The “Guidelines for Authors and Translators of Scientific Articles to be Published in English” developed by the European Association of Science Editors (EASE) have been updated in December 2015.

Visit our resources developed by editorial groups.

The updated Good Publication Practice guideline (GPP3, replacing GPP2) has been published by the Annals of Internal Medicine.
The guideline focuses on the publication of company-sponsored medical research; however, the principles of GPP3 apply to all research and will be useful for all medical and health care professionals involved in research publication.

Full details for GPP3 and links to previous versions of the guideline are available here.

Kaplan and Irwin analysed all large NHLBI supported RCTs between 1970 and 2012 evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease. Trials were included if direct costs >$500,000/year, participants were adult humans, and the primary outcome was cardiovascular risk, disease or death. The 55 trials meeting these criteria were coded for whether they were published prior to or after the year 2000, whether they registered in clinicaltrials.gov prior to publication, used active or placebo comparator, and whether or not the trial had industry co-sponsorship. We tabulated whether the study reported a positive, negative, or null result on the primary outcome variable and for total mortality.

The analysis of 55 trials meeting the inclusion criteria showed that 17 of 30 studies (57%) published prior to 2000 showed a significant benefit of intervention on the primary outcome in comparison to only 2 among the 25 (8%) trials published after 2000 (χ²=12.2,df= 1, p=0.0005).

The authors also looked into various aspects of transparent reporting: improvement in time in including diagrams reporting patient flow throughout the study, registration of studies on ClinicalTrials.gov and a prospective declaration of the primary outcome (see the last 3 paragraphs of the Results).

The authors note various important initiatives improving transparency of RCTs – including major journals requiring trial registration and following the CONSORT recommendation when reporting trial methods and findings. They state: “All of their (NHLBI) large trials published after 2000 were preregistered and transparently reported. Although we cannot say that stricter reporting requirements caused the trend toward more null reports from NHLBI trials, we do find the association worthy of more investigation.”

And implications for us: “A growing collection of trials suggests that promising treatments do not match their potential when systematically tested and transparently reported. Publication of these trials may lead to the protection of patients from treatments that use resources while not enhancing patient outcomes. For example, a recent economic analysis of the Women’s Health Initiative clinical trial suggested that the publication of the study may have resulted in 126,000 fewer breast cancer deaths, and 76,000 deaths from heart disease between 2003 and 2012. The economic analysis estimated that there was about $140 returned for each dollar invested in the study. Transparent and impartial reporting of clinical trial results will ultimately identify the treatments most likely to maximize benefit and reduce harm.”

Reference:

Kaplan RM, Irvin VL. Likelihood of null effects of large NHLBI clinical trials has increased over time. PLoS One 2015; http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0132382

In his recent editorial for the BMJ John Ioannidis writes:

“Trials should be properly randomized (currently more than half are not randomized at all) and use optimal study designs. They should ask key questions that matter to patients and the public, and they should be informed by a systematic examination of previous evidence. Trials should be well powered and use the best comparators, with pre-registration of their design and outcomes, and, whenever possible, of the analysis plan. They should avoid overt conflicts in their funding. They should be designed and conducted by non-conflicted trialists. Their results and their raw data should be publicly available and transparent. Eventually, randomized controlled trials could be the pride of clinical investigators who collaborate in research that matters, and the best source of information on how to improve health. This is what trials were supposed to be, even if we have almost totally forgotten this over the years.”

JPA Ioannidis. Clinical trials: what a waste. BMJ 2014;349:g7089. doi: http://dx.doi.org/10.1136/bmj.g7089 (Published 10 December 2014)

A new Trials editorial by Douglas G Altman, Curt D Furberg, Jeremy M Grimshaw and Daniel R Shanahan

Abstract:

The medical literature is vast and it is impossible to keep up with the deluge of new research articles. With ongoing concerns regarding manipulation of the outcomes and analyses reported in medical research, it is increasingly important that researchers are able to easily identify and access all publications relating to a specific clinical trial, in order to get the complete picture and to reliably evaluate bias or selective reporting. Recent developments and innovations within the threaded publications initiative and the Linked Reports of Clinical Trials project demonstrate progress towards the ideal of making all trial information readily available.

Full text: http://www.trialsjournal.com/content/15/1/369/abstract

A nice overview of the COMET initiative’s work and the group’s latest research.

Professor Doug Altman, director of the EQUATOR programme, is also a member of COMET’s management group.

Reference:

Nature Medicine 20, 798–799, (2014), doi:10.1038/nm0814-798

The STRATOS (STRengthening Analytical Thinking for Observational Studies) initiative has been set up to develop accessible and accurate guidance in the design and analysis of observational studies.

The STRATOS website (http://www.stratos-initiative.org/) has been launched recently. The website provides more details about the group and its plans.

Publications:

Sauerbrei W., Abrahamowicz M., Altman D. G., Cessie S., Carpenter J., on behalf of the STRATOS initiative (2014), STRengthening Analytical Thinking for Observational Studies: the STRATOS initiative, Statist. Med., doi: 10.1002/sim.6265

An editorial published in PLoS Medicine introduces new measure to further support transparency and usability of published research. PLoS editors are strengthening their reporting requirements for observational and diagnostic accuracy studies (requiring the use of STROBE and STARD reporting guidelines when preparing research manuscripts). Further changes in editorial policies relate to extending journals’ data sharing policies and protocol availability to observational studies.

This move should undoubtedly provide inspiration to other journal editors (see the EQUATOR toolkit for editors for more resources, guidance, examples and editorials from other journals, etc.)

Reference:

The PLOS Medicine Editors (2014) Observational Studies: Getting Clear about Transparency. PLoS Med 11(8): e1001711. doi:10.1371/journal.pmed.1001711

The Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations was developed as part of the 3rd World Conference on Research Integrity, 5 – 8 May 2013, in Montréal, as a global guide to the responsible conduct of research.

The full text of the statement (in English and Spanish) is available at the research integrity conferences website.

The next conference on research integrity will take place next year in Rio de Janeiro (http://www.wcri2015.org/)