Making sense of clinical trials for investors and the wider public through clear, concise, compelling stories

Photo by Ani Kolleshi on Unsplash

Abstract

New digital streams of content are emerging designed to increase the visibility of research and increase the download rate for research papers. This content goes beyond the standard clinical research and review papers, it includes lay summaries, infographics, podcasts, videos, and author interviews aimed at wider audiences. In fact, per European Union (EU) regulations, lay summaries are now mandatory for clinical research papers. To create such content, new online editing, monitoring and collaborative tools are being developed, such as SciencePOD. These web technologies are changing the way medical writers work and collaborate. At the click of a button, biopharma companies can now avail of the best medical writers around the world who collaborate on the virtual platform developed  by SciencePOD in producing content. And the type of content that is being created—in an accessible language—contributes to make the latest progress in medical research accessible to wider audiences.

Availing of web technologies, changes the nature of collaboration in the delivery of medical writing and lay summaries

As often happens in medical writing circles, new practices are born from regulations. Specifically, the European Union (EU) regulation (536/2014)on clinical trials on medicinal products for human use, implemented since 2015, introduced the greatest transparency requirements ever. It mandates that all sponsors of clinical studies make the study results available, not only as a scientific summary but also as a summary “that is understandable for laypersons.” From the end of 2018, the European Medicines Agency will publish clinical reports, scientific abstracts, and lay summaries in a single location on its EU-portal.

Going one step further, the European Commission saw the need to provide further guidance beyond the regulation as to what was meant by lay summaries in this instance. This led to the development of the ‘Summary of Clinical Trial Results for Laypersons’guidelines recently developed by the UK Health Research Association (HRA) guide for the Commission. What this means is that medical writers may have the opportunity to become involved in the delivery of such lay summaries, which require different writing skills than those for regular medical writing.

Open science

The introduction of lay summaries for clinical research is fully aligned with wider trends, where there is a push towards a more open science. This means that clinicians and researchers are encouraged to get out of their own silos and collaborate increasingly across disciplines. The ‘open access’ movement3in publishing has changed perceptions and practices when it comes to publishing results. Authors and their institutions now pay to raise the profile of their clinical research. This has traditionally been done through clinical papers or reviews. However, we now see a rise in lay summaries, podcasts, video interviews, or infographics related to clinical work. This visibility helps organisations involved in clinical research secure recognition for their contributions to medicine and to garner attention beyond their own specialised field.

Until now, access to the latest progress in medical and clinical research was restricted due to the specialised language and technical jargon used. This is no longer the case; the open access movement in publishing is helping to increase opportunities for collaboration across disciplines. This may also influence funding and clinical research grants. After all, research findings, discoveries, and innovations that are accessible and understood by a lay audience are also accessible to funders.

Based on evidence in the public domain, these lay summaries result in a 23% increase in the number of paper downloads. That’s according to a studyon authors using Kudos to share their work; Kudos is a web-based service that “claims to help researchers communicate their work more effectively.”5  Further anecdotal evidence gathered from various publishers points to an even higher level of increase in original research paper downloads, in the order of 35% to 40%.

The value of convenience

When it comes to the practicalities of raising the profile of clinical research, the onus is on medical writers to deliver the clearest possible message. Like in any writing job, making sense of clinical research for a lay audience takes some skill. It requires experience and talent on the part of the writer to produce the clearest and most compelling explanation.

Until now, writers could only collaborate with editors through email and telephone communication. This is a time consuming and inefficient approach. Today, however, new technology can assist medical writers and editors in doing their job. Using available solutions to save time and effort, allows medical writers to make better use of their time and be more productive – that is, it allows them to spend time doing what they do best: writing and editing.

Specifically, emerging technology solutions reduce the medical writer’s need to spend time on ancillary tasks. The following sections explore the kinds of solutions that are available to assist medical writers.

Topic specific monitoring

Medical writers can keep an eye on trends in a particular disease area, for instance, by using the latest online monitoring tools such as the ones developed by EzyInsightsor Newswhip.For those who only need to monitor well-defined sites like ClinicalTrials.gov, more ‘old fashioned’ monitoring solutions such as RSS feeds may suffice; which also have the advantage of being free. Another solution is tracking topics related to specialist coverage to get real-time updates. This can be done by looking at what is trending on Twitter, using tracking solutions like Storyful,for example.

People monitoring

Keeping an eye on the progress made by specific clinicians is now possible by following them on the many social media networks for scientists, such as ResearchGate,Academia.edu,8or Mendeley.If specific researchers are part of a writer’s LinkedIn network, writers can see who is making the headlines by using LinkedIn’s ‘your connections in the news’ feature. Meanwhile, saving time transcribing interviews with principal investigators can be also done using automated audio to text transcription services such as Trint.10

All these solutions apply to the upstream background research and preparation phase of any piece of medical writing, whether it is a clinical paper, a lay summary, or any other article designed to raise the profile of clinicians. However, there are other valuable and newer tools now available to help medical writers in their day-to-day work.

Collaborative platforms

There are many available options for research and clinical paper authoring and workflow. However, these solutions often work in isolation from each other. For example, most existing authoring tools to write lay summaries do not include a workflow solution that allows medical writers to collaborate with specialist editors, who have the skills and expertise to deliver lay summaries.

Innovative platforms are opening new frontiers for collaboration. The days of multiple version files sent by email will soon be over, as will the lack of workflow clarity and control in shared Google DOCs. The new platforms include not only easy-to-use editing features but workflow and collaboration functionalities that add transparency and quality controls to the process.

ContentTools13,  for example, is a content editor that can be added directly to an HTML page. This allows content creators to work collaboratively in context on a web-ready page. The toolbar is dropped onto the page and text, images, embedded video, and layout can be edited in one place. It is also possible to limit editing to specific sections, so that assigned collaborators or clients can only edit targeted parts. It works as an easy-to-use word processing application for web pages.

Another platform, SMASHDOCs14, allows users to collaborate online on a single document with internal and external reviewers. New changes to a document are highlighted automatically and the history of changes is trackable on a sidebar. This solution also includes a notification feature, alerting users when changes have been made to a document. It has been targeted primarily for use in legal documents.

The two previous examples are broad-based, although SMASHDOCs has found its niche in the legal world. Another innovative platform for collaboration is SciencePOD, which offers solutions that specifically address the needs of science and medical writers and publishers. The SciencePOD online platform takes the tried and tested, quality-controlled editorial process to ‘the cloud’. It provides both authoring (online editing) and workflow solutions in one place.

Specifically, the SciencePOD platform allows users to find content creators and put together bespoke teams made up of the ‘best of the best’, capable of delivering a finished product that has undergone a process of several tiers of quality control and is of international publishing standards. SciencePOD has a global network of content creators. Thus, users can access not only the best talent for the job in their own locality, but also the best global talent. The work takes place on the online platform in real-time and the easy-to use and track workflow is fully visible.

SciencePOD also has plans for future automation of editorial and content creation processes. Examples of improvements include automated sourcing of raw background material, algorithms to recommend and select the best person and match them with a given job, part-automated lay summaries, and optimisation of meta-data formatting using extraction of key concepts from the text, using AI, to increase the discoverability of such content.

These innovative collaborative platforms offer a variety of features and functionalities that build-in efficiency, transparency, and save time. They offer solutions for the new needs of medical writers, and in the process, they are changing the way medical writers work and collaborate.

 


Collaborative web technologies at the service of medical writers

Key platform features and functionalities that will save medical writers time:

  • Talent management tool

A talent management tool makes it easy for publishers to put together teams of qualified medical writers, science journalists, editors, multimedia producers and proofreaders. Teams can work collaboratively on a platform to create high-quality content. Ideally, the platform should offer access to an international talent pool with expertise in science, technology, medicine, and innovation, and with a variety of language skills.

  • Authoring and workflow monitoring

A platform’s customisable workflow system saves time. Each piece of content processed through the platform can be subjected to various layers of quality control, by an editor and by a proofreader, for example. It can be used for the creation of lay summaries and for the delivery of clinical research papers or reviews as well.

  • Progress accountability in real time

A platform should be easy to use and intuitive. Each step of each ‘job’ should be trackable and tracked online, allowing ongoing quality control and more effective collaboration. The platform editorial process should be transparent, providing progress accountability in real time. Platform clients – news editors or marketing managers, for example – can then track and review any content before it is delivered.

  • Scalability

A platform solution should help create lay summaries (PLS) of research papers on a large scale and in multiple languages. Innovative platforms are developing semi-automated PLS of research papers using Artificial Intelligence algorithms. Machine summaries can be polished off by expert editors to ensure that the final product is of international publishing standards. This means that, ultimately, the usage of original research papers will increase as lay summaries make them more discoverable and higher profil.


 

Conclusion

Technology is changing the way medical writers interact with their editors and clients. Although the change requires working online, most of the time, it also enhances the interactivity of the editorial process and the ability to collaborate across borders. This means that technology will help increase the impact of clinical research, by making the creation of traditional clinical papers more time efficient. Meanwhile, the emergence of lay summaries, as a means to make clinical research more accountable, constitutes an opportunity for medical writers to diversify the type of work they deliver.

References

  1. EU regulation (536/2014) onclinical trials on medicinal products for human use. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf.
  2. Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/2017_01_26_summaries_of_ct_results_for_laypersons.pdf.
  3. Piwowar H, Priem J, Larivière V, Alperin JP, Matthias L, Norlander B, Farley A, West J, Haustein S. The state of OA: A large-scale analysis of the prevalence and impact of Open Access articles. PeerJ Preprints 5:e3119v1. 2017. Available from: https://doi.org/10.7287/peerj.preprints.3119v1.
  4. Erdt M, Aung HH, Aw AS, Rapple C, Theng Y-L. Analysing researchers’ outreach efforts and the association with publication metrics: A case study of Kudos. PLoS ONE12(8): e0183217. 2017. Available from: https://doi.org/10.1371/journal.pone.0183217.
  5. Kudos: https://www.growkudos.com/.
  6. EzyInsights: https://ezyinsights.com/.
  7. NewsWhip: https://www.newswhip.com/.
  8. Storyful: https://storyful.com/.
  9. ResearchGate: https://www.researchgate.net/.
  10. edu: https://www.academia.edu/.
  11. Mendeley: https://www.mendeley.com/.
  12. Trint: https://trint.com/.
  13. ContentTools: https://contenttools.co/
  14. SMASHDOCs: https://www.smashdocs.net/en/legal-documents
  15. SciencePOD: https://sciencepod.net/#dashboard

 

Sabine Louët founder and CEO SciencePOD

Author information

Sabine Louët has worked as a science journalist and editor for the past 20 years. She is the founder of the collaborative digital publishing platform SciencePOD (www.sciencepod.net). She previously worked for Nature Biotechnology (now part of Springer Nature) and strategic pharma intelligence publisher Windhover in Norwalk, Connecticut, USA (now part of Informa).

 

 

 

 

 

For further information

Sabine Louët,

Founder SciencePOD,

6/9 Trinity Street,

Dublin D02 EY47, Ireland

editor@sciencepod.net