Reflections and predictions at the turn of the year

Alison Chisholm

Janus was the forward-and-backward-looking god of beginnings and endings, and the namesake of January. Inspired by Janus, we’re taking a moment in this first month of the year to look back at the Open Pharma highlights of 2022 and to what lies ahead in 2023.

Accessible summaries: a winter of this content

The year began with an accessibility bang. In January 2022, Ipsen announced a new commitment to publishing plain language summaries (PLS) with all of their journal publications that contain human data. This landmark PLS mandate follows Ipsen’s open access mandate for scientific research publications (announced in 2019) and highlights an ongoing commitment to strengthening trust and transparency between medical professionals and the public.

The growing momentum in PLS for industry-funded publications builds on the previously established regulatory lay language summaries of clinical trial results for non-specialist audiences. The Center for Information and Study on Clinical Research Participation (CISCRP), a major non-profit supplier of lay summaries, published their 2021 Perceptions & Insights Study in January 2022. Included in the report was the finding that 89% of respondents agreed that it is important for sponsors to share clinical trial results to participants in easy-to-understand language.

A spring congress circuit with a focus on PLS

The accessible summary activity continued into the spring of 2022. In May, the lead author of the Open Pharma PLS recommendations,1 Adeline Rosenberg, spoke at a plenary session at the 19th Annual Meeting of International Society for Medical Publication Professionals (ISMPP). In addition to a discussion of key quality considerations for PLS, the session covered the ‘What, Who, When and Where’ of PLS – what they are; who writes, reviews and reads them; when they should be developed; and where they can be found and accessed.

Also in May, Slávka Baróniková (Scientific Publications Lead at Galapagos) facilitated a PLS workshop at the European Medical Writers Association Annual Symposium in Berlin, and Valérie Philippon (then Head of Global Publications at Takeda, now Global Head of Scientific Communications & Managed Access, Rare Diseases Organization at UCB) represented the Open Pharma PLS recommendations at the Council of Science Editors Annual Meeting in Phoenix, Arizona, USA. Valérie spoke of the role that PLS play in improving access to scientific advancements, their value in improving research engagement and impact, and their benefits for different stakeholder groups (patients, healthcare professionals, policymakers and the media).

A strategic summer for Open Pharma

Central to the Open Pharma calendar in 2022 was the virtual roundtable meeting held at the Pharma and Publishers Forum on 24 June 2022. Chaired by Caroline Sutton (Chief Executive Officer of STM Publishing) and Richard Smith (Former Editor of the BMJ and Chief Executive of the BMJ Publishing Group), roundtable participants from the publishing and pharmaceutical sectors discussed unmet needs in key topic areas within open science (see Table).

Open science topicIdentified need
PLS• Establish methods for evaluating how much easier it is for non-expert audiences to find and understand publications when these are accompanied by PLS
• Develop practice and quality standards for PLS
• Explore ways of reducing the extra work that PLS represent to publishers
Open access• Improve author appreciation of the value of open access publishing; reduce the traditional author focus on journal impact factor or citation score
• Simplify, or educate authors on, open access licensing agreements
• Explore issues of open access publication bias associated with article processing charges, and possible solutions
Discoverability • Explore search engine optimization for research outputs so that scientific data reaches a wider range of audiences
• Explore the use of article-level metrics for assessing publication impact
Data sharing • Educate authors on optimal data sharing practices
• Harmonize pharma and publisher perspectives on preferred data storage platforms
• Explore the benefit of developing a universal data sharing guideline, including guidance around implications of:
– different data protection regulations among countries
– disparities between pharma and publisher policies on data sharing

Building trust in the autumn

September 2022 saw Chris Winchester (CEO of Oxford PharmaGenesis) and Slávka Baróniková (Scientific Publications Lead at Galapagos) presenting the Open Pharma research on prevalence and temporal trends in PLS indexing at the 9th International Congress on Peer Review and Scientific Publication in Chicago, Michigan, USA.

Later in the month, Open Pharma held its first public event since the COVID-19 pandemic: the Satellite Symposium at the Association of Learned and Professional Society Publishers Annual Conference and Awards 2022. In the session Who can we trust? Open science and pharma research, presenters and audience members from pharmaceutical, publishing, medical communications and patient advocacy backgrounds discussed the role of open science in building trust in pharma research, with a focus on open access publishing and accessible summaries.

A video of the symposium is still available on YouTube and a meeting report2 was published in a special issue of Medical Writing on the topic of Open Science and Open Pharma.

Closing the year with a focus on patient authorship

One of the final Open Pharma events of 2022 was a Members’ topic meeting on patient authorship, reflecting growing patient involvement in research and research publications. With the 2022 updates to the Good Publication Practice 2022 guidelines just published, our group examined the new recommendations section on the role of patients in biomedical publications.3

The session speakers led a stimulating discussion and offered valuable insights about new publication formats that encourage patient involvement, how patient authors can (and often do) fulfil International Committee of Medical Journal Editors criteria for authorship, and how to balance fair reimbursement with potential for bias or perceptions of bias.

Guest blog highlights in 2022
How pharma will help move the needle on open research, Mark Hahnel (CEO and Founder of figshare)
Perceptions and insights on clinical trial participation: results from the 2021 CISCRP study, Jessica Cronin (CISCRP)
Open science: reflecting upon real-world impact [podcasts], Martin Delahunty (Founder and Managing Director of Inspiring STEM Consulting)

2023 … what lies ahead?

There’s lots to be excited about in open science for pharma in 2023, starting with a strong Open Pharma presence at the 2023 European Meeting of ISMPP, which includes a roundtable titled Much ado about access.

Research access and accessibility look set to be ongoing themes for the coming year.

Open Pharma will be launching a new and extended open access benchmarking model in 2023. The keenly awaited tool will build on our previous informatics analyses of open access publishing rates among pharma companies.5,6 Another topic expected to be of growing interest in 2023 is that of sustainability, particularly given that Open for climate justice was selected as the theme for Open Access Week last year. We anticipate a strengthening of links between the open science community and sustainability issues over the course of the year.  

In the accessibility space, there have long been assertions that patients are a valid audience for pharma research, but recognition and acceptance of this are now gathering pace. Within this context, Adis and Taylor & Francis have recently launched long-form, peer-reviewed stand-alone PLS publications. With further initiatives of this kind anticipated, there is also a growing need for clear distinctions to be made between different accessible summary formats, as discussed by Griffiths et al. in Medical Writing.4 We also anticipate some interesting developments around the establishment of PLS repositories and third-party platforms with the potential to make accessible summary formats more discoverable and navigable.  

Finally, as we stand like Janus at the gateway to the new year, we may be on the verge of a new epoch for pharma publishing. If correct, Paul Simms’ (Chief Executive of Impatient Health) predictions of a 20% reduction in commercial head count across the pharma industry in 2023 would position credible science sharing as a major driver of business success; exciting times indeed for open science.

References

  1. Rosenberg A, Baróniková S, Feighery L et al. Open Pharma recommendations for plain language summaries of peer-reviewed medical journal publications. Curr Med Res Opin 2021;37:2015–6. doi: https://doi.org/10.1080/03007995.2021.1971185.
  2. Chisholm A. Can access and accessibility rebuild public trust in research? Medical Writing 2022;31:13–5. doi: https://doi.org/10.56012/wzoz4567.
  3. DeTora LM, Toroser D, Sykes A et al. Good Publication Practice (GPP) guidelines for company-sponsored biomedical research: 2022 update. Ann Intern Med 2022;175:1298–304.
  4. Griffiths S, Appiah A, Rosenberg A et al. Landscaping the terminology of accessible language document types. Medical Writing 2022;31:24–30. doi: https://doi.org/10.56012/cbxl1493.
  5. Macdonald S, Koder T on behalf of Open Pharma. How open are pharma publications? [poster]. Presented at the 2020 European Meeting of ISMPP, 21–22 January 2020, London, UK.
  6. Freeman H et al. on behalf of Open Pharma. How openly accessible pharma-sponsored research? An informatics approach [poster]. Presented at the 2021 Virtual European Meeting of ISMPP, 26–27 January 2021.
  7. Smith R. Do patients need to read research? BMJ 2003;326:1307. doi: https://doi.org/10.1136/bmj.326.7402.1307