With a company stand and a high level of participation in the programme, Oxford PharmaGenesis made a significant contribution to the European Meeting of the International Society for Medical Publication Professionals (ISMPP) held in London last week.
Review of the year
Along with the UK’s Brexit vote and the USA presidential election, Martin Delahunty (Nature Partner Journals) noted that other developments in the past year that are likely to have an impact on medical communications include the International Committee of Medical Journal Editors (ICMJE) proposal regarding patent-level data (see below) and the publication of research undertaken by Oxford PharmaGenesis which demonstrates that professional medical writing support improves the quality of clinical trial reporting.
The ISMPP EU meeting this year coincided with the publication of the American Medical Writers Association (AMWA), European Medical Writers Association (EMWA) and ISMPP Joint Position Statement on the Role of Professional Medical Writers (co-authored by Chris Winchester of Oxford PharmaGenesis).
Clinical trial reporting
There was a lively discussion about the ICMJE proposal that availability of patient-level data should be a requirement when publishing clinical trial data. Proponents Fiona Goodlee (British Medical Journal [BMJ]) and Chris Carrigan (Public Health England) argued that such availability would increase public trust in reported clinical trial data, and that examination of these data might lead to patient benefits. Among the potential causes for concern expressed by Philip Devereaux (McMaster University, Ontario, Canada) and Slavka Baronikova (Shire) were compromised patient privacy, delayed publication of trial results and spurious secondary analyses of trial data.
There was broad agreement that pharmaceutical companies should make ‘good faith efforts’ to publish aggregate data from clinical trials, and aim for submission no more than 12–18 months after the data become available. All of the companies represented at the meeting committed to posting clinical trial data on their public websites.
In his keynote address, Carl Heneghan (Centre for Evidence-Based Medicine, Oxford) contended that the reporting of clinical trials is typically far from optimal, and that professional medical writers have a responsibility to improve this situation.
In a light-hearted ‘trial-by-jury’ session, there was agreement among the ‘jury’ that the current evidence does not support the suggestion that ‘50% of trials are not reported’. On the other hand, the ‘jury’ thought that more evidence was required before the notion that medical writers introduce bias into clinical trial reporting could be entirely debunked.
Extending the reach of publications
Paul Lane (Envision Pharma) described the use of social media monitoring tools such as Sysomos, Crimson Hexagon and Fig Leaf to gain insight into the reach of current publication practices. Jürgen Wiehn (Shire), with support from Oxford PharmaGenesis, described an alternative, focused, approach in which (a) the reach of Shire papers published during the second half of 2016 was estimated using several different metrics and (b) the number of congress delegates accessing electronic copies of posters from the Shire Congress Posters website via QR codes was assessed.
Richard White and Julie Beeso from Oxford PharmaGenesis demystified patient-reported outcomes (PROs) by explaining the concepts of content validity, reliability (e.g. internal consistency and test–retest coefficient), responsiveness and construct validity. Delegates were urged to follow appropriate guidelines such as the Consolidated Standards of Reporting Trials (CONSORT) PRO and those published by the International Society for Quality of Life Research (ISOQOL). Other parallel sessions of interest focused on scientific communication platforms, data transparency, transfer of value, population-based registries and the challenges of planning publications faced by smaller pharmaceutical/biotechnology companies.
Together with our partners, Oxford PharmaGenesis presented the following posters at the meeting.
- Commitments to data sharing by pharmaceutical companies: the evolving environment.
Slavka Baronikova, Jim Purvis, Andrew Desson, Julie Beeso, Eric Southam, Christopher Winchester and Antonia Panayi
- Identifying real-world evidence data sources in peer-reviewed publications: planning the Assessing Peripheral Artery Disease in Clinical Practice (APHELIA) study.
Saga Johansson, Pål Hasvold, Mogens Westergaard, Christopher Winchester and John P Bell
- A systematic approach to journal selection with the aim of improving acceptance rates of real-world evidence publications.
Laura Schmidt, Lars Elvelin, Paul Farrow, Catriona Hansbauer, Saga Johansson and Helene Rosvall
- Surveying the evolving models of digital publishing: where does pharma fit?
Amy Williams, Christopher Winchester, Lucy Robinson, Tim Koder, Christopher Rains and Richard Smith