So, this has been fairly well-reported already. But in a show of my utmost commitment to the transparency agenda here is a link to the news release on the Royal College of Physicians (RCP website) about yesterday’s launch by the Ethical Standards in Health and Life Sciences Group (ESHLSG) (a consortia of professional, medical and commercial organisations) of: Clinical Trial Transparency Principles and Facts.
The first step towards transparency would have been for RCP to have published the thing on their website alongside the news release (big sigh). But at least they are well-ahead of the ABPI which hasn’t even got a mention of it on their site as far as I can see.
Such is life. Here are the principles enshrined in the document for everyone’s consumption:
• Investigators should ensure that the methods and plans for their clinical study or trial are recorded on a publicly accessible register within 21 days of initiation of patient enrolment, and that this information is kept up to date.
• With commercial pharmaceutical trials, investigators should make available the methods and results of the trial within one year of the product gaining marketing authorisation and being available on the market in any country worldwide.
• Where a product fails to secure to marketing authorisation but the trial results are “of significant medical importance”, they should be made available within one year of the trial being completed, through a publicly accessible website or journal.
• For all other studies or trials, investigators should make available the methods and results within one year of completion through a publicly accessible website or journal.
• Investigators should report the trial “fully and transparently”, following appropriate reporting guidelines, and in particular the recommendation in the current version of the CONSORT (Consolidated Standards of Reporting Trials) statement.
• Investigators should ensure that no “important aspect” of trial results has been omitted, and that any deviations from the study protocol are explained.
• Investigators should ensure that any interpretation of their clinical trial accurately reflects the research questions, study design and results, and is without bias.
• Investigators should report their clinical trial in enough detail to allow other researchers to extract the trial design and data for use in meta-analyses and systematic reviews.
• Investigators listed as authors on publications arising from clinical trials are responsible for all of the content and should ensure that they adhere to the ICMJE (International Committee of Medical Journal Editors) guidelines in terms of qualifying for authorship.
Great online debate about public engagement today, hosted by The Guardian. You can see the feed here. Still digesting and might reflect publicly in due course.