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Access to data in industry-sponsored trials
Published 10 December 2011
This article by Andreas Lundh and colleagues in The Lancet, highlights the confusion over what is meant by "full access to data" and concludes that we should work towards a situation in which anonymised raw data are made freely available to the public. Saying "Our patients deserve nothing less than this, which would be highly beneficial for health care."
[Link to original source material]
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Publication of clinical trial data: enough of the excuses!
Published 29 November 2011
How much negative data goes unpublished? Ryan Woodrow set to find out and his surprising results are detailed here in an article in pharmaphorum.
[Link to original source material]
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Should journals sell reprints?
Published 14 October 2011
A Head to Head feature in the BMJ:
Should journals sell reprints? Yes - from Jane Smith
Should journals sell reprints? No - from Tom Jefferson
[Link to original source material - YES]
[Link to original source material - NO]
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Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8
Published 26 September 2011
N M Ivers and colleagues conclude in their BMJ article that overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal, and further efforts are needed to improve both reporting and methodology.
[Link to original source material]
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Multiplicity of data in trial reports and the reliability of meta-analyses: empirical study
Published 30 August 2011
Britta Tendal and colleagues conclude in their BMJ article that multiplicity of data can affect the findings of systematic reviews and meta-analyses. To reduce the risk of bias, reviews and meta-analyses should comply with prespecified protocols that clearly identify time points, intervention groups, and scales of interest.
[Link to original source material]
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Peer review system must be overhauled and improved, say MPs
Published 28 July 2011
Adrian O'Dowd reports in the BMJ that the peer review system used by many medical journals before they publish new research is in need of a radical overhaul with more checks, transparency, regulation, and sharing of best practice, according to a report from MPs
[Link to original source material]
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Peer review must stay as guarantee of quality, research leaders tell MPs
Published 9 June 2011
Adrian O'Dowd reports in the BMJ that the quality of scientific research can be guaranteed only by the continued use of peer review by journals, research leaders have told an inquiry by MPs.
[Link to original source material]
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Peer review system needs thorough evaluation, MPs hear
Published 16 May 2011
Adrian O’Dowd reports in the BMJ that several medical and scientific journal editors appearing before the (UK) parliamentary science and technology select committee on 11 May spoke of the many merits of peer review, but they raised some concerns about the variability of its quality and a lack of adequate evaluation of the system.
[Link to original source material]
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Experts deny claims that peer review system is in crisis
Published 5 May 2011
Adrian O’Dowd writes in the BMJ that experts have defended the peer review system used by many medical journals before publishing new research and denied claims that it is in “crisis.”
[Link to original source material]
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Making raw data more widely available
Published 4 May 2011
Andrew J Vickers write in the BMJ that a new initiative by the Wellcome Trust sets out some guiding principles and says his recommendation to the medical research community is: get used to it. Once medical researchers start publishing their data, and depositing it in data archives, they will discover not only that it is painless, but that it affords huge advantages to medical science, and to patients present and future.
[Link to original source material]
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Economic evaluation alongside randomised controlled trials: design, conduct, analysis, and reporting
Published 7 April 2011
Stavros Petrou and Alastair Gray write in the BMJ that collecting economic data at the same time as evidence of effectiveness maximises the information available for analysis but requires proper consideration at the design stage
[Link to original source material]
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Transparency: the journey begins
Published 5 April 2011
Cate Foster writes in PMLive that transparency is a current watchword within all aspects of publication planning and helpful advances have been made in recent years. However, the question is: how far down the road of increased transparency should the industry travel?
[Link to original source material]
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The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review
Published 28 March 2011
Open Access article in the BMJ concludes that Subgroup analyses from industry funded trials with negative results for the primary outcome should be viewed with caution.
[Link to original source material]
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Postmarketing studies of drug safety
Published 8 February 2011
This Editorial by Sebastian Schneeweiss and Jerry Avorn in the BMJ explains how a European initiative could help bring more transparency and rigour to pharmacoepidemiology.
[Link to original source material]
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Strategy for intention to treat analysis in randomised trials with missing outcome data
Published 7 February 2011
Loss to follow-up is often hard to avoid in randomised trials. This article by Ian White and colleagues in the BMJ suggests a framework for intention to treat analysis that depends on making plausible assumptions about the missing data and including all participants in sensitivity analyses
[Link to original source material]
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Access to clinical trial data
Published 12 January 2011
This Editorial in the BMJ by An-Wen Chan concludes that Public access to the full trial protocol and raw dataset is essential for the value or harm of an intervention to be adequately appraised. Stakeholders have a responsibility to try to prevent the consequences of data suppression. Failure to act will perpetuate the status quo of partially informed decision making and will compromise patient care.
[Link to original source material]
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Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists
Published 6 January 2011
This open access article in the BMJ concludes that the prevalence of incomplete outcome reporting is high. Trialists seemed generally unaware of the implications for the evidence base of not reporting all outcomes and protocol changes. A general lack of consensus regarding the choice of outcomes in particular clinical settings was evident and affects trial design, conduct, analysis, and reporting.
[Link to original source material]
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Is open peer review the fairest system? Yes
Published 16 November 2010
Trish Groves argues in the BMJ that telling authors who has reviewed their paper has helped to make the process fairer, but Karim Khan (doi:10.1136/bmj.c6425) is concerned that it stops reviewers from being completely frank
[Link to original source material]
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Is open peer review the fairest system? No
Published 16 November 2010
Trish Groves argues in the BMJ that telling authors who has reviewed their paper has helped to make the process fairer, but Karim Khan (doi:10.1136/bmj.c6425) is concerned that it stops reviewers from being completely frank
[Link to original source material]
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Effect on peer review of telling reviewers that their signed reviews might be posted on the web: randomised controlled trial
Published 16 November 2010
Susan van Rooyen and colleagues report in the BMJ that in their study telling peer reviewers that their signed reviews might be available in the public domain on the BMJ’s website had no important effect on review quality though it did appear to increase refusal rates amongst potential peer-reviewers and a longer time to write the reviews.
[Link to original source material]
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Conflicts of Interest at Medical Journals: The Influence of Industry-Supported Randomised Trials on Journal Impact Factors and Revenue – Cohort Study
Published 26 October 2010
Andreas Lundh and colleagues writing in PLoS Medicine suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals' revenue and impact.
[Link to original source material]
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Report of The International Publication Planning Association’s 2010 8th Annual Meeting
Published 21 October 2010
An in-depth report from the International Publication Planning Association's 2010 8th Annual Meeting held in San Francisco, CA, USA, 24-25 June 2010. Written by Kate Hasal. Published in the KeywordPharma Conference Insights series, the full report is available to download free of charge, sponsored by Adis, a Wolters Kluwer business.
[Link to original source material]
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Industry sponsored bias in cost effectiveness analyses
Published 13 October 2010
Ava John-Baptiste and Chaim Bell write in the BMJ about how evidence is growing that the involvement of industry in cost effectiveness analyses can affect the findings
[Link to original source material]
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Missing clinical trial data: setting the record straight
Published 12 October 2010
Fiona Godlee's Editorial in the BMJ argues that urgent action is needed to restore the integrity of the medical evidence base. She says the reboxetine story and similar episodes raise fundamental questions.
[Link to original source material]
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Merging of marketing and medical science: female sexual dysfunction
Published 30 September 2010
Ray Moynihan describes in the BMJ how, whilst researching his latest book, he uncovered how drug companies helped construct the scientific building blocks of a new condition and asks whether we need a fresh approach to defining disease.
[Link to original source material]
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Seventy-Five Trials and Eleven Systematic Reviews a Day: How Will We Ever Keep Up?
Published 21 September 2010
Hilda Bastian and colleagues write in PLoS Medicine that to meet the needs of patients, clinicians, and policymakers, unnecessary trials need to be reduced, and systematic reviews need to be prioritised, That streamlining and innovation in methods of systematic reviewing are necessary to enable valid answers to be found for most patient questions and that, finally, clinicians and patients require open access to these important resources.
[Link to original source material]
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The need to consider the wider agenda in systematic reviews and meta-analyses: breadth, timing, and depth of the evidence
Published 13 September 2010
An articles by John Ioannidis and Fotini Karassa in the BMJ argues that as well as focusing on a precise question, systematic reviewers also need to consider the whole research programme for the interventions under study.
[Link to original source material]
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Inadequate post-publication review of medical research
Published 11 August 2010
David L Schriger and Douglas G Altman write in the BMJ about the sad lack of critique of publications after publiction. "Most research articles in medical journals receive no critique, and, for the minority that do, authors often do not reply or reply but do not respond to the criticism."
[Link to original source material]
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Outcome Reporting Among Drug Trials Registered in ClinicalTrials.gov
Published 3 August 2010
A new study in Annals of Internal Medicine suggests that drug studies funded by industry are significantly more likely to have favourable outcomes than those funded by the government or non-profit groups.
[Link to original source material]
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Access granted
Published 2 August 2010
Writing in PM Live, Sarah Feeny and Russell Traynor (both of ISMPP) review the discussions at the 6th International Society for Medical Publication Professionals (ISMPP) Annual Meeting about the emergence of new communication routes, such as social networks, live information feeds, enhanced web portals and open access publishing, along with the impact of these technologies and approaches on medical publications.
[Link to original source material]
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Don't Mess with the DSMB
Published 29 July 2010
Jeffrey M. Drazen, M.D. and Alastair J.J. Wood writing in the NEJM, call for fundamental changes in the way DSMBs (data and safety monitoring boards) are constituted, are funded, and report, regardless of whether there is a commercial or a public sponsor. They propose that to prevent sponsors from interfering with an ongoing study, the trial steering committee would report only to the DSMB.
[Link to original source material]
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Disclosing Industry Relationships — Toward an Improved Federal Research Policy
Published 14 July 2010
Eric G. Campbell and Darren E. Zinner writing in the NEJM, review moves for more stringent requirements for academic researchers to reveal industry payments.
[Link to original source material]
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Modified intention to treat reporting in randomised controlled trials: systematic review
Published 14 June 2010
An article by Iosief Abraha in the BMJ describes a study to determine the incidence and characteristics of randomised controlled trials that report using the modified intention to treat approach, and how the approach is described.
[Link to original source material]
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EU drugs agency slammed again over data access
Published 9 June 2010
Lynne Taylor reports in PharmaTimes that the European Medicines Agency’s refusal to allow researchers access to trial documents relating to two anti-obesity drugs has been ruled “an instance of maladministration,” by the European Ombudsman.
[Link to original source material]
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Report of The International Publication Planning Associations 2010 Midwest Meeting: tackling the authorship debate in publication planning
Published 11 May 2010
An in-depth report from the Midwest Meeting of the International Publication Planning Association (TIPPA) held in Chicago, Illinois, USA, 25-26 February 2010. Written by Clare Nolan. Published in the KeywordPharma Conference Insights series, the full report is available to download free of charge, sponsored by Wolters Kluwer.
[Link to original source material]
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Enhancing transparency and efficiency in reporting industry-sponsored clinical research: report from the Medical Publishing Insights and Practices initiative
Published 7 May 2010
J Clark and colleagues write in The International Journal of Clinical Practice that despite advances in technology, publication of trial results in the form of conventional studies in peer-review journals remains the gold standard of scientific disclosure.
[Link to original source material]
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CONSORT 2010 changes and testing blindness in RCTs
Published 3 April 2010
Kenneth F Schulz and colleagues take the opportunity in The Lancet to clarify their position on evaluating tests for blindness. They note that CONSORT distinguishes between reporting and conduct and that CONSORT only addresses reporting: what was done and what was found.
[Link to original source material]
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The new CONSORT statement
Published 23 March 2010
This Editorial by Gerd Antes in the BMJ concludes that the guidance is clear, but awareness and endorsement are lagging behind.
[Link to original source material]
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CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
Published 23 March 2010
The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues in the BMJ describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience.
[Link to original source material]
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CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials
Published 23 March 2010
This explanatory and elaboration article in the BMJ is intended to enhance the use, understanding, and dissemination of the updated CONSORT statement.
[Link to original source material]
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The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed
Published 23 March 2010
This open-access article in the BMJ by Sally Hopewell and colleagues concludes that reporting of several important aspects of trial methods improved between 2000 and 2006; however, the quality of reporting remains well below an acceptable level.
[Link to original source material]
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Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design
Published 19 March 2010
Pragmatic trials are important for informing routine clinical practice, but current designs have shortcomings. An article in the BMJ by Clare Relton and colleagues outlines the new "cohort multiple randomised controlled trial" design, which could help address the problems associated with existing approaches.
[Link to original source material]
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Problems with peer review
Published 15 March 2010
This article in the BMJ reflects on several recent high profile cases that have raised questions about the effectiveness of peer review in ensuring the quality of published research. Mark Henderson reviews the current landscape and reports that the BMJ is about to start publishing its signed reviews alongside published papers after a randomised trial found this feasible and acceptable to authors and reviewers. Meanwhile Nature is considering the anonymous publication of referees’ reports.
[Link to original source material]
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Time for fair trade in research data
Published 27 February 2010
Elizabeth Pisani and colleagues write in The Lancet about how Geneticists, astrophysicists, and molecular biologists routinely share research data with colleagues and rivals alike. The reason is that scientists and their funders know we will understand complex issues sooner if people build on one another's work. Yet scientists in the complex area of public health have been left behind in the data-sharing revolution.
[Link to original source material]
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The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews
Published 15 February 2010
Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane reviews. Individuals conducting systematic reviews need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence. Extra care is required during data extraction, reviewers should identify when a trial reports that an outcome was measured but no results were reported or events observed, and contact with trialists should be encouraged.
[Link to original source material]
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Meta-analysis of individual participant data: rationale, conduct, and reporting
Published 5 February 2010
The use of individual participant data instead of aggregate data in meta-analyses has many potential advantages, both statistically and clinically. Richard D Riley and colleagues describe the rationale for an individual participant data meta-analysis and outline how to conduct this type of study in this BMJ article.
[Link to original source material]
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Stem cell researchers claim some reviewers hamper publication of high quality research
Published 4 February 2010
Susan Mayor writes in the BMJ about the leading stem cell researchers who have expressed concern that some reviewers may be hampering publication of high quality research in the field and are calling for a more open process of review to prevent this.
[Link to original source material]
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Liz Wager on stem cell scientists’ criticisms of peer review
Published 2 February 2010
Liz Wager reflects on the need for Journal Editors to think about their peer review systems in her BMJ Blog.
[Link to original source material]
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The perils of journal and supplement publishing
Published 30 January 2010
An Editorial in The Lancet takes the opportunity to make the point that it does not publish commercially sponsored supplements while questioning the recent distribution of a “Satellites” supplement with the official journal of the European League Against Rheumatism (EULAR), sponsored by pharmaceutical company, NicOx. The Lancet says, "Publishing supplements is a perilous business. And editors will always need to be vigilant in making sure that their journal's good name is not abused."
[Link to original source material]
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BMJ policy on data sharing
Published 28 January 2010
The BMJ, explains its position and support for the view that researchers should seek informed consent to data sharing from research participants upfront, at the recruitment stage.
[Link to original source material]
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Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers
Published 28 January 2010
Many peer reviewed journals now require authors to be prepared to share their raw, unprocessed data with other scientists or state the availability of raw data in published articles, but little information on how such data should be prepared for sharing has emerged. In this article in the BMJ, Iain Hrynaszkiewicz and colleagues propose a minimum standard for de-identifying datasets to ensure patient privacy when sharing clinical research data.
[Link to original source material]
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AMWA's 69th Annual Conference
Published December 2009
A report from AMWA's 69th Annual Conference, held in Dallas in October 2009, published in AMWA JOURNAL VOL. 24, NO. 4, 2009. Includes the full transcript of Karen Wooley's Keynote Address, "Getting Respect—Two Steps Forward and...?"
[Link to original source material]
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COPE's retraction guidelines
Published 5 December 2009
Sabine Kleinert writes about the new COPE guidelines in The Lancet
[Link to original source material]
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Is the conflict of interest unacceptable when drug companies conduct trials on their own drugs?
Published 29 November 2009
Head to head feature published in the BMJ. Drug companies produce most of the evidence on which we base medical practice. Is this an unacceptable conflict of interest? Yes, says Ben Goldacre. He argues that the financial interests of drug companies lead to distorted evidence. No, says Vincent Lawton. He believes that adequate safeguards exist to keep bias in check.
[Link to Yes, says Ben Goldacre]
[Link to No, says Vincent Lawton]
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The FDA's poor oversight of postmarketing studies
Published 7 November 2009
The Lancet reports that according to a new report by the Government Accountability Office (GAO), the FDA is failing to properly oversee postmarketing studies of drugs approved on the basis of surrogate endpoints.
[Link to original source material]
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Professor is charged with dishonesty over statements on access to full trial data
Published 3 November 2009
The BMJ reports that the former research dean of Sheffield University’s medical school was accused of dishonesty at a General Medical Council hearing on 2 November for allowing a journal to publish a false claim that he had seen all the data in a research study of which he was the lead author.
[Link to original source material]
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The beginning of the end for impact factors and journals
Published 2 November 2009
A BMJ Group Blog from Richard Smith, former Editor of the BMJ who argues that the introduction of article level metrics by the Public Library of Science (PLoS) will almost certainly end the tyranny of impact factors and may well mark another step towards the extinction of most scientific journals.
[Link to original source material]
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Report of The International Publication Planning Associations 7th Annual Meeting
Published 18 September 2009
An in-depth report from the 7th Annual Meeting of the International Publication Planning Association (TIPPA) held in San Francisco, CA, USA, 15-16 June 2009. Written by Elizabeth (Liz) Wager. Published in the KeywordPharma Conference Insights series, the full report is available to download free of charge, sponsored by Wolters Kluwer.
[Link to original source material]
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Researchers, like politicians, use "spin" in presenting their results, conference hears
Published 15 September 2009
Mabel Chew reports in the BMJ that politicians are not alone in using "spin" to sway their constituents. Researchers do too, according to two presentations at the International Congress of Peer Review and Biomedical Publication in Vancouver, Canada. Two preliminary explorations of this phenomenon were presented, one on studies with non-significant results, the other on studies claiming positive results.
[Link to original source material]
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Nine in 10 articles rejected by NEJM appear in another journal
Published 14 September 2009
Trish Groves reports in the BMJ the results of a study to determine what proportion of papers rejected by the New England Journal of Medicine eventually get published elsewhere which was presented at the international peer review conference in Vancouver last week.
[Link to original source material]
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Comparisons of Citations in Web of Science, Scopus, and Google Scholar for Articles Published in General Medical Journals
Published 9 September 2009
A paper in JAMA concludes that Web of Science, Scopus, and Google Scholar produced quantitatively and qualitatively different citation counts for articles published in 3 general medical journals.
[Link to original source material]
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The Journal Impact Factor Denominator: Defining Citable (Counted) Items
Published 9 September 2009
A Commentary in JAMA states that in an environment eager for objective measures of productivity, relevance, and research value, the impact factor has been applied broadly and indiscriminately.
[Link to original source material]
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The effects of excluding patients from the analysis in randomised controlled trials: meta-epidemiological study
Published 7 September 2009
A research article from Eveline Nüesch and colleagues in the BMJ concludes that excluding patients from the analysis in randomised trials often results in biased estimates of treatment effects, but the extent and direction of bias is unpredictable. Results from intention to treat analyses should always be described in reports of randomised trials. In systematic reviews, the influence of exclusions from the analysis on estimated treatment effects should routinely be assessed.
[Link to original source material]
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Disclosure of Financial Relationships to Participants in Clinical Research
Published 27 August 2009
A paper in the NEJM discusses the options and implications of several techniques for managing conflicts of interest to ensure the integrity of clinical research.
[Link to original source material]
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Premature Release of Data from Clinical Trials of Ezetimibe
Published 13 August 2009
A paper in the NEJM discusses the circumstances that led to the unexpected and untimely release of safety data surrounding cancer-associated results from ongoing trials of ezetimibe and presents recommendations for addressing such premature release in the future.
[Link to original source material]
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European and US agencies will cooperate to ensure ethical conduct of trials
Published 10 August 2009
The BMJ reports that the US Food and Drug Administration and the European Medicines Agency (EMEA) have announced that they will work together to ensure that clinical trials "related to drug marketing applications" in the United States and Europe are conducted "uniformly, appropriately, and ethically."
[Link to original source material]
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Elsevier should divest itself of either its medical publishing or pharmaceutical services division
Published 31 July 2009
More fall out from the "Fake Merck Journal" story.
Jon Jureidini and Robyn Clothier of Healthy Skepticism write to the Lancet stating "Although the relationship between medical publishing and service to the pharmaceutical industry is not unique to Elsevier, we question the compatibility of these two roles."
[Link to original source material]
Thomas Reller writes a response from Elsevier
[Link to original source material]
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How citation distortions create unfounded authority: analysis of a citation network
Published 21 July 2009
Steven A Greenberg reports in the BMJ his study to understand belief in a specific scientific claim by studying the pattern of citations among papers stating it.
[Link to original source material]
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JAMA should change its policy on investigating competing interests, AMA says
Published 21 July 2009
A news report in the BMJ highlights the new policy at JAMA on competing interests and questions the way in which it has been published.
[Link to original source material]
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Why the most powerful club for journal editors must change
Published 16 July 2009
The Editor of the Journal of The Royal Society of Medicine (JRSM), Kamran Abassi, puts forward a strong call for change at The International Committee of Medical Journal Editors (ICMJE), a club formerly known as the Vancouver Group. Whilst recognising the valuable work they've done in the past, Kamran states; "The world, publishing, clinicians and patients have changed, and the ICMJE must change with them. The first question to answer is does this organization, at the summit of medical publishing, have any purpose?".
[Link to original source material]
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Resolving Unreported Conflicts of Interest
Published 8 July 2009
An Editorial in JAMA explains their revised approach for investigations into allegations of unreported potential conflicts of interest.
[Link to original source material]
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New group aims to detect misuse of statistics by government and media
Published 18 June 2009
Emily Pull reports in the BMJ, the news that a new group that aims to detect and highlight the misuse of statistics was launched on 18 June to help promote the public’s confidence in statistical information.
[Link to original source material]
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Reporting of sample size calculation in randomised controlled trials: review
Published 12 May 2009
The authors in this BMJ Research article conclude that sample size calculation is still inadequately reported, often erroneous, and based on assumptions that are frequently inaccurate. Such a situation raises questions about how sample size is calculated in randomised controlled trials.
[Link to original source material]
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Merck disguised "marketing publication" as medical journal to help promote Vioxx, court hears
Published 28 April 2009
More news in the BMJ written by Ray Moynihan from the ongoing trial in Australia where The Federal Court has heard allegations that the drug company Merck produced an entire medical journal as part of its marketing campaign to allay safety fears about Vioxx (rofecoxib), its cyclo-oxygenase-2 inhibitor, which was withdrawn in 2004.
[Link to original source material]
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Beleaguered Coast IRB calls it a day as clients jump ship
Published 27 April 2009
It is reported in PharmaTimes that Coast IRB, the Colorado-based institutional review board caught out in a sting operation by the US Government Accountability Office (GAO), has ceased all operations after losing the confidence of its client base.
[Link to original source material]
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How ethical are for-profit institutional review boards?
Published 25 April 2009
An Editorial in The Lancet notes that on April 14, the US Food and Drug Administration (FDA) sent a warning letter to Coast IRB of Colorado Springs, CO, a for-profit institutional review board (IRB), in which it outlined serious failings in the company's processes to approve research studies in human beings and states "commercial considerations must not be allowed to override thorough ethical approval processes".
[Link to original source material]
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Conflict of Interest, Disclosure, and Trial Reports
Published 8 April 2009
A personal account of the issue published in JAMA.
[Link to original source material]
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Court hears how drug giant Merck tried to "neutralise" and "discredit" doctors critical of Vioxx
Published 6 April 2009
Evidence in an Australian court case suggests that Merck attempted to 'neutralise' doctors unsupportive of Vioxx by offering money for research and other activities or intimidate others into silence. You can apparently see the some of the original documents at http://dida.library.ucsf.edu
[Link to original source material]
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A To-Do List for the New FDA Commissioner
Published 2 April 2009
NEJM article highlighting problems and recent incidents at the FDA, and suggesting actions the new commissioner may take.
[Link to original source material]
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JAMA’s new rule on whistleblowers creates controversy
Published 31 March 2009
BMJ article on the controversy caused when two doctors wrote to JAMA to point out non-disclosure of industry funding in a previously published JAMA article. This has developed into a full blown row with JAMA and raises a number of questions about how such whistleblowing should be handled.
[Link to original source material]
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The Lancet and advertorials
Published 21 March 2009
A letter published in The Lancet questions the integrity of a paper published in December's issue and states "No fewer than eight of the 12 authors, including the first and corresponding author, are employed by Merck, the funding sponsor of the study. Moreover, data were analysed and the process supervised by employees of Merck. Three employees drafted the first version of the manuscript. Three out of four authors not employed by Merck report receiving industry support." The authors respond in two letters, one from the industry authors and one from the academic authors.
[Link to original source material - initial letter]
[Link to original source material - response from the Academics]
[Link to original source material - response from the Industry]
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Harvard Medical School in Ethics Quandary
Published 2 March 2009
New York Times article on the anger of medical students who felt that their lecturer had provided biased information because of his relationship with industry.
[Link to original source material]
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Pharmaceuticals, patents, publicity…and philanthropy?
Published 28 February 2009
Lancet article on the GSK announcement promising to cut prices in developing countries and share research data on neglected diseases
[Link to original source material]
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Ethical and Scientific Implications of the Globalization of Clinical Research
Published 19 February 2009
In this NEJM article, the authors discuss the globalization of clinical research, highlight scientific and ethical concerns and propose steps for the harmonization of international clinical research.
[Link to original source material]
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Report: FDA Exerts Too Little Oversight of Researchers’ Conflicts of Interest
Published 18 February 2009
JAMA article describes a report by the US Department of Health and Human Services' Office of Inspector General criticising the FDA's investigations of conflict of interest.
[Link to original source material]
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GSK promises to cap price of its drugs in poorest countries
Published 18 February 2009
BMJ article on the GSK announcement promising to cut prices in developing countries and share research data on neglected diseases.
[Link to original source material]
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Drug giant GlaxoSmithKline pledges cheap medicine for world's poor
Published 13 February 2009
Article in The Guardian on the GSK commitment to cut prices in developing countries and share research data on neglected diseases.
[Link to original source material]
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Relation of study quality, concordance, take home message, funding, and impact in studies of influenza vaccines: systematic review
Published 12 February 2009
BMJ article reporting a systematic review of papers published on flu vaccines; it finds that higher quality studies are more likely to show concordance between the conclusions and the data presented, and that industry-funded studies are more likely to be published in high impact factor journals.
[Link to original source material]
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BMJ policy on trials of drugs and devices: advice to authors
Published 11 February 2009
Short BMJ article – the title says it all.
[Link to original source material]
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Doctors, patients and the drug industry
Published 5 February 2009
The Editor's Choice commentary in the BMJ gives a reasonably hopeful view of improvements in industry-doctor relationships following the report of the Royal
College of Physicians. See other articles published 3-4 February 2009.
[Link to original source material]
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Build bridges with the drug industry – but keep patients in mind
Published 4 February 2009
The President of the Royal College of Physicians (London) comments in this BMJ article on building relationships between the NHS, academic medicine and the pharma industry to improve innovation in healthcare. The article follows publication of the report: Innovating for Health: Patients, Physicians, the Pharmaceutical Industry and the NHS (report available here). Also see articles published in the BMJ on 3 February 2009.
[Link to original source material]
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Individual drug firms should stop paying for medical education
Published 4 February 2009
More from the BMJ following publication of the report from the Royal College of Physicians (London): Innovating for Health: Patients, Physicians, the Pharmaceutical Industry and the NHS (report available here). This article focuses mainly on pharma industry sponsorship of medical eduction. Also see other articles published in the BMJ on 3 and 4 February 2009.
[Link to original source material]
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Doctors, patients and the pharmaceutical industry
Relationships with the drug industry: More regulation, greater transparency
Relationships with the drug industry: Keep at arms length
Relationships with the drug industry: Collaboration to improve care
Relationships with the drug industry: Build trust based on good science
Relationships with the drug industry: Focus on better information
Published 3 February 2009
The BMJ publishes an editorial commenting on the report from the Royal College of Physicians (London): Innovating for Health: Patients, Physicians, the Pharmaceutical Industry and the NHS (report available here). The main objective of the report was to "identify policies that would promote . . . a relationship between the NHS, academic medicine and the pharmaceutical industry, the purpose of which is to discover and deliver safe, effective and affordable new medicines to patients based on need", an objective that was not achieved, according to the editorial. Accompanying letters from doctors and industry professionals provide a variety of views on how relationships between industry, doctors and patients should be conducted.
[Link to original source material (editorial)]
[Link to original source material (letter 1)]
[Link to original source material (letter 2)]
[Link to original source material (letter 3)]
[Link to original source material (letter 4)]
[Link to original source material (letter 5)]
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STREGA, STROBE, STARD, SQUIRE, MOOSE, PRISMA, GNOSIS, TREND, ORION, COREQ, QUOROM, REMARK... and CONSORT: for whom does the guideline toll?
Published 30 January 2009
This Journal of Clinical Epidemiology article describes the complexities of applying the various guidelines for reporting of clinical research.
[Link to original source material]
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EC, don’t let drug companies give information to the public EC proposal can be defeated
Published 20 January 2009
Two letters in the BMJ criticising EU proposals to allow pharma companies to provide some information on prescription drugs to patients.
[Link to original source material (letter 1)]
[Link to original source material (letter 2)]
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European red tape holds back UK research, say academics
Published 20 January 2009
Clinical academics express concern about the difficulties in obtaining approval for medical research in the UK.
[Link to original source material]
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Eli Lilly pays record $1.4bn for promoting off-label use of olanzapine
Published 20 January 2009
BMJ article on the record fine paid by Lilly for promotion of olanzapine for non-approved indications such as dementia, agitation, aggression, depression, and sleep problems, although it is only approved for schizophrenia and bipolar disorder.
[Link to original source material]
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Publication guidelines for quality improvement studies in health care: evolution of the SQUIRE project
Published 19 January 2009
This article describes the development of guidelines for publication of studies done in clinical setting to investigate improvements in the quality of healthcare.
[Link to original source material]
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Statistical question. Study design
Published 7 January 2009
Test your knowledge of study design with this BMJ article.
[Link to original source material]
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Helsinki discords: FDA, ethics, and international drug trials
Published 3 January 2009
Commentary in The Lancet on the FDA's decision that non-US clinical trials supporting applications for drug approval no longer need to comply with the Declaration of Helsinki.
[Link to original source material]
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Ethical considerations of publication planning in the pharmaceutical industry
Published December 2008
This article, published by Open Medicine, shows that many in academia are still not convinced that publication planning is an ethical and worthwhile activity.
[Link to original source material]
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Innovations in publishing BMJ research AND New format for BMJ research articles in print
Published 29 December 2008
These two articles describe new formats for abridged versions of research articles published in the BMJ: BMJ Pico (a new evidence abstract prepared by the authors of the research article) and a Short Cuts article written by BMJ staff.
Innovations in publishing BMJ research - [Link to original source material]
New format for BMJ research articles in print - [Link to original source material]
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Update on JAMA-EXPRESS
Published 24 December 2008
The Editors of JAMA provide an update on the policy and procedures of JAMA-EXPRESS (EXpedited Peer Review and Editorial System for Science), their fast-track review and publication process.
[Link to original source material]
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Commentary: The balance between marketing and safety
Published 24 December 2008
This BMJ article debates whether drug safety surveillance systems are up to the challenges posed by regulatory environments that allow more approval of new drugs.
[Link to original source material]
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Proposal to allow drug companies to give information to public sparks outcry
Published 16 December 2008
This BMJ article reports an angry reaction from various consumer and medical organisations to European Commission proposals to allow the pharma industry to provide information on prescription-only drugs to the public.
[Link to original source material]
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Breaking the embargo
Published 4 December 2008
Commentary from Fiona Godlee of the BMJ on the importance of observing media embargoes.
[Link to original source material]
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Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols
Published 4 December 2008
This BMJ article reports a study concluding that sample size calculations and statistical methods in randomised trials are often inadequately reported in protocols and publications, and that a high proportion of trials have discrepancies between information presented in the protocol and the publication.
[Link to original source material]
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What can we learn from drug marketing efficiency?
Published 2 December 2008
This BMJ article looks at how drug safety surveillance systems can be improved.
[Link to original source material]
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Improving the reporting of pragmatic trials: an extension of the CONSORT statement
Published 11 November 2008
A pragmatic trial is broadly defined as a randomised controlled trial whose purpose is to inform decisions about practice. The BMJ reports an extension of the CONSORT statement which is intended to improve reporting of pragmatic trials, focusing on helping practitioners to decide how applicable the trial is to their own practice.
[Link to original source material]
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Research methods and reporting
Published 22 October 2008
This article introduces a new section in the BMJ that will contain 'how to' articles on doing and writing up research. Articles for the new section should propose and explain practical and theoretical developments in research.
[Link to original source material]
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News Media Coverage of Medication Research. Reporting Pharmaceutical Company Funding and Use of Generic Medication Names
Published 1 October 2008
This JAMA article discusses how medical research is reported in the news media, and finds that pharma company funding of studies is often not stated by journalists.
[Link to original source material]
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Impact Assessment
Published September 2008
Written by Paul Chrisp and Kevin Thoale, and published in Pharmaceutical Marketing. As more and more scholarly materials appear on the web, the supremacy of tools like Medline and SCI impact factors is being challenged by new, less narrowly defined methods of judging merit. Diffusion or visibility of information (eg open access, Google Scholar) and its influence or quality (eg F1000 factor, SJR) are the key issues for publication planning. It is possible that these elements could be combined to define a ‘digital footprint’ or ‘digital impact index’ (DI2) that determines the true ability of a publication to influence adoption of a new drug.
[Link to original source material]
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Gratis and libre open access
Published 2 August 2008
The SPARC (Scholarly Publishing and Academic Resources Coalition) Open Access Newsletter discusses the confusion sometimes associated with the term 'open access'. The article suggests terminology to distinguish between content that is free of charge ('gratis') and content that free of usage restrictions ('libre'). There are other interesting snippets in the rest of the newsletter.
[Link to original source material]
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Pharmaceutical promotion and First Amendment rights
Published 31 July 2008 (NEJM)
FDA oversight of drug company promotion of off-label use is poor, US watchdog says
Published 5 August 2008 (BMJ)
A letter in the NEJM defends publications discussing off-label use of pharmaceuticals. The same issue is discussed in the BMJ.
[Link to original source material (NEJM)]
[Link to original source material (BMJ)]
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Open access publishing, article downloads, and citations: randomised controlled trial
Editorial: Open access to research
Published 31 July 2008
The BMJ reports a randomised trial comparing usage and citation rates generated by open access models compared with subscription models. Fiona Godlee of the BMJ provides editorial comment.
[Link to original source material (trial report)]
[Link to original source material (Godlee)]
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SWEN – when authors disagree
Published 26 July 2008
This article describes how The Lancet has dealt with a recent dispute amongst authors of a paper about how the data were interpreted.
[Link to original source material]
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Successful publication planning – strategy, ethics and rules of engagement
Published 12 June 2008
A summary by Mary Greenacre of the MedCommsNetworking seminar in London, sponsored by Wolters Kluwer Health.
[Link to original source material]
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Peer review in the balance
Published 22 May 2008
This article in the NEJM discusses the Pfizer court case to require the journal to provide peer review comments on all manuscripts covering Pfizer's COX-2 inhibitors.
[Link to original source material]
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Online and on-message
Published April 2008
Article by Matt McKay of BioMed Central on the role of online journals in publication planning. Published in Pharmaceutical Executive Europe.
[Link to original source material]
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Strategies and solutions for publication planning and execution excellence
Published 11 September 2007
An in-depth report from The International Publication Planning Association’s 5th Annual Meeting held in San Francisco, CA, 25-26 June 2007 by Elizabeth Wager. Published in the KeywordPharma Conference Insights series, the full report is available to download free of charge, sponsored by Wolters Kluwer.
[Link to original source material]
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