Embracing Change in Medical Publishing: The Open Pharma Project

Chris Winchester, DPhil, Oxford PharmaGenesis, Oxford, UK

Do pharmaceutical companies have a role in helping advance the publication of science? This was the question posed by Richard Smith, Former Editor of The BMJ and now Chairman for the Board of Directors of Patients Know Best, at an international meeting held at the Wellcome Trust in London earlier this year (Figure 1).¹ The answer from the academics, journal editors, publishers, patients, regulators, industry professionals, and research funders who took part in the meeting was a resounding “yes.”

Figure 1. Stakeholders at an international meeting on the role of pharmaceutical companies in medical publishing held at the Wellcome Trust in London, January 2017.

What began as a listening exercise has evolved into a set of multidisciplinary workstreams under the umbrella “Open Pharma.” These workstreams are exploring four specific aspects of the wider Open Science movement (Figure 2) that are relevant to the pharmaceutical industry:

• Open access publishing
• Systems for identifying people and their roles in the publishing process, such as ORCID, Convey, and CRediT
• Preprints
• The concept of a layered publication model, in which information about a clinical trial is made available in layers appropriate to different audiences

Figure 2. Open Science priorities. Reproduced with permission from the Directorate-General for Research and Innovation, European Commission.

Open Access

Governmental and charitable funding bodies, such as the Bill & Melinda Gates Foundation, Wellcome Trust, and Research Councils UK, now require that all the research they fund must be published open access. Pharmaceutical companies, which fund approximately half of all medical research,² are increasingly encouraging authors to publish open access, but they tend to not have their own open access policies,³ and are typically not granted the same terms as non-commercial research bodies. Indeed, some journal publishers will not allow pharmaceutical companies to purchase an open access option at all. How should pharmaceutical companies respond to increasing societal pressure for open access to research, particularly research conducted in human subjects? In order to embrace a more open publication model, should they join other research funders and require the research they fund to be published open access? These are questions on which Open Pharma aims to provide practical advice and promote discussion with the scientific community.

ORCID, Convey, and CRediT

Open Pharma is focused on innovations that aim to increase the transparency and speed of publishing. For example, some journals now require, and others allow, authors to have an Open Researcher and Contributor ID (ORCID), which is a persistent digital identifier that is automatically linked to authors’ publication records.^{4, 5} ORCID has the potential to introduce simplicity and consistency to the author conflicts of interest disclosure process, via Convey, from the Association of American Medical Colleges.⁶ There are also moves to classify the contributions of authors and researchers to published research with the help of CRediT (Contributor Roles Taxonomy), a project that aims to improve author attribution, credit, and accountability through the use of a taxonomy of different contributions. Open Pharma is assessing the potential impact that the adoption of these systems could have on making medical publishing by the pharmaceutical industry more open.

Preprints

Publishing the pre-peer-reviewed version of a manuscript on a preprint server is a widely accepted practice in many fields of science, and is gaining acceptance in biology.^7,8 At the recent International Congress on Peer Review and Scientific Publication, September 10-12, 2017, in Chicago, Harlan Krumholz, a cardiologist from Yale University and Yale-New Haven Hospital, joined the calls for preprints in medicine.^{8, 9} He introduced MedArXiv, a dedicated preprint server for medical research that will be launched soon.¹⁰  

Preprints can increase the speed and transparency of research by providing openly available up-to-date data on a study, and benefit from being permanent public documents that are linked to a citable digital object identifier.¹¹ From discussions within Open Pharma meetings, it is apparent that most journals publish articles that have already been disclosed as preprints, and regulators are likely to consider the use of preprints as “scientific exchange” rather than off-label promotion or promotion to patients. However, pharmaceutical companies have legitimate concerns about the implications of publishing data outside the “safe harbor” of peer review, which need careful consideration.

Layered Publication Model and Post-Publication Peer Review

Open Pharma is considering the potential of a layered publication platform, on which all materials relating to a clinical trial (eg, research proposals, published abstracts, clinical study reports, peer-review comments) could be hosted, to increase the openness of medical research. There are two main ways of achieving this model:

1. Cross-reference existing data and publications using established platforms, such as Crossref or OpenTrials.
2. Create a new platform for the management of publications and peer review with layers for different audiences, including clinicians, academics, systematic reviewers, payers, and patients.

Post-publication peer review is a process in which transparent peer review occurs after publication.¹² Platforms that support open post-publication peer review, such as F1000Research, are becoming more commonly used, and effectively provide the option for authors to publish manuscripts as preprints that are subsequently peer-reviewed in an open forum and indexed once peer review has been completed. Collaboration between pharmaceutical companies and digital platforms has the potential to improve the dissemination of medical research.¹³

Over the coming months, experts involved in the Open Pharma initiative aim to provide practical advice for pharmaceutical companies, publishers, and other stakeholders to advance the publishing of science. Open Pharma will be discussed in a 90-minute panel session entitled “Time to Embrace Change in Medical Publishing?” at the upcoming European Meeting of ISMPP, January 23-24, 2018, in London. Latest news and views related to the Open Pharma project can be found on the Open Pharma Twitter page and blog.

Disclosures

Chris Winchester is Managing Director of Oxford PharmaGenesis and Chair-Elect of ISMPP Board of Trustees. Oxford PharmaGenesis provides the secretariat for the Open Pharma initiative.

Acknowledgements

The author thanks the publishers, research funders, pharmaceutical companies, journal editors, academics, and regulators involved in the Open Pharma initiative. Writing support for this article was provided by Tim Ellison, PhD, of PharmaGenesis London, London, UK.

References

1. Smith R. Time for pharmaceutical companies to help improve the publishing of science. The BMJ Opinion, 2017. Available from: https://blogs.bmj.com/bmj/2017/01/31/richard-smith-time-for-pharmaceutical-companies-to-help-improve-the-publishing-of-science/ (Accessed 10 October 2017).
2. Dorsey ER, de Roulet J, Thompson JP et al. Funding of US Biomedical Research, 2003–2008. JAMA 2010; 303(2):137–143. doi:10.1001/jama.2009.1987.
3. Collins E. Publishing priorities of biomedical research funders. BMJ Open 2013; 3; e004171. doi: 10.1136/bmjopen‑2013‑004171.
4. Marchington J, Panayi A, Baronikova S et al. Open access licences: what drives publisher options? Curr Med Res Opin 2017; 33(Suppl 1):26. Available from: http://www.caudex.com/downloads/OA_survey_EU_ISMPP_2017_poster_15.pdf (Accessed 10 October 2017)
5. Meadows A. Why some publishers are requiring ORCID iDs for authors: an interview with Stuart Taylor, The Royal Society. The Scholarly Kitchen, 2016. Available from: https://scholarlykitchen.sspnet.org/2016/01/07/why-some-publishers-are-requiring-orcid-ids-for-authors-an-interview-with-stuart-taylor-the-royal-society/ (Accessed 10 October 2017).
6. Mann S. Convey: a new system to simplify the process for disclosing financial interests. AAMC News, 2016. Available from: https://news.aamc.org/research/article/convey-new-system-simplify-process-disclosing-fina/ (Accessed 10 October 2017).
7. Bhalla N. Has the time come for preprints in biology? Mol Biol Cell 2016; 27: 1185–1187.
8. Husten L. Prepublish or perish? Making a case for medicine to take a cue from basic science. Cardio Brief, 2015. Available from: http://cardiobrief.org/2015/12/17/prepublish-or-perish-making-a-case-for-medicine-to-take-a-cue-from-basic-science/ (Accessed 10 October 2017).
9. Lauer MS. Time for prepublication culture in clinical research? Lancet 2015; 386:2447–9.
10. Krumholz H. Preprints and other threats to traditional publishing. Eighth International Congress on Peer Review and Scientific Publication. Peer Review Congress, 2017. Available from: https://www.youtube.com/watch?v=WGN1Rg765AM (Accessed 10 October 2017).
11. ASAPbio. Preprint FAQ. Available from: http://asapbio.org/preprint-info/preprint-faq (Accessed 10 October 2017).
12. Tattersall A. Comment, discuss, review: An essential guide to post-publication review sites. LSE Impact Blog, 2014. Available from: https://blogs.lse.ac.uk/impactofsocialsciences/2014/11/08/comment-discuss-review-an-essential-guide/ (Accessed 27 January 2017).
13. Williams A, Winchester C, Robinson L et al. Surveying the evolving models of digital publishing: where does pharma fit? Curr Med Res Opin 2017; 33(Suppl 1):29. Available from: http://www.healthsciencelive.com/uploads/UK/987041_Surveying_the_evolving_models_of_digital_publishing:_where_does_pharma_fit.pdf (Accessed 10 October 2017).