Article first published online: 2 AUG 2012
© 2012 The Author, Addiction © 2012 Society for the Study of Addiction
Volume 107, Issue 9, page 1544, September 2012
How to Cite
West, R. (2012), Trial protocols. Addiction, 107: 1544. doi: 10.1111/j.1360-0443.2012.03989.x
- Issue published online: 2 AUG 2012
- Article first published online: 2 AUG 2012
Addiction will now consider submissions of trial protocols. It has long been recognised that major trials evaluating the effectiveness of interventions should be registered in advance and their protocols and analysis plans made publicly available ahead of the analysis and reporting of the findings. There are several reasons for this. One is so that other researchers can see what studies are being done so as to avoid duplication or improve coordination of effort. Another is to minimise the ‘file drawer effect’ leading to overestimation of effect sizes. A third is to disseminate good ideas with regard to trial design in a timely manner.
There are a number of journals that publish trial protocols, some of them open access. Making these protocols open access should help with the mission of wide dissemination. However, the price of open access material is relatively high and for productive research teams it can represent a significant drain on resources that could be used for conducting research. Addiction has decided that it will therefore, for the first 12 months after publication of research protocols, provide the articles as free content. Readers of the journal will be aware that we already provide all of our commissioned material free, as well as a selection of other articles. This arises from a philosophy of trying to make the fruits of science as widely available as possible within the publishing model currently operating.
We will only have space for up to half a dozen protocols in the first year. We will review the policy after this. This means that we will have to be highly selective about the protocols that we publish. These should relate to major clinical evaluations of interventions aimed to combat addiction. These do not have to be the classical randomised controlled trial. They can be cluster randomised trials, stepped wedge designs or indeed any design which is intended to provide the nearest thing possible to a definitive answer to the question of whether an intervention is more effective than a comparator and if so by how much. Pilot trials and proof of concept studies will not be considered. This means that the trials will have to have adequate control for potential confounding factors, adequate sample sizes and use accepted measures of outcome that are of clinical significance. The primary outcome variable and analysis plan needs to be spelled out and the expected timeline for completion and reporting specified.
There should be a commitment to submitting the findings for publication regardless of the outcome. It will also be expected that there will be a plan for reporting analyses that can indicate whether the putative mechanism of action of the intervention plausibly mediated the outcomes. Finally, we will only consider protocols relating to interventions in which there is a commitment to public sharing of the intervention content in full so that others may learn from the findings.
The abstract should have headings of: Background and aims, Methods, and Discussion. The report itself should follow CONSORT headings (www.consort-statement.org), including Rationale and literature review, Design, Participants, Sample size and power calculations, Setting(s), Intervention and comparison conditions (for behavioural interventions the full manual should be made available as supplementary material or reference made to a publicly available source), Primary outcome variable and how it will be measured, Secondary outcomes variables and how they will be measured, Baseline measures and how they will be used, Process measures and how they will be used, Analysis plan, Interim analysis and stopping plans if relevant, and Blinding.
Declaration of interests
RW has received travel funds and hospitality from, and undertaken research and consultancy for pharmaceutical companies that manufacture or research products aimed at helping smokers to stop. These products include nicotine replacement therapies and Zyban (bupropion). This has led to payments to him personally and to his institution. He undertakes lectures and training in smoking cessation methods which have led to payments to him personally and to his institution. He has received research grants from medical charities and government departments.
Editor-in-Chief, Addiction, Health Behaviour Research Centre, Department of Epidemiology and Public Health, University College London. London, UK. Email: firstname.lastname@example.org