Campaign group AllTrials has published a framework for good reporting practice for clinical trials and is welcoming comment on its proposals.
“This document sets out more information about achieving a situation globally where all trials are registered and results reported,” said the group in a statement.
AllTrials was set up in January by the British Medical Journal (BMJ), the James Lind Initiative, the Centre for Evidence-Based Medicine, Sense About Science and Bad Pharma author Ben Goldacre to tackle the lack of access to clinical trial data. It is calling for full reporting of all clinical trials, including all results and trial methods.
Opponents of full transparency – including Pharmaceutical Research and Manufacturers of America (PhRMA) John Castellani – argue that mandatory disclosure could affect patient privacy, stifle new drug discovery, and make sensitive information available to unscrupulous parties.
The manifesto sets out four levels of information in clinical trial reporting. Firstly, it asks for a clinical trials register, so that there is a record of all trials being conducted. In addition, there should be a brief summary of a trial’s results, alongside full details about the trial’s methods and results.
The fourth level – which AllTrials says should not be made publicly available – is individual patient data, although the group notes that initiatives are underway in many countries looking at how information on patient-level data could be safely shared between researchers.
The publication of the manifesto comes at a time when the reputation of the pharma industry has been hit by allegations that it planned to use patient groups to lobby against a drive towards transparency announced by the European Commission.
In response, the PhRMA and European Federation of Pharmaceutical Industries and Associations (EFPIA) published last month a commitment to sharing anonymised trial data with qualified researchers.
At the time, EFPIA director general Richard Bergström called its approach “a responsible alternative to other proposals being put forth in the EU”, such as the European Medicines Agency (EMA) plan to release clinical trial data on all newly-approved pharmaceutical drugs.
Meanwhile, Castellani provided testimony to Congress last month that highlighted the EU’s transparency plan as a concern in light of the proposed Transatlantic Trade and Investment Partnership (TTIP), which is currently being negotiated.
“The EMA’s current and proposed data disclosure policies … risk damaging public health and patient welfare,” he said.
Regardless of one’s point of view, AllTrials is acting as a catalyst on transparency, and the new document is sure to generate feedback that will inform the debate.
The group is backed by some real heavyweights – including the Wellcome Trust and the National Institute for Health and Care Excellence (NICE) – and most recently added the British Science Association (BSA) to its list of supporters.
“The AllTrials campaign aims to draw attention to the fact that clinical trials that fail to detect any benefit are reported far less often than those which do,” said the BSA, which promotes and support science and engineering in the UK.
This selectivity leaves us “with a skewed image of how well many medical treatments work,” it added.