researchers need to know what outcomes were measured and how – this is essential to provide relevant and appropriate treatment to patients in real clinical settings. The set of outcomes to be analyzed and the methods to measure them are defined before the trial starts. Unfortunately, often the trials’ outcomes are poorly selected, registered and described, so the trial can’t make a significant contribution to patients’ care(4). In addition, many researchers don’t publish the results defined at the beginning of the study, and instead, report on different outcomes, therefore providing an overstated and biased image of the benefits and risks associated with the treatment that was studied(5).
This whole situation damages medicine and patients: doctors and researchers don’t have all the information they need to make the most appropriate decisions in healthcare, while patients don’t get the most effective treatment and lose trust in trials. Money and time are wasted in research that may have already been done, or in treatments that are not effective enough.
But things are getting better, and thanks to AllTrials the situation has already improved.
AllTrials is a campaign that demands all past and present clinical trials to be registered and their results reported. It was started in 2013 by Ben Goldacre (physician, researcher, and science journalist), BMJ, Centre for Evidence-based Medicine, Cochrane, James Lind Initiative, PLOS and Sense about Science, and currently it is supported by more than 93,000 individuals and 740 organizations. By raising awareness on the problem of unreported clinical trials, the campaign is slowly changing things.
In 2015 the World Health Organization (WHO) published a statement on the public disclosure of clinical trial results, calling for unpublished trials to be reported. In a report published the following year, the United Nations also required that “data on all completed and discontinued clinical trials be made publicly available […] regardless of whether their results are positive, negative, neutral or inconclusive”. In 2017, 21 organizations – including the European Commission, Bill and Melinda Gates Foundation, and Médecins Sans Frontières – released a joint statement in which they pledged to develop and implement a policy to register and publicly disclose the results of the clinical trials that they funded, co-founded, sponsored or supported.
AllTrials is currently auditing those signatories’ organization to check if they’ve kept their promise. In addition, the campaign has developed FDAAA Trials Tracker, an online platform to monitor which clinical trials are reporting their results in the US, and every week it publishes a paper describing an unreported clinical trial in the BMJ.
Knowing the results of all clinical trials will move medicine forward, allowing researchers and doctors to improve healthcare and providing patients with the best and safest treatments available. A lot still needs to be done, and we can all give our contribution. You can support the AllTrials campaign in many ways: sign the petition, ask your organization to join, donate, or simply tell others about it. We can all do something to fix this huge problem.
 https://trialstracker.ebmdatalab.net  Powell-Smith A and Goldacre B. The TrialsTracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions [version 1; referees: 2 approved]. F1000Research 2016, 5:2629  http://fdaaa.trialstracker.net/  Heneghan C, Goldacre B, Mahtani KR. Why clinical trial outcomes fail to translate into benefits for patients. Trials 2017, 18:122  http://compare-trials.org/
Last modified: December 4, 2018