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The Pioneers of Transparency

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The Pioneers of Transparency CLINICAL TRIALS thebmj.com n 1 January 2015 a watershed moment came for Ж Open data campaign: thebmj.com open data clinical trial transparency when a long awaited Ж Editor’s choice: Open data: seize the moment policy change at the European Medicines Agency (BMJ 2012;345:e7332) came into force. From this date all successful appli- Ж Editorial: Open access to industry’s clinically cations to the agency will lead to publication of the Orelevant trials’ clinical study reports. relevant data (BMJ 2004;329:64) The change of policy opens a new era of transparency that has been hard fought for, over many years, by many researchers and a few very committed policy makers.1 It will be followed, in May 2016, by the new European Union Clinical Trials Regulation, THE PIONEERS OF which says that the clinical information in clinical study reports should not be considered commercially confidential, thus remov- ing the legal argument that drug companies have used until now TRANSPARENCY to justify withholding large amounts of trial data. But many battles are still to be fought. For now, the European This year sees the first major step towards full Medicines Agency can still make restrictions and redactions if it considers data to be confidentially commercial (such as proprie- disclosure of clinical trial data in Europe. Here we hail the tary secrets about the drug molecule), although the regulator has determined campaigners who pushed for this for years emphasised that this is likely to happen only in a small number of cases.2 And the new legislation will not apply retrospectively and the powerful people who listened. By Ben Adams to data from drug applications made before 1 January 2015, THE PEOPLE WHO PUSHED FOR CHANGE PETER GØTZSCHE IAIN CHALMERS TOM JEFFERSON SILVIO GARATTINI AND ALESSANDRO LIBERATI Peter Gøtzsche, director of Since the 1980s the other Tom Jefferson and his Garattini and Liberati, both researchers at the Mario the Nordic Cochrane Centre cofounder of the Cochrane fellow Cochrane reviewers Negri Institute in Milan, have helped question attitudes and cofounder in 1993 of the Collaboration, Iain Chalmers, worked for years to try to get among academics as well as the drug industry. Liberati Cochrane Collaboration, has and his fellow researchers have access to data for Roche’s was a clinical epidemiologist and researcher who been working tirelessly for years been drawing attention to the H1N1 influenza treatment helped establish the Italian Cochrane Centre. He had to get the European Medicines issue of under‑reporting of oseltamivir (Tamiflu) and multiple myeloma and died on New Year’s Day in 2012, Agency to release more data.3‑5 research results, which he says GlaxoSmithKline’s flu at the age of 5715 In 2004 he wrote a personal view in Gøtzsche worked on clinical is “unscientific, unethical, and prevention drug zanamivir The BMJ talking of his disease and the uncertainties he trials and regulatory affairs uneconomic.”6 7 (Relenza). faced.16 He wrote, “Research results should be easily in the drug industry between At the beginning, he explains, Jefferson says, “In 2009 accessible to people who need to make decisions 1975 and 1983. Since 2007, “Our exhortations made virtually we’d never heard of clinical about their own health . Why was I forced to make my Gøtzsche says, he has come up no difference,” adding that no one study reports. The first decision knowing that information was somewhere but against much resistance and was interested, “least of all the glimpse of this hidden not available? Was the delay because the results were frustration, but all that changed researchers who were guilty of this universe came to us from less exciting than expected? in November 2012 when the misconduct.”8 This all changed an old Roche submission to “Unfortunately this is possible in a world where European Medicines Agency held with Ben Goldacre’s book Bad the UK National Institute for clinical research has become dominated by commercial a workshop at its headquarters Pharma and the resultant AllTrials Health and Care Excellence interests. When you are a patient you wonder how (we) that made history. Its new campaign, he says. “These (NICE) that had been leaked researchers can keep forgetting the principle that the head, Guido Rasi, started by have raised the profile of this to us. priority should be collaboration for better hypotheses, announcing, “We are not here to scandal, and we have begun “It contained fragments not competition.” decide if we will publish clinical to see tangible developments of four trials. Now, thanks Garattini is a member of the European Clinical trial data, only how.” towards greater transparency. to the Tamiflu saga, even Research Infrastructure Network (www.ecrin.org), a not “The industry representatives This is encouraging, but the battle politicians know about CSRs for profit clinical research project that was started in were stunned,” Gøtzsche recalls. remains far from won. I think [clinical study reports], and 2004. It provides clinical trial services only to clinical “I have never before seen the winning will require a combination EU legislation specifically trials that commit to be registered, to publish results mighty drug industry lose a of legislation and demands from mandates their disclosure— irrespective of findings, and to make their raw data public battle so completely as patients and the public for greater and all of this in less than five available to other researchers after the completion of during [that] afternoon.” transparency.” years.”8‑12 the trial. 16 3 January 2015 | the bmj CLINICAL TRIALS Laparoscopic colorectal surgery The role of eating fish in stroke prevention PLUS Managing tennis elbow Maintaining weight loss in adults Why WHO’s future hangs in the balance Insoles for medial knee osteoarthritis In search of beneficial drug reactions Management of chronic rhinosinusitis Supplements to prevent pre-eclampsia Gambling addiction: a patient’s journey Diagnosing active and latent tuberculosis Easily missed: giant cell arteritis 344:1-52 No 7838 ISSN 1759-2151 345:1-52 No 7881 ISSN 1759-2151 342:1159-1216 No 7808 ISSN 1759-2151 7 January 2012 | bmj.com 3 November 2012 | bmj.com 28 May 2011 | bmj.com To mark the first major breakthrough in this long battle, in this article The BMJ would like to highlight MISSING TRIAL DATA Why we need the full picture and thank the leading campaigners and policy makers in the United Kingdom and across Europe who have taken risks and persevered to help shape a new era of transparency. Of course, many other organisations have The struggle for access to thrown their weight behind this campaign and helped unpublished trial data to increase the pressure: the French drugs journal Pre- scrire, Transparency International, the International But many battles m eaning that the full trial data on the vast majority of the Society of Drug Bulletins and Berlin Declaration 2012 are still to be drugs we currently use will still not be available. (http://chn.ge/13HlGYl), to name but a few. And drug fought. For now, However, the fact is that within two years the public companies would not of course have felt the full pres- the European and researchers will be able to read, in full, clinical study sure of the need for transparency without the tireless Medicines Agency reports for all newly approved drug trials, whether con- efforts of tenacious lawyers who exposed some egre- can still make ducted by industry or academia. gious cases of malpractice through the courts. The BMJ “It’s easy to focus on the hurdles ahead, but let’s stop has also supported AllTrials (alltrials.net), the cam- restrictions and and appreciate just how far we’ve already come and how paign for full disclosure of trial data, and will continue redactions if it quickly,” said The BMJ’s deputy editor Trish Groves, who is to do so. considers data to responsible for all original research published in The BMJ. Ben Adams freelance journalist, London be confidentially “Suddenly, everyone who used to think it was fine to hide [email protected] commercial data from clinical trials has realised that it’s not OK.” Cite this as: BMJ 2015;350:g7717 THE PEOPLE WHO PUSHED FOR CHANGE BEN GOLDACRE PETER DOSHI DOUGLAS ALTMAN KAY DICKERSIN AND The psychiatrist, academic, and author of Peter Doshi, assistant professor at the The founder and director of the Centre TOM GREENE two bestselling books about the misuse Department of Pharmaceutical Health for Statistics in Medicine and Cancer Kay Dickersin, professor at of science to mislead the public, Bad Services Research at the University Research UK’s Medical Statistics Group, the Johns Hopkins Bloomberg Science (2009) and Bad Pharma (2012), of Maryland’s School of Pharmacy in Douglas Altman, has worked to ensure that School of Public Health, Ben Goldacre has used his anger, humour, Baltimore and an associate editor at the methods and results of clinical and Baltimore, and director of scientific rigour, and ability to write to The BMJ, leads the Restoring Invisible epidemiological studies are of high quality the Center for Clinical Trials force the issue that has long festered and Abandoned Trials (RIAT) initiative. and, most importantly, are reported fully and the US attorney Tom within the medical community on to the In 2013 Doshi and his university and honestly.13 Greene started digging for public agenda. He argued, in Bad Pharma, colleagues called for trial sponsors and He is behind the development of many the missing data on Pfizer’s that “the whole edifice of medicine is investigators of abandoned studies to research reporting guidelines, such as pain drug gabapentin broken,” because the evidence on which publish (or republish) their data and the CONSORT (Consolidated Standards (Neurontin).
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