The 58^th European Medical Writers Association (EMWA) Conference began with a series of Hybrid Conference days where attendees learned about the latest trends in reporting and conducting real-world evidence (RWE) studies, explored best practices for medical translation, and heard from journal publishers about how to navigate the challenges and opportunities presented by artificial intelligence (AI) in medical writing. The Publication Plan were in attendance to summarise the sessions for the benefit of those who were unable to attend, and as a timely reminder of the key topics for those who did. You can read our summaries of the sessions on RWE and Medical Translation below.

Our report of the Publishers’ Perspectives on AI symposium is available here.

Updates on best practices for conducting and publishing real-world evidence studies

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KEY TAKEAWAYS

• When reporting RWE data, consistency and transparency are vital to avoid potentially catastrophic outcomes.
• New guidelines, tools, and registries are available to aid compliance.

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The road ahead

Andrea Bucceri (Lumanity, EMWA Medical Communications Special Interest Group) opened the session with a ‘road’ analogy: randomised controlled trials (RCTs)—with their homogenous populations and eligibility criteria—may be likened to a clean, well-surfaced road. By contrast, RWE studies—with their heterogeneous populations, missing patient details, confounders, data gaps, and lack of randomisation—are akin to a muddy, potholed road. Clear guidance is therefore essential.

Clear guidance is essential when embarking on an RWE journey.

When reporting RWE data, consistency and transparency are vital to:

• allow comparison of data from different RWE studies
• plan future studies and interventions
• improve reproducibility.

Bucceri stressed that “major disasters” can occur when reporting guidelines are not followed, exemplified by the embarrassing retraction of the hydroxychloroquine study from the prestigious Lancet journal during the COVID-19 pandemic. Bucceri asserted that in this instance, the authors were supposed to apply the RECORD and RECORD-PE reporting guidelines but failed to do so. Three of the authors stated that they were unable to access the raw study data due to legal issues.

Several other RWE reporting guidelines exist, including the STROBE-ME (observational studies—molecular epidemiology), STREGA (genetic association studies), and REMARK (REporting recommendations for tumour MARKer prognostic studies). In addition, regulatory and Health Technology Assessment bodies have issued RWE study reporting guidance, such as the European Medicines Agency (EMA), National Institute for Health and Care Excellence (NICE), and the US Food and Drug Administration (FDA). Bucceri observed that all these guidelines were developed after the COVID-19 pandemic, which highlighted the importance of RWE in public health decision-making, and prompted regulatory agencies to regulate the RWE field more closely.

Some professional bodies have chosen to go beyond these broad frameworks to develop guidelines tailored to specific disease areas. In the second part of the session, Bucceri highlighted one such guideline: the European Society for Medical Oncology Guidance for Reporting Oncology real-World evidence (ESMO-GROW).

The ESMO-GROW guidance for reporting oncology real-world evidence

ESMO-GROW is the first expert-based guidance designed specifically for reporting oncology RWE studies. A multidisciplinary expert taskforce developed the guidance in response to concerns that existing guidelines lacked specificity, and that the need to use multiple complementary guidelines was proving burdensome to authors and journals.

Available as a free online tool, ESMO-GROW can be used to report descriptive, analytical, and pragmatic RWE studies. The tool consists of 35 reporting recommendations across 6 sections spanning the title of the manuscript through to its discussion and conclusions. Each section contains specific recommendations about what to include in the manuscript, with the aim of standardising oncology RWE publishing output. The tool asks the user to select whether they have fully reported, partially reported, or not reported each recommendation (or whether the recommendation is not applicable), and on completion provides a score by which to assess compliance.

The guidance was developed in consultation with and will be available as part of the EQUATOR network. The ESMO-GROW criteria are already in use, and Bucceri advocated acknowledging the tool whenever it is used in a manuscript.

What to include in your manuscript: the experts’ view

For the next part of the session, Bucceri presented feedback from RWE journal editorial board experts about what to include in manuscript submissions.

All studies (regardless of size) that are well-conducted, novel, and that address an important clinical question are worth publishing!

Of note, editorial experts stressed that all studies (regardless of size) that are well-conducted, novel, and that address an important clinical question are worth publishing! This is particularly true of RWE studies, which often include populations excluded from traditional study designs such as the elderly, children, or pregnant women.

Specifically, submitting authors should:

• Provide a detailed rationale for the study
• Pre-register the study in a public repository (and provide details of pre-registration)
• Address strengths, limitations and confounders in a dedicated paragraph within the Discussion (limitations and confounders are sometimes more interesting than the data itself)
• A qualified statistician should be among the authors, with their contribution clearly stated
• Work closely with their statistician to report and minimise bias in the manuscript
• Provide a detailed protocol of data extraction, including key variables (plus lists and codes) and combinations for defining study subjects, and detail who performed the extraction
• Exercise caution when using significance testing – correlation does not prove causation!
• Conclusions must be in line with the data presented!

Pre-registration

Bucceri then focussed on pre-registration, the process of publicly sharing a research and analysis plan in advance in a public repository. Pre-registration may help prevent overfitting, p-hacking, cherry picking, or HARKing (Hypothesising After the Results are Known), increase transparency and rigour, and boost public confidence in research. The EMA and FDA have issued their own guidance on pre-registration.

Stakeholders have previously raised concerns that registries such as ClinicalTrials.gov were not built with RWE studies in mind. To address this, The Professional Society for Health Economics and Outcomes Research (ISPOR) and other collaborators have developed the Real World Evidence Registry—a purpose-built platform for RWE study pre-registration. The registry is not specific to the EU and can be used by researchers globally. It is also suitable for medical device RWE studies.

Furthermore, the EMA and Heads of Medicine’s Agencies (HMA) have launched the HMA-EMA Catalogues of real-world data sources and studies (with an accompanying Good Practice Guide). Potential uses of these catalogues include data source identification and benchmarking of data sources via metadata.

In the Q&A, questions were raised about how journals check that pre-registered studies are eventually published. Bucceri responded that this is good practice but not mandatory, and that the imperative to do this should be policy-driven from companies themselves. He acknowledged that incomplete studies are an ongoing issue.

The home run

At the end of the Q&A, Bucceri closed the session with a baseball analogy from the expert feedback he had received. The editorial board experts have a ‘three strikes’ policy regarding RWE study manuscript rejection:

• If the study was not pre-registered…strike one!
• If the rationale is not properly defined…strike two!
• If the statistician is not in the author list…STRIKE THREE (manuscript rejected)!

But if you have all of them in your RWE study submission, you have a good chance of a home run!

The essentials of medical translation: foundations and best practices & key translation topics

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KEY TAKEAWAYS

• Medical translation requires specialised expertise, combining language skills, subject knowledge, research, and precision, often under tight deadlines.
• Addressing source document issues and expanded training for writers and translators are critical to improve clarity, reduce errors, and streamline processes for creating global content.
• Technology integration and effective workflow management are a key part of ensuring compliance, quality assurance, and efficiency.
• AI, as in medical writing, can support processes under strict human supervision to mitigate risks related to confidentiality, accuracy, and regulation.

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This seminar was co-chaired by Ana Sofia Correia (EMWA Medical Communications Special Interest Group – Translation Enthusiasts Subgroup), Claire Harmer (EMWA Medical Communications Special Interest Group – Translation Enthusiasts Subgroup), and Valentina Luridiana (TREMÉDICA) and provided an in-depth overview of medical translation, underscoring the unique demands and best practices within this specialised field.

The session was structured in two parts. The first half—Foundations and Best Practices—featured presentations addressing critical aspects of medical translation. These included the profile and skills of medical translators, key workflows for effective translation (such as managing multilingual content and documentation requirements), and strategies to overcome common challenges. The second half—Key Translation Topics—offered a series of focused breakout sessions where attendees and presenters could exchange ideas and experiences. These sessions explored topics such as the expectations, needs, and challenges faced by stakeholders, best practices for creating translation-ready materials, the role of technology, strategies for culturally sensitive translation, and the variety of translation services available.

The presentations highlighted the essential skills for those interested in entering the profession, the complexities of navigating the medical and pharmaceutical sectors—particularly for medical translators and writers, who comprised nearly two-thirds of the session attendees—and the role of technology, especially in an industry with strict regulatory requirements.

“Translators in the pharmaceutical industry are a bridge connecting patients, healthcare providers, and pharmaceutical companies across borders.” – Elisa Manzanal Merino

The multifaceted role of the medical translator

In the first presentation, Alina Cincan (Inbox Translation) discussed how medical translators, often from diverse backgrounds, need a unique blend of skills to perform their role. Key attributes include a robust grasp of source and target languages, a solid understanding of the life sciences, strong research skills, discipline, time management, and accuracy, to name a few. Translators must also navigate additional challenges such as:

• complex terminology
• convoluted source texts
• challenging deadlines
• emotional challenges (reviewing sensitive patient information or critical diagnoses can be emotionally taxing)
• inadequate translations from machine translation or translation memories.

Several solutions and specific tools and tips were offered, whether undertaking continuing professional development or adopting software like AntConc, a free corpus analysis toolkit for text concordancing and analysis.

The future of translation, given the advent of AI, featured throughout the presentations, with a particular focus on the concerns and risks related to confidentiality, accuracy, regulatory matters, and non-specialist datasets; however, Cincan acknowledged that medical translation has seen less impact compared with other specialisations. Cincan concluded with some final recommendations for translators, including continued specialisation, networking, joining professional associations, and keeping abreast of developments.

Traversing complex workflows for accurate and compliant translation

Representing the perspective of a medical translation agency, Yana Safina (mt-g) elaborated on how their workflows—such as those for complex multilanguage projects in the sphere of clinical studies—are shaped by compliance with the International Organization for Standardization (ISO); these include standards for translation, proofreading, back translation, and master review; machine translation and post-editing; and text analysis, translation, and revision. Safina also highlighted the advantages of computer-assisted translation (CAT) tools, including time efficiencies, consistency, and improved formatting. While beneficial for some projects, these tools have their pitfalls and intricacies, but agencies are well positioned to provide knowledge and advice on their use.

Safina also emphasised the complementary role of machine translation and post-editing, which can accelerate workflows without replacing human translators, before moving on to quality assurance. This crucial and comprehensive process begins with tested translators, client requirements, feasibility checks, and desired ISO standards; continues with established workflows, preparation of source texts, and choosing a CAT tool; and ends with translation memory and terminology checks, internal quality assurance in the CAT tool, desktop publishing, and layout checks. Once again, the potential of AI was mentioned in relation to integration with or replacement of CAT tools, with testing underway in the quality assurance process.

“AI and machine-learning applications used for drafting, compiling, editing, translating, tailoring, or reviewing medicinal product information documents should be used under close human supervision.” – EMA Reflection paper on the use of AI in the medicinal product lifecycle

A prescription for precision: meeting the rising demand for medical translation

In the second part of this seminar, Elisa Manzanal Merino (Normon Laboratories) shared insights from her role as an in-house pharmaceutical translator, allowing her to explore the intersection between the pharmaceutical industry and translation, and between language and science more broadly. The industry’s remarkable growth has led to rising demands for precise, highly specialised translation services. With the global demand for new treatments and emerging markets driving the need for multilingual documentation, translators in this field require deep subject matter expertise and familiarity with resources like the EU and US pharmacopoeias and International Council for Harmonisation guidelines.

The medical translation industry’s remarkable growth has led to rising demands for precise, highly specialised translation services.

Pharmaceutical companies may require in-house teams to provide ‘inverse translation’ (ie, translating from your native language into your non-native language); the dominance of English in scientific and pharmaceutical contexts and restricted timelines or small in-house teams potentially influence this demand. While outsourcing is common, in-house translation departments offer advantages, including streamlined workflows, rapid query resolution, and quality consistency. This efficiency is essential given the volume and variety of documents, from registration dossiers to marketing materials and patient-facing leaflets.

“Without translation, we would be living in provinces bordering on silence.” – George Steiner

Celestial navigation: following the sun to meet translation and localisation challenges

Courtney Vasile, a senior localisation project manager at Medtronic, discussed the challenges specific to the MedTech sector, where geographical and technological considerations come into play in their translation practice. At Medtronic, their complex workflow involves a two-step process of translation and revision, completed by two different linguists (native speakers who have extensive medical translation backgrounds), followed by extensive quality assurance checks and review by an in-country subject matter expert.

A ‘follow the sun’ approach ―leveraging global teams in the medical translation process― can help to balance tight deadlines and the need for high-quality outputs.

Though the process can be cumbersome when balancing tight deadlines with the need for high-quality outputs, in-house departments allow for agility when it comes to resolving queries, and there are more opportunities to educate internally and with clients on the complexities of the translation process. Furthermore, they have adopted a ‘follow the sun’ approach to leverage global teams and support rapid turnarounds, with offices spanning multiple time zones. Though their challenges might be considered standard across the industry, ongoing training, whether on writing for a global audience or how to use their proprietary content management system effectively, ensures a solution-oriented approach and a focus on innovation.

In summary, medical translation requires subject expertise, precision, and a commitment to quality underpinned by best practices that embrace technology integration and collaborative workflows.

With this in mind, the breakout rooms allowed for a deeper discussion on key translation issues:

• Mapping the medical translation ecosystem: Roles, expectations, and challenges – moderated by Katarzyna E Slobodzian-Taylor (Mastermind Translations)
• Translation-ready materials: Best practices and the role of the translation brief – moderated by Ana Sofia Correia
• Technology and translation: What tools do medical translators use to enhance quality and increase productivity – moderated by Thomas Tolnai (Tolnai Translations)
• How to produce a medical translation that is culturally sensitive? – moderated by Nur Ferrante (Art of Diversity)
• Beyond traditional translation: Exploring diverse modalities in medical communication – moderated by Claire Harmer

As Manzanal Merino summarised, “translators in the pharmaceutical industry are a bridge connecting patients, healthcare providers, and pharmaceutical companies across borders”. Medical translation is a driving force behind equitable access to healthcare, and this seminar emphasised the essential role that translators play in safeguarding accuracy and compliance within healthcare communications.

Our report from the Publisher Perspectives on AI session can be found here.

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Written as part of a Media Partnership between EMWA and The Publication Plan, by Aspire Scientific, a proudly independent medical writing and communications agency that believes in putting people first.

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