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WHAT'S THIS?
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COMMENTARY << Best practice
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Is a subgroup effect believable? Updating criteria to evaluate the credibility of subgroup analyses
Published 30 March 2010
How can we tell the difference between spurious and real subgroup effects? This article in the BMJ identifies new criteria and proposes a checklist for judging the credibility of subgroup analyses.
[Link to original source material]
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Requirements and Definitions in Conflict of Interest Policies of Medical Journals
Published 25 November 2009
Jared A. Blum and colleagues report in JAMA a study to determine the prevalence of author COI policies, requirements for signed disclosure statements, and variability in COI definitions among medical journals. They conclude that in 2008, most medical journals with relatively high impact factors had author COI policies available for public review. Among journals, there was substantial variation in policies for solicitation of author COIs and in definitions of COI.
[Link to original source material]
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New Conflict Rules at Medical Journals
Published 14 October 2009
An article in the The Wall Street Journal reports the new ICMJE guidelines on disclosure of competing interests. It highlights the requirement for non-financial disclosures as one area that could be controversial.
[Link to original source material]
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Disclosure of competing interests: A new standardised format that all journals could use
Published 12 October 2009
Jeffrey M Drazen, editor in chief, New England Journal of Medicine and colleagues present in an Editorial in the BMJ (and in all other ICMJE Journals) a new disclosure form that has been adopted by all journals that are members of the ICMJE. By adopting a uniform format, they hope to make the process of disclosure of competing interests easier for authors and less confusing for readers.
[Link to original source material]
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PRISMAtic reporting of systematic reviews and meta-analyses
Published 10 October 2009
The Lancet reports that PRISMA, which has recently been published in several journals, will replace the QUOROM statement. PRISMA stands for Preferred Reporting Items for Systematic reviews and Meta-Analyses (table), and thus covers both meta-analyses and systematic reviews, whereas QUOROM (QUality Of Reporting Of Meta-analyses) focused on meta-analyses only.
[Link to original source material]
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The damning verdict on drug trials
Published 3 October 2009
A Bad Science column in the Guardian online about the failure of the industry to publish trial results reliably and in full.
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The gold standard
Published 1 October 2009
Alfred Weigel writes an article in PMLive.com about how the Certified Medical Publication Professional (CMPP) credential reflects the evolution of an industry that is striving to raise the bar of professionalism and competency in its medical publication planning activities
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Are medical journals getting better — or worse?
Published 19 September 2009
An Editorial in The Lancet reflects on last week's Peer Review conference in Vancouver and bemoans what it sees as a decline in interest in studying and in improving the quality of the science of journals and journal editing.
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Highlights from the Fifth Annual Meeting of the International Society for Medical Publication Professionals
Published 18 September 2009
The 5th Annual Meeting of the International Society of Medical Publication Professionals (ISMPP), held April 20 to April 22, at the Sheraton Philadelphia City Center Hotel in Philadelphia, Pennsylvania, saw publication professionals from around the globe gather to further define the role of the medical publication professional in light of the changing medical publications industry.
[Link to original source material]
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Self-plagiarism: unintentional, harmless, or fraud?
Published 29 August 2009
A short Editorial in the Lancet ponders the point that Journals are increasingly seeing submissions in which large parts of text have been copied from previously published papers by the same author and states "Whereas plagiarism—copying from others—is widely condemned and regarded as intellectual theft, the concept of self-plagiarism is less well defined."
[Link to original source material]
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New methods to deal with publication bias
Published 26 August 2009
An Editorial by Hans-Hermann Dubben in the BMJ argues that the funnel plot and related methods are worthwhile tools at least until all trials have been registered in advance. They allow us to interpret currently accessible studies with necessary caution, and to identify authors and companies who conceal data.
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Novel methods to deal with publication biases: secondary analysis of antidepressant trials in the FDA trial registry database and related journal publications
Published 7 August 2009
Open access paper in the BMJ reports that novel contour enhanced funnel plots and a regression based adjustment method worked convincingly and might have an important part to play in combating publication biases.
[Link to original source material]
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Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement
Published 21 July 2009
In 1996, to address the suboptimal reporting of meta-analyses, an international group developed a guidance called the QUOROM statement (QUality Of Reporting Of Meta-analyses), which focused on the reporting of meta-analyses of randomised controlled trials. This article summarises a revision of these guidelines, renamed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses), which have been updated to address several conceptual and practical advances in the science of systematic reviews.
[Link to original source material]
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The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration
Published 21 July 2009
The PRISMA statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review.
[Link to original source material]
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Can the Relationship between Doctors and Drug Companies Ever Be a Healthy One?
Published 21 July 2009
In a PLOS Medicine Debate, Emma D'Arcy, co-founder of a social networking site that facilitates interactions between doctors and drug companies, argues that it would be valuable to the public if we could establish “authentic alliances” between these professionals. But journalist Ray Moynihan argues that such alliances are prone to the corrupting influence of pharmaceutical industry money, and that disentanglement is a healthier alternative.
[Link to original source material]
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High proportion of trials published in Chinese medical journals are flawed, study shows
Published 7 July 2009
Jacqui Wise reports in the BMJ about a review published in the open access online journal Trials which concludes that the design of more than 90% of around 2000 randomised controlled trials published in Chinese medical journals was flawed.
[Link to original source material]
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Papers with industry ties: Classic confounding conflicts
Published 15 June 2009
Stephen J Evans, Professor of Pharmacoepidemiology takes issue with a previous paper in BMJ, Cancer research papers with industry ties more likely to report favourable results, published 20 May 2009.
[Link to original source material]
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Incomplete reporting of research in academic press releases
Published 5 June 2009
An Editorial in The Lancet reflects on a paper previously published in Annals of Internal Medicine about the poor quality and incomplete reporting shown by press releases issued by medical schools in the US. It suggests a simple tool that could be adapted to assure that press releases contain the necessary details for journalists to provide more informed coverage is the CONSORT reporting guideline for abstracts, paraphrased as: how done, how many, how effective, how important, how funded. Journalists and their audiences should expect this information as a minimum standard.
[Link to original source material]
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Aligning Aspirations and Realising Ambitions: the challenges of the new era of engagement between experts and the pharmaceutical industry
Published 25 May 2009
In this timely and comprehensive Expert Review, Emma D’Arcy of myPHID argues that the future of interactions between industry and the medical community will be about openly aligning aspirations and ambitions. Published in the KeywordPharma Expert Reviews series, the full report is available to download free of charge, sponsored by Fishawack Communications.
[Link to original source material]
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Cancer research papers with industry ties more likely to report favourable results
Published 20 May 2009
Janice Hopkins Tanne reflects in the BMJ on the report from researchers at the University of Michigan (Cancer 2009 May 11) that conflicts of interest are common in research papers on cancer, and papers with conflicts are more likely to report positive results.
[Link to original source material]
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Does the FDA have the authority to trump the Declaration of Helsinki?
Published 21 April 2009
The BMJ reports that the Food and Drug Administration (FDA) of the United States has ruled that clinical trials performed outside the US no longer have to conform to the Declaration of Helsinki if used to support applications for registration of products in the US. Instead, the International Conference on Harmonisation Good Clinical Practice (GCP) has been designated as the new regulatory standard.
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Shifting Terrain in the Regulation of Off-Label Promotion of Pharmaceuticals
Published 9 April 2009
NEJM article on the good reprint practice guidelines from the FDA.
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Managing UK research data for future use
Published 25 March 2009
For some time the BMJ says it has been watching other journals’ efforts to encourage authors to make raw research data available. Now they are taking part too, by asking authors to include a data sharing statement at the end of each original research article. The statement will explain which additional data - if any - are available, to whom, and how.
[Link to original source material]
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Protocols, probity, and publication
Published 21 March 2009
Comment in The Lancet announces that to help authors demonstrate that their findings are faithful to their research protocol, The Lancet, The Lancet Oncology, and The Lancet Neurology now offer to publish links to the full study protocol on the authors' institutional website. They believe this idea should be more widely practiced.
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Towards agreement on best practice for publishing raw clinical trial data
Published 18 March 2009
This article discusses the issue of publication of raw trial data, and outlines potential next steps and alternatives to journal publication.
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FDA allows drug firms to distribute journal articles about unapproved uses
Published 19 January 2009
BMJ commentary on the FDA guidance to industry on good reprint practices for unapproved indications.
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Guidance for Industry. Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices
Published 13 January 2009
FDA guidance for pharma on distribution of reprints discussing unapproved indications.
[Link to original source material]
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Wyeth’s Use of Medical Ghostwriters Questioned
Published 12 December 2008
This article in the New York Times reports that Wyeth, the pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its hormone replacement therapy Prempro, according to Congressional letters seeking more information about the companys involvement in medical ghostwriting. At least one article was published even after a federal study found the drug raised the risk of breast cancer.
[Link to original source material]
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Making Sense of Non-Financial Competing Interests
Published 30 September 2008
This editorial by PLoS Medicine editors explores the potential impact of non-financial competing interests (or private interests).
[Link to original source material]
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Patient confidentiality and consent to publication
Published 10 September 2008
An editorial in the BMJ discusses the impact of the UK Data Protection Act on publication of case histories with regard to obtaining patient consent for publication. The article links to several other articles discussing the ethics of publishing a case history which the BMJ declined 2 years ago because patient consent could not be obtained – the article was subsequently published in an Australian journal (where the authors are based).
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The role and responsibilities of co-authors
Published 6 September 2008
The Lancet provides an editorial emphasising that co-authors must take responsibility for the integrity of the published work and condemning guest authorship. This follows retraction of an article from an academic research group after serious flaws in its conduct were found and the subsequent attempts of some co-authors to distance themselves from the work.
[Link to original source material]
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Industry-sponsored clinical research: a broken system
Published 3 September 2008
Critical discussion in JAMA on industry support of clinical trials.
[Link to original source material]
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The role of healthcare communications agencies in maintaining compliance when working with the pharmaceutical industry and healthcare professionals
Published May 2008
In this CMRO article, Angela Cairns and Yvonne Yarker of Gardiner-Caldwell Communications and Scientific Connexions discuss the internal processes of their group of companies to ensure compliance with GPP.
[Link to original source material]
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Nothing to see here
Published May 2008
An editorial in Nature Biotechnology delivers a stinging criticism of the JAMA articles on the use of ghostwriters and guest authors by Merck in preparation of Vioxx publications. It points out that pharmaceutical research is a team effort, so it is hardly surprising that some people conduct the research, whilst others write the papers. The article also highlights that Merck's publication practices 5 years ago pre-date guidelines that most pharma companies currently follow. Although the Nature editorial agrees with many of the JAMA recommendations to crack down on ghostwriters and guest authors (most of which are included in current industry publication practice guidelines), it believes that some recommendations go too far and imply that all industry research is somehow unreliable. It concludes that stigmatising all papers from industry on the basis of the Vioxx analysis is unjustified and discriminatory.
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Bridging the divide: a call for a Medical Publishing Cooperative. An interview with Daniel J Donovan
Published Q2 2008
This article in the Journal of the American Medical Writers Association (AMWA) describes Dan Donovan's idea to establish a Medical Publishing Cooperative. He proposes to include representatives from the pharma industry and agencies, publishers, journal editors, the International Committee of Medical Journal Editors (ICMJE), academia, AMWA, The International Publication Planning Association (TIPPA) and the International Association for Medical Publication Professionals (ISMPP), with the aim of getting the different stakeholders to understand each others' roles and points of view. The ultimate goal is to 'find common ground that will be marked by acceptance of all the players and the roles that they perform in medical publications'. Dan hopes that the group would come up with solutions that respect the roles of the different parties and produce positive change in the medical publications arena.
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Impugning the integrity of medical science. The adverse effects of industry influence
Published 16 April 2008
Here, the Editor-in-Chief and Executive Deputy Editor of JAMA comment on two related articles in the April 2008 issues about rofecoxib publications. They also make some far-reaching suggestions about actions that journals could take to improve transparency of industry involvement and reduce the potential for data manipulation e.g. industry sponsors of clinical trials should not take primary responsibility for data collection and analysis and preparation of manuscripts; statistical analysis should be conducted by independent statisticians; physicians should not participate in speaker's bureaux nor accept gifts.
[Link to original source material
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The dangers of polarization in publications
Published October 2007
This poster by Dan Donovan, presented at the 2007 conference of the American Association of Medical Writers, describes the dangers of stakeholders in the publication planning arena taking up entrenched positions that are becoming increasingly extreme..
[Link to original source material]
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Ghost management: How much of the medical literature is shaped behind the scenes by the pharmaceutical industry?
Published September 2007
An interesting article in PLoS Medicine looking beyond 'ghost writing' to 'ghost management' of publications.
[Link to original source material]
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International Society for Medical Publication Professionals (ISMPP) position statement: the role of the professional medical writer
Published 29 June 2007
This position statement and support for the role of the professional medical writer from ISMPP was published in Current Medical Research and Opinion.
[Link to original source material]
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Medical writers and peer-reviewed journals: understanding the rules and responsibilities
Published 18 June 2007
Liz Wager explains the concerns about the role of medical writers in developing peer-reviewed publications and helps writers and communications companies keep abreast of recent guidelines and new journal policies. Published in the KeywordPharma Expert Reviews series, the full report is available to download free of charge, sponsored by Caudex.
[Link to original source material]
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Best practice guidelines on publication ethics: a publisher's perspective
Published 29 November 2006
This article from Blackwell Publishers, published in the International Journal of Clinical Practice, describes their position on ethical principles of scientific publishing. It covers aspects such as editorial standards and processes, transparency of funding, research integrity and ownership of ideas.
[Link to original source material]
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Good Publication Practice: why we need another set of guidelines
Published 23 April 2003
This 3-way group of representatives from industry, journal editors and academia got together in 1998 to discuss and improve understanding of how publications from industry-sponsored research are developed. The meeting led to the production of the Good Publication Practice (GPP) guidelines, Good Publication Practice: Guidelines for Pharmaceutical Companies.
[Link to original source material]
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WHAT ELSE?
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NEWS ALERT!
Do you want to be alerted to important news and events relevant to publication planning?
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Strategic Medcomms Forum 2010: Reshaping the healthcare conversation
30 September 2010
Oxford University Musuem
The first of a series of annual events where we consider how the global medical and pharmaceutical industry engages with its stakeholders and we identify and debate future directions and implications for medical-marketing activity.
[View details here]
Organized by NetworkPharma.
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