It’s soon going to be the law in Europe that drug clinical trials are publicly registered and results reported. MEPs have today voted by a huge majority to adopt the Clinical Trials Regulation, 547 in favour and 17 against. This is fantastic. It will mean that researchers will in future know about trials as they are happening and will be able to scrutinize results soon after their end. This is all due to the efforts of people all over Europe, including many patients who took part in clinical trials, who have pressed their MEPs to set the future straight in this way. Now we want to see recognition and use of the contribution that they and thousands of others have made in the trials that have already been conducted.
The new Clinical Trials Regulation says that information from Clinical Study Reports of trials should not generally be considered commercially confidential and will:
• Require that all drug trials in Europe are registered before they begin on the publicly accessible EU clinical trials register.
• Require that a summary of the results from these trials is published on the register within a year of the trial’s end.
• Require that a summary understandable to a lay person of what was found in the trial is published on the register.
• Require Clinical Study Reports (detailed documents normally produced for regulatory processes) to be made publicly available, where they are produced.
• Establish a new publicly accessible EU clinical trials register, to be set up and run by the European Medicines Agency.
• Require that all trials used in support of an application to run a new clinical trial are registered or have published results.
• Impose financial penalties on anyone running a clinical trial who does not adhere to these new laws.
Dr Ben Goldacre, author of Bad Pharma and co-founder of AllTrials said: “This is an excellent small step forward after some really good work by MEPs. But the new EU legislation is only concerned with new trials. It does not address the far bigger problem, that we still don’t have full reporting for all trials on the medicines we are using right now, today, medicines which we will continue to use for the foreseeable future. Doctors and patients simply cannot make informed decisions about which treatment is best, when the evidence on the treatments they are using is still being routinely and legally withheld. We need all trials – on all uses of all currently prescribed treatments – to be made available, and urgently. There is no excuse for industry inflicting ongoing harm on patients, and on their own reputation, by continuing to campaign against this position. They should join their more ethical colleagues, and sign up to the AllTrials.net pledge.”
Congratulations to Glenis Willmott MEP who led the negotiations on the Regulation and fought for transparency to be at the heart of the new law. Following the positive vote in Parliament, the Regulation now has to be formally adopted by Council and published in the Official Journal. It is expected to come into effect in mid-2016 at the earliest and then all EU member states will adopt the laws into their own statutes. The European Medicines Agency can now start building the new publicly accessible online clinical trial database.
Clinical trials: clearer rules, better protection for patients – European Parliament News
MEPs back new clinical trial rules – European Voice
Europe Moves to Make Drug Trial Data More Transparent – Bloomber Businessweek
Q&A: New rules for clinical trials conducted in the EU – European Commission Memo
EU votes for trial transparency – Pharmafile
New EU Regulation on clinical trials agreed at EU level – NHS Confederation
Clinical trials vote is a triumph for transparency in EU healthcare – European Ombudsman
MEPs vote for more transparent and simpler European clinical trial rules – The Pharma Letter
Síle Lane, Director of Campaigns, Sense About Science, co-founding organisation of the AllTrials campaign: “Huge congratulations are due to the people all over Europe, including many patients who took part in clinical trials, who have pressed their MEPs to set the future straight in this way. Now we want to see recognition and use of the contribution that hundreds of thousands of people have made in trials that have already been conducted but never published results. We have to make their efforts count.”
Richard Stephens, patient and clinical trial participant: “The new legislation is good news for patients in the future. But as a patient now, I know that I am being given treatments and medicines based on research that has not been made public. I hope that all funders and sponsors of research will publish the results of their research over the past 20 years, so that we can evaluate it in the same way that we will evaluate the research of the future. As a trial participant myself, I would ask everyone who has joined a trial anywhere in Europe to ask when and where the results will be made openly available, and I would ask every European ethics committee to make sure that open and accessible publication of results is made a requirement before researchers are allowed to conduct experiments on patients.”
Professor Carl Heneghan, Director, Centre for Evidence-based Medicine, Oxford, co-founding organisation of the AllTrials campaign: “The success of the EU clinical trials regulation vote is one step towards guaranteeing novel treatments are based on all of the available evidence. The regulation, passed today, ensures that new trials are registered, and their results will be published in a timely manner. For patients, this means future treatments are likely to be effective and safe. However, there is a need to carry on with the campaign, in that, clinical trials done on medicines in current practice pre-date this regulation; and much of the evidence base for these treatments is simply missing or incomplete, which is unacceptable.”
Dr Trish Groves, Deputy-Editor BMJ, co-founding organisation of the AllTrials campaign: “Having methods and results of all drug trials in the public domain is a big advance and discussions have already started about the practicalities, upsides, and what some may see as potential downsides of sharing this information. It’s time for medical educators, investigators, funders, sponsors, ethics committees, and most importantly – trial participants – to prepare for an era of much greater openness.”
Dr Virginia Barbour, Editorial Director, PLOS Medicine, co-founding organisation of the AllTrials campaign: “With this vote, the European Parliament is demonstrating leadership in legislating for the reporting and registering of new trials and this will be closely watched by legislators worldwide. This is a critical move, but the next step has to be further legislation to mandate full availability of all human trials, past and future.”
Dr Richard Lehman, GP: “As a general practitioner trying to advise patients on the best treatment to achieve the outcomes they want, I need complete information about harms and benefits. The legislation before the European parliament is a welcome step towards making this possible in the future. But at present, half the information we need to inform choices about treatments remains hidden. There are moves afoot by some manufacturers to release full data about trials of treatments already in use, but this legislation represents a lost opportunity for making this mandatory. As a result, patients and health professionals will continue to work with only part of the information they need and are entitled to have.”
Dr David Tovey, Editor-in-Chief, Cochrane Library, co-founding organisation of the AllTrials campaign: “Evidence informed healthcare decision making is one of the best ways to improve health. However, for the evidence to be the best quality, most trusted and most up-to-date, we need all clinical trials data to be made available to the researchers reviewing it. For Europe to sign up to a register and commit to reporting results it is a great step forward. Yet, there are currently many medicines in use where all trial data hasn’t been made available and without it we risk using ineffective and potentially harmful treatments and medications on the very people we want to help.”