TVF Communications Navigate the Age of Transparency in Medical Publications
Last week, the industrious and dynamic TVF Communications writing team briefly took some respite from their heavy workload and headed over to the 2016 European meeting of the International Society for Medical Publication Professionals (ISMPP). Along with other ISMPP members the team had a chance to pause, reflect and gaze into the future of the medical publications industry. As the culture of medical publications planning moves towards increasing transparency, we at TVF Communications are acutely aware that our present moment is one of the most open in terms of the sharing of clinical data – more so than at any point history.
Of course, this shift towards increased transparency in medical publications planning comes with a host of challenges, discussed at this year’s European meeting of the ISMPP by Andy Powrie-Smith, Director of Communications for EFPIA. Speaking of the “cultural change” required, Powrie-Smith urged healthcare communications agencies to act positively in support of this change to develop their own data policies, a theme that was continued in a panel discussion on the 3rd edition of the Good Publication Practice Guidelines (GPP3).
The GPP3 guidelines were published in August, and for this session members were invited to a Q&A with a panel consisting of some authors of the guidelines, journal editors and medical publication managers from the pharmaceutical industry. One of the authors of the guidelines, Dan Bridges, encouraged interpretation of the ‘grey areas’ in the spirit of the overall guidelines, stating it would be impossible to cover all the scenarios in a single guideline and that the GPP3 guidelines were to offer a guide and general ethos that should be applied to situations with the overall aim of achieving the greatest professionalism and transparency possible.
Other topics of discussion included how pharmaceutical companies and medical publication planning specialists are addressing the increase in data disclosure and the publishing of results and documentation of trials in public repositories. Fergus Sweeney, Head of the Inspections & Human Medicines Pharmacovigilance Division at the European Medicines Association (EMA), gave an overview of new EMA policies on data sharing and the disclosure of trial data. From January 2015, all new marketing authorisation applications for new or existing medicines will have copies of their clinical study reports (CSRs) published on-line once the marketing authorisation is granted. Access will be two-tiered, the public will be able to read the CSRs online only and researchers will be able to apply for a more in-depth level of access. The panel also discussed the challenge of granting access to patient level data, which must balance the value of data availability with the importance of protecting patient identity – an area of on-going development for pharmaceutical companies.
So, it’s back to the office with renewed vigour for writing the publications of the future!
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