“The Publication Plan” is now also launched on Facebook


“The Publication Plan” has launched its official Facebook page, as a new platform to share news and information with authors, researchers, medical writers and communications professionals, pharmaceutical industry managers, medical journal editors and publishers (amongst others).


MPIP issue new recommendations to complement existing harms reporting guidelines

Transparent and clinically relevant reporting of adverse event data has been identified as a significant unmet need in industry-sponsored publications. Although guidelines such as the CONSORT Harms Extension have improved reporting, poor adherence and a lack of specificity has seen suboptimal implementation of these recommendations. To this end, Medical Publishing Insights & Practices (MPIP) has held in-depth interviews with industry experts, journal editors and clinical investigators to assess current policies and best practices for harms reporting in clinical trial publications, with the aim to identify and address gaps in current guidelines. Based on a consensus process, MPIP has developed five recommendations intended to supplement existing guidance:

  1. Identify and communicate the most clinically relevant drug adverse event data as part of a comprehensive safety profile.
  2. Report timing, frequency, duration, and other potentially relevant descriptors when clinically appropriate.
  3. Use statistical analysis for clinically relevant adverse events (where appropriate).
  4. Avoid use of overly general text descriptions for adverse events, including in abstracts.
  5. Discuss adverse events findings in the broader context of available evidence and maintain consistency of data across different public reports.

The authors discuss how they aim to disseminate and encourage adoption of these recommendations, starting with implementation by MPIP members within their own research divisions. The authors will also encourage the adoption of the guidelines by non-industry groups given the common goal of improving the transparency and credibility of adverse event reporting in published manuscripts.


Summary by Alice Wareham, PhD from Aspire Scientific

eLife to start charging publishing fees from 2017

The open-access journal eLife is to start charging publishing fees from 2017. Expenses have been covered to date by three of the largest private research funding organisations (Howard Hughes Medical Institute, Wellcome Trust, Max Planck Society). These organisations will continue to subsidise publishing costs, with authors expected to provide $2500 of the $3085 cost associated with publishing each article.

Unusually, eLife have published details of how they decided on the $2500 publishing fee. These show that the publishing fee covers marginal costs (costs that increase with each new submission, including editor salaries and payments for 3rd party article processing systems) with a small contribution towards fixed costs. Journals that are highly selective – eLife rejected nearly 85% of articles submitted last year – tend to have higher operating costs than less selective journals. eLife’s 2017 publishing fees are in the range charged by other open-access journals, with some top tier journals charging over $5000 per article.



Summary by Philippa Flemming, PhD from Aspire Scientific.

Does the ‘Open Access Citation Advantage’ exist?


As open access (OA) articles are freely available, the potential readership and impact is much greater than for articles where access to the full-text is limited to subscribers only. But does increasing the visibility of research result in more citations?

Studies suggesting that this Open Access Citation Advantage (OACA) exists have been challenged due to a number of unaddressed confounding factors, such as self-selection bias, where authors may preferentially choose higher-quality articles for OA. Furthermore, existing papers addressing the OACA have focused on specific disciplines, used small sample sizes or assessed articles that may not have been OA long enough to show a significant effect on citation rate.

Jim Ottaviani aimed to address some of these issues in  a new study published in PLOS one, which utilised the University of Michigan’s institutional repository service, Deep Blue. OA articles (n=3,850) were selected that previously were subscription only but had been made available in Deep Blue via blanket licensing agreements between the publisher and library, and therefore were not self-selected for OA by the author. These were compared with articles from the same journal which remained subscription only (n=89,895). The number of citations were recorded for the OA articles while access was open and closed and compared with articles that remained closed during the same time period. The study found that an OACA as high as 19% exists, and that better articles gain more from OA.

The author describes the limitations of the data including the fact that many articles were past their peak citation years and concludes by discussing the difficulties and current barriers to carrying out this type of research.


Summary by Alice Wareham, PhD from Aspire Scientific

Will ‘results-free’ peer review reduce publication bias?

BMC Psychology is launching a pilot study ahead of a planned randomised controlled trial to investigate whether a results-free peer review process will lead to less publication bias. While null results are seen as scientifically important, it is currently less likely that such studies will be published compared with those with positive results. It is postulated that results-free peer review could reduce bias, and increase publication of studies with strong rationale and design.

A press release from BioMed Central, which publishes the journal, explains that reviewers of research manuscripts submitted for publication will not be able to see the results or discussion sections until the end of the review process. A publication decision would instead be based on the study premise and methods only. After investigating whether results-free peer review is viable, a trial will compare it to the standard process.

While results-free peer review could be effective in reducing publication bias in the social sciences, some doubt its applicability to other fields, such as the physical sciences. In many fields, experimental techniques are fairly standard and the results and discussion sections are vital for judging the importance of the study.



Summary by Philippa Flemming, PhD from Aspire Scientific.

[VIDEO] Been there, done it, got the tee-shirt. Life in MedComms

In this video, Rick Flemming (Director at Aspire Scientific) talks about his career in Medical Communications (MedComms) and what to expect when working as a medical writer.

Recorded 6 October 2016 at a MedComms Networking event in Oxford. Produced by NetworkPharma.tv

Rick’s presentation (PDF format) is at http://medcommsnetworking.com/present…

Struggle with statistics? Help is at hand

The field of statistics can feel bewildering to non-experts, yet all medical writers need to have an awareness of the subject in order to do their job properly. For the uninitiated, help is at hand with a special edition of Medical Writing (the official journal of the European Medical Writers Association) dedicated to the topic.

It begins with the “History of biostatistics” by J. Rosser Matthews, which looks at the key milestones and how they have shaped clinical trial design.

This is followed by “Never P alone: The value of estimates and confidence intervals”, in which Tom Lang outlines the importance of providing confidence intervals and not just a P value. He also co-authors an article with Douglas G. Altman describing the current SAMPL (Statistical Analyses and Methods in the Published Literature) guidelines. Adam Jacobs provides advice on how to write meta analyses in “A medical writer’s guide to meta-analysis”, while Diogo Bruno explains study design in “Study design made easy”. How to report odds ratios, hazard ratios and β-coefficients is covered in “How to interpret and report the results from multivariable analyses” by Stephen Gilliver and Neus Valveny. Finally, two articles cover the special relationship that is needed between biostatistician and medical writer to ensure smooth and high-quality document preparation; “Best friends forever: A pattern of collaboration between medical writers and biostatisticians within the Russian CRO” by Ivan Dobromyslov and Eugenia Radkova and “Biostatistics and medical writing: Synergy in preparing clinical trials documents” by Raquel Billiones and Scott Miller.

This focused edition of Medical Writing should prove invaluable to anyone looking to improve their biostatistics knowledge.



Summary by Jo Chapman, PhD from Aspire Scientific.

Does author prestige influence peer review?

A recent research study (NCT02739737) published as a letter in JAMA has investigated whether author prestige affects the outcome of peer review. The study was conducted at Clinical Orthopaedics and Related Research (CORR), a journal which allows authors to select single-blind review (where authors’ identities are known to the peer reviewers) or double-blind review (where authors’ identities are masked). Researchers fabricated a manuscript using two prestigious surgeons from prominent institutions as the alleged authors and sent the paper to peer reviewers via CORR. One hundred and nineteen reviewers completed a review of the manuscript. These reviewers had previously given consent to take part in the study but were unaware at the time of review that the manuscript was part of the study. Half of the participants reviewed a single-blind version and the other half reviewed a double-blind version of the manuscript.

Reviewers were more likely to recommend acceptance of the manuscript when the prestigious authors’ identities and institutions were known than when they were not (87% vs 68%, p=0.02). Higher ratings for the Methods, Results and Discussion sections were also given when the authors’ identities were known. The number of intentionally placed errors detected did not differ between the two groups.



Summary by Philippa Flemming, PhD from Aspire Scientific.