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ResourcesHuman Research EthicsTime to publication for publicly funded clinical trials in Australia: an observational study (Papers: Linn Beate Strand, et al | 2017)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Time to publication for publicly funded clinical trials in Australia: an observational study (Papers: Linn Beate Strand, et al | 2017)

Published/Released on March 01, 2017 | Posted by Admin on April 16, 2017 / , , , , , , , ,
 


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Abstract

Objective
To examine the length of time between receiving funding and publishing the protocol and main paper for randomised controlled trials.

Design
An observational study using survival analysis.

Setting
Publicly funded health and medical research in Australia.

Participants
Randomised controlled trials funded by the National Health and Medical Research Council of Australia between 2008 and 2010.

Main outcome measures
Time from funding to the protocol paper and main results paper. Multiple variable survival models examining whether study characteristics predicted publication times.

Results
We found 77 studies with a total funding of $A59 million. The median time to publication of the protocol paper was 6.4 years after funding (95% CI 4.1 to 8.1). The proportion with a published protocol paper 8 years after funding was 0.61 (95% CI 0.48 to 0.74). The median time to publication of the main results paper was 7.1 years after funding (95% CI 6.3 to 7.6). The proportion with a published main results paper 8 years after funding was 0.72 (95% CI 0.56 to 0.87). The HRs for how study characteristics might influence timing were generally close to one with narrow CIs, the notable exception was that a longer study length lengthened the time to the main paper (HR=0.62 per extra study year, 95% CI 0.43 to 0.89).

Conclusions
Despite the widespread registration of clinical trials, there remain serious concerns of trial results not being published or being published with a long delay. We have found that these same concerns apply to protocol papers, which should be publishable soon after funding. Funding agencies could set a target of publishing the protocol paper within 18 months of funding.

Strand LB, Clarke P, Graves N, et al Time to publication for publicly funded clinical trials in Australia: an observational study. BMJ Open 2017;7:e012212. doi: 10.1136/bmjopen-2016-012212
Publisher (open access): http://bmjopen.bmj.com/content/7/3/e012212.info

With publically funded research there is not an unreasonable expectation that there should be a public good from the funded research. The reported outcome of a clinical trial is one way in which the public benefits. The delays reported by this paper does beg five questions: (i) what are the reasons (if any) for the delay; (ii) should the research office where the chief investigator is based monitor and chase to ensure the outcome is published; (iii) is the lack of, or delayed, outputs an ethical issue; (iv) do funding bodies have a role to play here; (v) Given the often high price of journal subscriptions should the outcomes of publically funded research be made widely available using open access publications?



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