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The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data of EU citizens. Medical writing includes the development of documents related to clinical research. To develop those documents, medical writers have access to personal data, including health information considered as sensitive data. Therefore, medical writing falls within the purview of GDPR and must comply with its requirements. This article is an overview of the impact of GDPR on medical writing including security measures such as anonymisation, pseudonymisation, and data minimisation techniques. It also provides an overview of the technical and organisational actions in the framework of medical writing to guarantee respect of data subjects’ rights and freedoms.

Developing drugs for cancer is a process as complex as the disease itself. At the planning stage of a clinical trial for an oncology drug, thorough and careful consideration must be given to choosing the right study design and endpoints/estimands, as any bias introduced at the outset of the clinical trial would cascade down to the analysis and eventually the reporting of the results. The common study designs for oncology drugs, their challenges, the current perspectives (and dilemmas) in the industry on choosing the right endpoints/estimands, design and reporting biases, and the roles of medical writers in facing these challenges are discussed in this article.

Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare professionals, and the public, and are used to assess the safety and efficacy of medical treatments. This article presents an overview of the steps involved in writing and submitting CSRs to regulatory authorities, as well as reporting clinical trial findings to the scientific community and the public.

A medical writer has a unique opportunity to be involved with documents across the various stages of a product’s lifecycle. At the start of their careers, writers typically specialise in documents that are created in a particular phase of drug development and are accordingly titled as early phase writers, late phase writers, publication writers, and so on. As writers progress in their careers, depending on each writer’s interests, they could be exposed to a plethora of documents across the writing continuum (starting from pre-clinical to post-approval phases of drug development). Writers thus have the potential to play an important role in ensuring data is disseminated to various stakeholders in a coherent and seamless manner throughout the product’s lifecycle. Let’s take a look at the various aspects to keep in mind as writers move from one document to the next and help connect the dots!

Designing clinical trials in rare diseases comes with a specific set of challenges including limited knowledge around the natural history of a disease, small sample size available for trial participation, regulatory guidance that is not calibrated to the rare disease context, manufacturing and supply issues, and safety and financial risks. Here, we discuss some of these potential challenges and how, through proactive early engagement with key opinion leaders, regulatory bodies, and patient groups, a cohesive and strategic clinical development plan can be created to provide the strongest foundations when marketing approval is sought.

The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible and collab orative. The EU CTR aims to harmonise clinical trial applications in the EU, bring more innovation to Europe, and enable faster approval of clinical trials. However, the novel process of clinical trial application in its early stages is fraught with technical and logistic challenges.

Titles of clinical trials may directly influence whether patients, caretakers, or healthcare professionals will want to obtain more information about the trial. Major clinical trial registries require lay titles (referred to as “brief” or “public” titles) that are understandable to the public. However, devising adequate lay titles is challenging. In this study, we assessed the quality of lay titles from Phase II/III and III clinical trials registered in ClinicalTrials.gov in 2021. Assessments included the presence of recommended elements, use of technical terms, an expert assessment of adequacy and informativeness, title length, and the use of acronyms. A large proportion (72%) of lay titles did not include all recommended elements, contained technical terms (73%), and were not adequate according to experts (51%). Often, brevity was given precedence over content and understandability. Generally, lay titles with acronyms had better ratings in all assessed categories. These results suggest that industry sponsors can do more to create lay titles that better inform patients and healthcare providers.

Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review processes along with different stakeholders. Poor peer review leads to protocol amendments, which delay regulatory submission and increase project costs. Thus, there is a strong need for RMWs and stakeholders to work together during the peer review process to highlight the specific issues that should be addressed before finalisation, which helps in creating effective, efficient, and high-quality protocols. The suggested protocol peer review steps described in this article will help an RMW to plan, coordinate, and deliver this highly important document for global and local clinical trials.

Decentralised clinical trials (DCT) use technology, processes, and services to reduce or eliminate the need for onsite visits. Use of DCT components within clinical trials is becoming widespread and protocols are pivoting from using DCT components as rescue tools during the COVID-19 pandemic to including them as integrated decentralised research methods. To date, there is no consolidated guidance for what DCT component content should be included in the protocol. To enhance clarity, completeness, and replicability in clinical trial protocols incorporating DCT components, this article outlines a simple scoping process for information gathering and summarises some common considerations around frequently used components. The objective of this article is to provide protocol authors with tools, resources, and guidance to better support the development of clinical trial protocols that include DCT components.

This article focuses on the medical device specific aspects of clinical investigations and does not aim to be a comprehensive introduction to clinical trials. We highlight the key differences to clinical studies of medicinal products in the context of regulatory requirements in Europe and discuss which documents are connected to the Clinical Investigation Plan. Finally, we discuss the different types of clinical investigations and the current status of the Clinical Investigation and Performance Studies module of EUDAMED (European Database for Medical Devices).

This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research information available to the general public. Sharing this information in a manner that is understood by those without scientific training is important. This article discusses plain language summaries, their requirements and benefits, and what additional steps should be taken to improve transparency in clinical research.

In 2021, EMWA members were asked to participate in a survey about their current salary and compensation. The survey included questions on some of the factors that typically influence earnings, such as education, geographic location, level of experience, and type of employer. Four hundred EMWA members responded. The aim of this article is to provide salary and compensation information for company employees and freelancers who are medical writers and communicators based on the responses of the EMWA members who completed the survey.

Sharing research data increases reusability, reduces waste, supports reproducibility and promotes innovation. In medical research, sharing data also promotes transparency and access to information relevant to patient care. While important advancements have been made in data sharing by regulators, the pharmaceutical industry and academic publishers, several barriers remain. Some of these barriers stem from concerns about data privacy and patient safety, but others are related to the need for confidence in sharing, which can be improved through agreed standards and systems for reuse of research data, including the application of FAIR (findable, accessible, interoperable, and reusable) principles and the overarching principle of “as open as possible, as closed as necessary”. Medical writers, who are key links between the pharmaceutical and publishing industries, can contribute to making pharma publication data FAIRer. They also have an important role in educating others about the path to more findable, accessible, interoperable, and reusable data.

Altmetrics and other article-level metrics offer new opportunities to understand the impact of medical publications and, indeed, clinical trial programmes. For example, we can learn whether the publication has been viewed, shared, engaged with, or cited on different platforms. These metrics have limitations, but new tools and techniques for aggregating and summarising different metrics are making it easier for publication planners to understand the impact of their publications.

There are three main types of accessible language documents that medical writers and medical publications professionals may work on. These are regulatory lay summaries, publication-associated plain language summaries (PLS), and standalone plain language summaries of publications (PLSPs). Although these document types have different purposes and audiences, they are often confused because of the similar names. Here, we outline the main differences between the three document types and present the different names used to refer to lay summaries across 58 pharmaceutical companies, totalling 22 names. We also show examples of the different literacy levels used in lay summaries and publication-associated PLS. Medical publications professionals need to be aware of the differences between these accessible language document types and the importance of being precise when discussing these. Standardisation of terminology could potentially help to avoid confusion.

Rather than equating disability with personal identity, we can better understand disability as the consequence of disabling environments. This alternative view suggests that changing the environment can enable people with sensory, motor, and cognitive/learning impairments to participate more fully in everyday life. This view is also consistent with the goal of medical writers to be aware of their audience (i.e. their relevant abilities/skills, cultural beliefs, and knowledge base). To achieve this goal, we must strive to create electronic documents that can be perceived and understood by people with a variety of impairments. The main objectives of this article are: • to increase awareness of the difficulties caused by inaccessible electronic documents • to describe guidelines for creating accessible electronic documents • to provide resources for continuing education

In January 2021, the single market of medicines of the Eurasian Economic Union (EAEU) was launched. This article describes the current status of the transition to unified rules for the registration of medicinal products and the main regulatory documents for conducting clinical trials in the EAEU region.

The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the requirements of the regulation with respect to the Protocol Synopsis and discusses their feasibility in light of the maximum page limit.

Trust is built gradually, and it is easily threatened, particularly in relation to pharmaceutical research. The potential for open access publishing and plain language summaries to contribute to improved trust in pharmaceutical research was discussed by experts at the Open Pharma Satellite Symposium, held at the Association of Learned and Professional Society Publishers Annual Conference and Awards 2022 in Manchester, UK. No single endeavour will win public trust overnight, but removing paywall barriers between all readers and sources of trusted information, and publishing research summaries that are written in accessible, plain English are important steps towards fostering greater trust in research. Both endeavours also have the potential to help the public make informed decisions about their health.