AllTrials campaign and petition support greater clinical trial transparency
Elsevier supports the growing movement to require clinical trials to be registered and their results reported
By Síle Lane Posted on 23 June 2014
The AllTrials campaign, launched in January 2013, calls for all clinical trials to be registered and their results reported. The initial group of six organizations has since been joined by 79,000 people and nearly 500 other groups worldwide, including medical associations, research funders, medicines regulators, pharmaceutical companies, consumer associations, publishers and more than 200 patient groups.
Members of the campaign want all clinical trials, past and present, to be registered, full methods and summary results to be publicly available, and Clinical Study Reports (large documents needed for marketing authorization processes) to be available where they have been produced. They have started serious discussions about what the aims mean for their sectors.
What is the AllTrials campaign?
The AllTrials campaign calls for all past and present clinical trials to be registered and their results reported. The campaign has published a detailed plan on how this could be done. You can download the PDF or read it online.
The AllTrials campaign is an initiative of Bad Science, BMJ, Centre for Evidence-based Medicine , Cochrane Collaboration, James Lind Initiative, PLOS and Sense About Science and is being led in the US by Dartmouth's Geisel School of Medicine and the Dartmouth Institute for Health Policy & Clinical Practice. The AllTrials campaigns relies on donations. Find more information and the campaign petition at www.alltrials.net.
AllTrials discussion at EOSF
The AllTrials campaign is holding a discussion session at the European Open Science Forum in Copenhagen today, June 23, on the practical measures that researchers, regulators, publishers and doctors must put in place to fulfill their commitments.
We are working with professional bodies to deem it professional misconduct to fail to register trials and report results. We are urging ethical approval bodies to monitor reporting and refuse consent where previous trial lists haven't reported. We are working with registries to make more past trial registration possible. And we are encouraging the media to cover the groundswell of support to rectify this gross abuse of patient trust.
Patients volunteer for clinical trials on the understanding that what was found out in the trial will be added to the body of medical knowledge about their condition and will benefit patients like them in the future. But about half of all clinical trials have never published results, so the findings generated by the participation of hundreds of thousands of patients remain hidden and unused. This is a betrayal of their trust.
In addition, withholding results means people who make decisions about medicines – doctors, regulators and insurance payers – don't have access to all the information they need.
Hundreds of AllTrials members wrote to their Members of the European Parliament (MEPs) and health ministers during debates on the European Union (EU) Clinical Trials Regulation. In April, the European Parliament passed a law that would require all clinical trials to be registered and report results in Europe starting in 2016. MEPs have told us that letters from individual supporters gave them the arguments to make in debates on the legislation.
Canada just passed a law that says that clinical trial information should be made public, after hundreds of campaign supporters wrote to Members of Parliament there.
Companies are joining, too, including GSK, which built an online system to allow researchers access to clinical trial information, and Johnson and Johnson, which handed all their clinical trial data to researchers at Yale University's Open Data Access Project for independent scrutiny.
A year ago, the European Medicines Agency (EMA) announced a new policy to be more transparent and to proactively publish Clinical Study Report. The EMA has now opened the policy up to public consultation and received more than 1,200 responses – the most they had ever received. The EMA hit a barrier when two pharmaceutical companies launched court cases against it to keep clinical trial information hidden and announced its intent to roll back its plans on transparency. Hundreds of letters from AllTrials supporters to the EMA Management Board succeeded in changing their minds at the last minute, and the EMA has agreed to take away some of the barriers to transparency.
Elsevier supports clinical trial transparency
By Ylann Schemm
Elsevier has pledged to support the further development of the AllTrials campaign to drive greater clinical transparency. We envision this as both a strategic advisory role on how publishers can contribute, and a technical and operational one exploring how we can embed clinical trial registration in our peer review processes, in ScienceDirect and Scopus through the use of unique identifiers to track research on specific trials, in new rules for authors, and in collaborating with fellow publishers to develop new industry standards.
Tracey Brown, Managing Director of Sense About Science, one of the founding organizations of the AllTrials campaign:
As a large publisher in medicine, Elsevier's support for the aim of openness about clinical trials – and its commitment to working out journal policies that help achieve that – takes us a significant step closer towards ending the era of secrecy and sloppiness in clinical trials reporting.
Anne Kitson, Executive VP of Health & Medical Sciences at Elsevier:
Elsevier is proud to support the AllTrials campaign. As a leading STM publisher producing a quarter of the world's medical and scientific literature, we believe that we can bring a unique scope and scale to boosting clinical trial transparency. It's a responsibility we take seriously.
Catriona Fennell, Director of Journal Services, is responsible for Elsevier's publishing ethics initiatives including CrossCheck, the development of ethics education programs, and serving as Elsevier's liaison with the Committee on Publication Ethics (COPE).
We are looking forward to working closely with Sense About Science and the AllTrials community to contribute to this important campaign. Embedding clinical trials transparency into our editorial, production and publication platforms will take time, but we are excited to explore how we can develop best practice and further the critical aims of All Trials.
Dr. Stephane Berghmans is VP of Global Academic Relations EU for Elsevier. In his previous position as Head of the Biomedical Research Unit at the European Science Foundation, he coordinated a foresight report on the "Implementation of Medical Research in Clinical Practice" that recommended promoting rigorous registration of clinical studies and reporting of these results.
I am very pleased to see Elsevier committing to this important recommendation in line with an unbiased reporting of clinical research supported by the AllTrials campaign.
Video: "AllTrials: Make clinical trials count"
Elsevier Connect Contributors
Síle Lane is Director of Campaigns for Sense About Science, a UK nonprofit organization that helps the public make sense of science and evidenceby providing information, countering misinformation and championing research and high quality evidence. Lane oversees Sense About Science's campaigns work, which includes the libel reform campaign that led to the Defamation Act 2013, the Ask for Evidence campaign, which encourages people to ask for evidence for every claim they see, and the AllTrials campaign for clinical trial transparency. Read her articles here.
As Senior Corporate Responsibility Manager for Elsevier, Ylann Schemm (@ylannschemm) heads programs that focus on sound science, advancing women in science and developing research access in the developing world. She serves as the Program Director of the Elsevier Foundation's New Scholars program, which supports projects to expand the participation of women in STEM, and the Innovative Libraries in Developing Countries program, which supports capacity-building projects in science, technology and medicine.