Happy International Clinical Trials Day!
Since today (20 May) is the third annual international clinical trials day it seemed the perfect occasion to share some trials news with PLoS Medicine readers.
Many of you will know that new FDA legislation in the United States will require, from September 2008, public reporting of basic trial results within one year of study completion. Many organisations and institutions will now be thinking about how to comply with the new requirements. Some groups are coming together to discuss how to standardise and implement results disclosure — as they did for trial registration with the Ottawa Statements and the WHO International Standards of Trial Registration.
We recently participated in an initiative called PROCTOR (Public Reporting Of Clinical Trial Outcome and Results), organised by the Canadian Institutes of Health Research (CIHR) and bringing together stakeholders from the worlds of research, journals, industry, consumer groups, and policy. The idea was that while many parties are calling for the public reporting and accessibility of clinical trial results, there’s as yet no consensus about how this might be achieved.
Over two days in late March in beautiful Ottawa (as the Canada based editor at PLoS, I live down the road in Toronto), the discussions centred on the importance and opportunities to improve the transparency, completeness, and usability of trial results—partly by using new technologies, and also by developing universal standards. The group also identified many challenges to implementing a fair and trusted global system, and agreed that the meeting was only the beginning of an international dialogue with many other stakeholders and organisations.
Of real interest to us journals and one of the concerns from researchers and the industry was the impact that results disclosure might have on subsequent publication. At PLoS we support the public disclosure and open access publication of all clinical trial results and feel that more disclosure can only be good; hence our policy, revised recently in the light of these initiatives, is that “prior disclosure of results on a public website such as clinicaltrials.gov will not affect the decision to peer review or acceptance of papers in PLoS journals.”
This is in keeping with our general policy that “Authors are of course at liberty to present and discuss their findings ahead of publication: at medical or scientific conferences, on preprint servers, in public databases, and in blogs, wiki and other informal communication channels.”
The PROCTOR group has recently proposed to the WHO that a broader international dialogue be initiated. And indeed the WHO has recently announced its consultations on clinical trials results reporting, which we’re all invited to contribute to starting today and running until 27 June 2008.
I’m attending the Council of Science Editors meetings this week in Vancouver (www.councilscienceeditors.org), and in today’s session on clinical trial registration it was brought to my attention that the Croatian Medical Journal has published a news item on the PROCTOR initiative:
I was wondering what PLoS thought with regard to the FDA rejecting the Declaration of Helsinki. Will PLoS be changing its ethical demands accordingly or will it continue to conform with this requirement? I was curious after reading this article in Nature.