We have a chance to get the most influential health body in the world – the World Health Organisation (WHO) – to say something strong on the need for the results of all clinical trials to be publicly reported. Following all of our pressure, the WHO has decided it needs to say something about this and is seeking comments on its draft policy. We have to grab this fantastic opportunity with both hands.
Today, 80,857 individuals and 518 organisations support the AllTrials campaign. We all have to tell the WHO that its statement is a very welcome opportunity to set a strong global standard for clinical trial reporting. If there is only one thing you do after signing the AllTrials petition, please make it this.
Write to the WHO to tell them they must take this opportunity by:
- Calling for the results of all past clinical trials to be reported, as well as all future clinical trials.
- Requiring results to be reported within 12 months, rather than permitting delays of 18-30 months. The USA’s FDA Amendment Act, the newly adopted EU Clinical Trials Regulation and pharmaceutical companies including GSK and LEO Pharma all agree that 12 months is enough time to report results.
- Encouraging researchers to put results on publicly accessible registers, in useful, standardised formats.
Email your comments to firstname.lastname@example.org before Saturday, 15 November 2014. Please remember to include your name and contact details as the WHO will not consider anonymous comments.
Read the full AllTrials response to the consultation below. Feel free to add any of our words to your own comment.
We know the WHO is going to face resistance from some sectors who say the draft statement goes too far. We can’t let the WHO only hear from those opposed to greater transparency.
Please write to them today.
WHO Statement on Public Disclosure of Clinical Trial Results
Response on behalf of AllTrials campaign
We welcome the WHO’s decision to adopt a statement on clinical trial reporting. This decision will also be welcomed by doctors, patients and researchers around the world. It reflects the Declaration of Helsinki which states that “every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject” and that “researchers have a duty to make publicly available the results of their research.”
This memo is on behalf of the 80,000 individuals and 520 organisations that have joined the AllTrials campaign for all clinical trials to be registered and results reported. Many supporters of the AllTrials campaign will also be submitting their own responses. We would welcome the opportunity to discuss any of these points further.
The Statement needs to call for the disclosure of the results of past trials on the treatments we use today. The vast majority of medicines we use every day were approved by regulators a decade or more ago and so were tested in clinical trials over the past decades. As an example, this includes all of the drugs that are currently on the WHO essential medicines list and the Package of Essential Noncommunicable (PEN) Disease Interventions for Primary Health Care in Low Resource settings. It is these past trials that have not fully been reported: extensive documentation will still exist, and it should be shared. The best available evidence  is that around half of all clinical trials have not reported results. Doctors, patients and funders of health services cannot make informed decisions about which treatment is best, if half of all the trial results on that treatment are withheld. The WHO has the opportunity to state unequivocally that the era of secrecy must end and that there is a moral imperative to report the results of all trials that have occurred, on all treatments currently being used.
However, we recognise that standards for planning, conducting, and reporting trials have changed a lot over the past decade. So have standards and formats for collecting, analysing, curating, and storing data. Moreover, research teams may have split up and moved on, leaving results in various different places. For all these reasons it may not be easy to disclose old results, and datasets may not always be complete or in great shape. So the WHO should not seek perfection and should instead make it clear that getting old results into the public domain, “warts and all”, is far better than allowing them to stay hidden.
The WHO should adopt the globally accepted timeline of 12 months to report results. A deadline of 12 months to report results or to offer a public reason for any delay has been accepted by legislators, regulators and pharmaceutical companies. Both the USA’s FDA Amendment Act 2007 and the newly adopted EU Clinical Trials Regulation require results to be reported within 12 months of the completion of the clinical trial. Pharmaceutical company GlaxoSmithKline’s approach is to publish summary results from pharmaceutical clinical trials within 8 – 12 months of completion of the study . Pharmaceutical company LEO Pharma publishes summary results of all its clinical trials within 12 months of the completion of the study .
We recognise that publication in peer reviewed journals can take time; however, results can be reported on clinical trial registers sooner. After results are reported in these registers, researchers can aim to publish in academic journals (even if that may take longer than 12 months). Publication of results in a clinical trial register does not prejudice subsequent publication of a peer reviewed paper based on the results, for example the International Committee of Medical Journal Editors 2013 statement: “The ICMJE does not consider results posted in clinical trial registries as previous publication if the results are presented in the same, ICMJE-accepted registry in which initial registration of trial methods occurred and if the results are posted in the form of brief structured abstracts or tables.” 
Publication of results on a register should be preferred. The WHO statement suggests that results should be reported both in a peer reviewed journal paper and on a publicly available register. We consider mandating publication in a peer reviewed journal within 18 months to be inappropriate and unworkable. Furthermore, while academic journals do not always provide complete and objective reporting of results (permitting, for example, primary outcomes to be switched and substituted) registers offer more standardised and objective formats than journal publications. A 2013 review in PLOS Medicine of results of the same trial published on ClinicalTrials.gov and in a journal paper found that “trial results, especially serious adverse events, are more completely reported at ClinicalTrials.gov than in the published article.”  The researchers found that the summary results contained more efficacy results than the published article (79% vs. 69%), adverse events (73% vs. 45%), serious adverse events (99% vs. 63%) and the flow of participants (64% vs. 48%). Standardised reporting on registers is the only way to ensure that vital important information about outcomes measured and adverse events are made available. In addition, peer reviewed publication is not always within a researcher’s control, certainly the timing of publication would not be.
We urge the WHO to suggest that publication of standardised results on a clinical trial register be mandatory, with subsequent publication of a journal paper or papers desirable but not mandatory.
Further measures are needed to improve clinical trial results reporting.
We urge the WHO to take this opportunity to explore further measures to support and improve reporting of clinical trial information.
The WHO should build on the establishment of the ICTRP and call for all clinical trial registers to accept results for all trials on the register in a standardised format.
The WHO should also require that registries provide study protocols (with version number and any amendments clearly reported) or, at least, linkage to protocols elsewhere on the web.
The WHO should recommend that protocols for clinical trials are written in accordance with the SPIRIT reporting statement. 
The WHO should require that all registers give structured data on the date on which results are required, and when results have been posted, and where; with documentation of the correspondence explaining why the results have been withheld, wherever there are delays.
The WHO should encourage trial funders to routinely audit publication records, to identify where results are missing on specific trials, and explain where and why a delay has been granted.
The WHO should encourage journals to check registration and reporting of trial results of trials submitted to them for publication.
The WHO should encourage ethics committees and ethical review boards to review publication of results from trials approved by them, and request new applicants to disclose whether they or their sponsor are currently withholding results on any previous trials more than 12 months after completion.
Since methodological shortcomings in trials are often only apparent in the Clinical Study Report on a trial, the WHO should advise sponsors and regulators to disclose these documents publicly, with appropriate controls to protect patient confidentiality where necessary, within 12 months of trial completion, wherever such a CSR has already been produced.
 F Song, S Parekh, L Hooper, YK Loke, J Ryder, AJ Sutton, C Hing, CS Kwok, C Pang, I Harvey. Dissemination and publication of research findings: an updated review of related biases. Health Technology Assessment 2010; Vol. 14: No. 8 http://www.journalslibrary.nihr.ac.uk/__data/assets/pdf_file/0005/64751/FullReport-hta14080.pdf
 GSK – Public Disclosure of Clinical Research http://www.gsk.com/media/280827/disclosure-of-clinical-trial-information-policy.pdf
 LEO Pharma’s Position on Public Access to Clinical Trials Information http://www.leo-pharma.com/Home/Research-and-Development/Clinical-trial-disclosure/LEO-Pharmas-position-on-transparency.aspx
 ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholary Work in Medical Journals http://www.icmje.org/icmje-recommendations.pdf
 C Riveros, A Dechartres, E Perrodeau, R Haneef, I Boutron, P Ravaud. Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals. PLOS Medicine. 2013 Dec 8. DOI: 10.1371/journal.pmed.1001566. http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001566
 SPIRIT 2013 Statement: Defining standard protocol items for clinical trials http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/