Author: Jo Chapman, PhD (Aspire Scientific Ltd)
Over two days last week, around 250 delegates and exhibitors braved sub-zero temperatures to attend the European meeting of the International Society for Medical Publication Professionals (ISMPP) in London. The agenda was centred around publication planning in the era of data sharing and transparency and included a keynote address, lively panel discussions, smaller roundtable case-study reports and interactive parallel sessions. The Publication Plan will post summaries of the plenary and poster presentations from the meeting for those of you that could not attend, as well as acting as a timely reminder of the highlights for those that did.
A summary of the first day of the meeting is provided below. A summary of the second day of the meeting can be found here.
Day 1: Tuesday 19th January 2016
2015: A year in review
After a welcome from Fiona Plunkett, Chair for the European Meeting Programme Committee, Iain Hrynaszkiewicz from Springer Nature delivered a valuable account of medical publication key issues and events from 2015. The year marked the 350th anniversary of the first scientific journal, Philosophical Transactions of the Royal Society, which started systematically reporting research results and thus initiating the era of medical publishing. Three hundred and fifty years later, publications are still growing strong.
Iain mentioned that the recurring topics in 2015 included transparency, data sharing, open-access, publication bias and trust. Although the concept of total trial data reporting – both positive and negative – is considered essential, Iain reminded us that publication bias is still a problem. To demonstrate this, Iain referred to a report by Roest and colleagues that discussed reporting bias in clinical trials investigating the efficacy of second-generation anti-depressants for treating patients with anxiety. Roest concluded that reporting bias has led to an increase in the number of positive reports in the literature regarding the efficacy of these drugs in these patients. One initiative aimed at increasing access to trial data and making it easier to identify trials that have not published results was heralded by Open Knowledge in April last year. OpenTrials (http://opentrials.net/) is a freely-accessible, online database bringing data and trial-related documents together in one place.
Iain went on to outline how the peer review process came under scrutiny last year when Springer retracted 64 articles from 10 journals and Biomed Central retracted 43 articles after discovering incidents of “fake peer review” by “fabricated reviewers”.
Iain also discussed the worrying phenomenon of predatory publishing. Around 420,000 articles were published in such journals in 2014. These journals abuse the open-access model and generally provide no peer review or editing of the paper. Investigators are encouraged to use the “think, check, submit” check list when deciding on a journal for their paper (http://thinkchecksubmit.org/). On a more positive note, a new journal focussing on “research into supporting, encouraging or delivering the patient/public voice in research processes or structures” was launched last year – Research Involvement and Engagement. http://thinkchecksubmit.org/In August, the long-anticipated release of Good Publication Practice 3 (GPP3) was a welcome event that affected everyone in the medical publishing profession.
GPP3: Member-proposed case studies and panel discussion
This was a very popular session based around the updated GPP3 guidelines published in August 2015 and questions submitted via an ISMPP survey circulated prior to the meeting. The faculty included Dr Dan Bridges (Regional Director-Europe, Nucleus Global, UK), Professor Ana Marušić (Professor of Anatomy, University of Split and editor-in-chief of Journal of Global Health, Croatia), Dr Elizabeth Wager (Publications consultant, Sideview, UK) and Dr Nicole Rapior (Head of Global Scientific Publications, Boehringer Ingelheim Pharma GmbH & Co, Germany). With the importance of GPP3 firmly established within the medical writing community it was perhaps a surprise to hear that only about 30% of editors are aware of its existence. One of the key objectives as GPP evolves is to ensure more input from editors in future updates. Promotion of GPP within academia is also seen as an important objective.
The first issue for the panel was on the subject of authorship. It was agreed that all authors should be included in the kick-off call(s) and have input to the publication throughout the whole process, from outline to final version. The need for authorship transparency is paramount. Guidance for authorship criteria has been provided in GPP3 and by the International Committee of Medical Journal Editors (ICMJE). Education is needed to reassure readers that the inclusion of authors from industry does not mean bias. Payment of authors was also discussed, as the new guidelines provide further information on this topic.
With a push on data sharing and transparency, it was highlighted that patient anonymity is vital but more could be done to allow open data sharing, such as including the necessary patient permissions within study consent forms. There was an interesting debate around whether self-plagiarism can ever be acceptable. There was general consensus that, for example, in methodology, if the descriptions are well-defined, then perhaps they do not need to be rewritten in subsequent papers with the chance of making them less precise. It was suggested that with the availability of a range of tools to check for plagiarism, some journals may have become hypersensitive to the problem.
The GPP3 guidelines are a fantastic resource for everyone involved with medical publishing, and with translations into Spanish, Mandarin and Japanese underway and the introduction of ISMPP Asia meetings last year, global spread of best practice is underway.
Real world evidence and publications
Richard White, Commercial Director at Oxford PharmaGenesis Ltd, spoke about the importance of publishing real world evidence (RWE). Richard described meta-analyses of randomised controlled trials (RCTs) as the “shining light” and that RWE, such as observational studies, are perceived to be less important. However, RWE is a measure of the effectiveness of a drug as opposed to its efficacy in a defined population such as that measured in a RCT. In fact, both sets of data complement each other. RWE can give an indication of how healthcare professionals and patients use the drugs day-to-day when not constrained by trial protocols. Richard acknowledged that a majority of readers consider the quality of RWE as less robust than RCT results, and that further education and communication around RWE is needed.
Richard went on to describe some key areas that may help in boosting the credibility of RWE studies. Articles must fully explain the methods employed to minimise bias and confounding, as the lack of randomisation and risk of bias can be seen as a problem. The choice of data source, whether it be a claims database, disease registry or electronic health records should be justified. It is essential that the patient population investigated provides a reasonable representation of what is being measured. There is concern that although a large number of RWE studies are undertaken, only positive data is published. The same rigour that has been implemented in the publication of RCTs must be adopted by RWE studies. Appropriate guidelines including STROBE (http://www.strobe-statement.org/), PRISMA (http://www.prisma-statement.org/) and MOOSE (http://www.ncbi.nlm.nih.gov/pubmed/10789670) should be followed in the reporting, and limitations should be acknowledged. Transparency is key: transparency in methodology, transparency in strategy and transparency in reporting.
Data and financial transparency reporting
For this session the faculty included Dr Slavka Baronikova (Publications Lead, Shire, Belgium), Professor Ana Marušić (Professor of Anatomy, University of Split and editor-in-chief of Journal of Global Health, Croatia), Andy Powrie-Smith (Director of Communications, EFPIA), Laurence Rouxhet (Head of Publications Management and Web Disclosures, GSK Biologicals, Belgium) and Fergus Sweeney (Head of Inspections and Human Medicines Pharmacovigilence Division, EMA).
Fergus Sweeney began the session with an overview of the policies adopted by the European Medicines Agency (EMA) for transparency, including Policy 70 which came into force on 1 January 2015. Under this policy, the agency proactively publishes clinical reports submitted as part of marketing-authorisation applications for human medicines. The policy is undergoing stepwise implementation, with the first reports becoming available from September 2016. There will be two sets of terms-of-use, with common elements such as the protection of patient identity and prevention of unfair commercial use. A review of various issues concerning the disclosure of individual patient data is set to follow.
Andy Powrie-Smith continued the session with the European Federation of Pharmaceutical Industries and Associations (EFPIA) perspective. EFPIA believes that clinical trial data sharing is in the best interest of patients, clinicians, medical research and the pharmaceutical industry. Together with the Pharmaceutical Research and Manufacturers of America (PhRMA) they have developed five principles for responsible data sharing.
Andy also outlined the EFPIA disclosure code which requires pharmaceutical companies that are members of EFPIA or of an EFPIA member association to track and publicly disclose payments and other transfers of value made to healthcare professionals and healthcare organisations in certain categories. This came into effect at the beginning of 2015 and is currently operating in 33 European countries. Andy discussed the tension between transparency and privacy and argued that we need a change in culture to enable transparency to become the norm.
Laurence Rouxhet went on to describe the disclosure policies at GSK, including their commitment to providing access to anonymised patient-level data. Researchers can request access to clinical data via the Clinical Study Requests website. A scientific rationale is required, and researchers are invited to submit a proposal including an aim to publish. If approved, access is granted to a secure site for a limited length of time. To date, 13 pharmaceutical companies have committed to use the Clinical Study Requests website. The challenge of maintaining consistency between reporting websites was discussed, and a closer collaboration between publication and disclosure teams was advocated.
Finally, Dr Slavka Baronikova spoke about Shire’s publication approach. Shire follows the Principles for Responsible Clinical Trial Data Sharing (EFPIA and PhRMA) and EMA regulations. All interventional and non-interventional sponsored trials conducted in humans are registered on ClinicalTrials.gov, and public access to clinical studies is provided via www.shiretrials.com. Researchers wishing to gain access to patient-level data can do so through a secure website following acceptance of a proposal. Shire ensures lay summaries are available to patients within one year of study completion.
The faculty concluded the session with discussions around the changing face of publications, emphasising the need to ensure consistency between registries and publications, and debated the issues relating to transfer-of-value with respect to medical writing. No firm conclusion was made on this, although Andy Powrie-Smith stated that no company would be penalised for disclosing too much.
Day 1 ended with a networking reception allowing time for delegates to view the posters presented by ISMPP members.
By Jo Chapman, PhD (Aspire Scientific Ltd)
Aspire Scientific is a boutique medical writing and publication planning agency led by professionals with at least a decade of medical writing experience and supported by PhD-educated writers and academics at the forefront of their specialist fields.