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The article offers information on how to write a complete accurate and clear clinical study reports and the importance of the reporting guidelines. Topics mention including raising awareness and encouragement routine to improve the clinical research papers, comprehensive list of reporting guidelines located at Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network and tips for writing a scientific style.

The article focuses on the difficulty of understanding scientific papers since they are usually written for a very specific audience. The importance of communicating one's work clearly to those outside one's field for any research is mentioned. It cites the three C's of good writring which include being clear, being concise, and being correct.

The article highlights the information on collaborating multi-authored papers in writing. It mentions the rules for collaborating like build writing team wisely, create data management plan, cultivate equity, diversity, and inclusion.

Thousands of clinical trials are conducted globally each year. Yet, little is known about their environmental impact. This paper presents the results of a high-level literature review of the carbon footprint of clinical trials. Five papers were identified and their contents summarised qualitatively. All papers were authored by UK researchers. Carbon footprint metrics from 14 trials were presented in carbon dioxide equivalents (CO2e). Emissions were broken down by three broadly defined clinical trial activities: operations, travel, and supplies. Recommen - dations for carbon reduction are discussed. The review showed a dearth of publications on greenhouse gas emissions generated by clinical trials. More work in this area is needed to achieve sustainable, low carbon clinical research. [ABSTRACT FROM AUTHOR]

The article reports on the credits for data sharing which include the definition and responsibilities of data authors, conflicts between the researchers and distinct data authors in the manuscript.

The article offers information on better writing which boost the impact of publications. Topics discussed include the gender inequalities which observed among authors who made equal contributions towards publications; and mentions reviewers of scholarly journals exhibit gender biases that influence outcomes of the peer review process.

The article focuses on elements that make up reference differ depending on the nature of the source, which may be a paper in a journal that is a chapter from a multi-authored book, an entire book, a conference presentation, a web page and so on. Topics include examines more authors and most carry the year of publication.

The article offers information on the publications about the Covid-19 pandemic in the journals. It discusses that new databases and websites have been created to compile the literature on Covid-19. It mentions the public health challenges faced by the Covid-19 pandemic, and how it impacted daily lives.

Plagiarism damages the biomedical academic publication domain. Artificial intelligence (AI) is a rising hope in academic plagiarism hunting. However, new AI-based tools are available online to assist with plagiarising! This article presents plagiarism throughout history, especially in medicine, and the promises of AI to detect a new type of plagiarism, namely Aigiarism. The danger of the above-mentioned AI-based services to help in paraphrasing copied texts is also highlighted, including some proposed solutions. [ABSTRACT FROM AUTHOR]

The Sustainability Special Interest Group (SUS-SIG) of EMWA was established in 2020 to support the United Nations 2030 agenda for sustainable development from the perspective of a not-for-profit professional organisation for medical writers and communicators. One of the SUS-SIG’s initiatives was to estimate EMWA’s carbon footprint, which can serve as a baseline for future carbon reduction strategies. This article presents the first estimate of EMWA’s annual greenhouse gas emissions, expressed as CO2 equivalent (CO2E). [ABSTRACT FROM AUTHOR]

The major change in medical decision making over the last 50 years has been the realisation that treatment decisions would be improved if doctors’ existing knowledge was supple - mented by evidence generated systematically through health services research. This paper discusses this changing paradigm and explains the related activities of evidence-based medicine, comparative effectiveness research, and health technology assessment. The latter is particularly important for making decisions on the provision of healthcare at the population level. The key steps in undertaking health technology assessments are explained, focussing on the types of literature they generate. [ABSTRACT FROM AUTHOR]

The article offers information on the differences in the British, American, Canadian, and Australian spelling. Topics discussed include why and how American spelling is different, the most common spelling error seen by the author in science papers in 2023, and typical Commonwealth versus American English spelling.

Package leaflets (PLs) have been legally required to accompany medicines in the EU since 1999. Despite the best intentions and efforts, however, they are generally not well-received by the public for whom they are intended. This paper picks up on the challenges that medical regulatory writers face in producing quality PLs using the official PL template when research indicates that patients would prefer a more personalised genre that incorporated their experiences and knowledge. This paper advocates greater inclusion of patients' perspectives, as this is currently achievable given the current legislation. The paper also notes the tantalising prospect of replacing the template with a set of recommendations that draws on knowledge of what works best for patients. [ABSTRACT FROM AUTHOR]

The article informs EMA has launched a public consultation on a reflection paper discussing single-arm clinical trials submitted as pivotal evidence for marketing authorisation applications, addressing considerations and challenges associated with this trial design in the context of rare diseases and small target populations. Stakeholders are invited to provide comments and feedback, which will be considered in the final version of the guidance document planned for publication in 2024.

Paper-based questionnaires are in widespread use for patient-reported outcomes, but they can be an inefficient way of collecting patient data. Electronic patient-reported outcomes are of wide interest and have the potential to drastically change patient data collection for the better. In particular, computer-adaptive tests can reduce the question burden for everyone involved. The US National Institutes of Health has funded the development of the Patient-Reported Outcome Measurement Information System. This exciting technology is being employed in many disciplines, including orthopaedic research. [ABSTRACT FROM AUTHOR]

The article discusses the potential implications of integrating artificial intelligence (AI) tools into the field of medical writing. It highlights how these AI tools can streamline various tasks and free up human medical writers to concentrate on unique cognitive skills. It also discusses the evolving role of AI in collaboration within medical writing and introduces Microsoft 365 Copilot, an AI-powered tool designed to enhance the user experience in Microsoft's productivity apps.

The article focuses on the relaunch of EMA (European Medicines Agency) Clinical Data Publication Policy 0070, effective from September 2023. It provides key details such as scope, early preparation recommendations for sponsors, the new Q&A document, and the use of a structured Anonymisation Report template. It also highlights the continuation of COVID-19 and public health emergency clinical data publication.

The article offers news briefs related to the European Medicines Agency (EMA). Expansion of the OPEN initiative from COVID-19 vaccines to a broader range of medicines, including those addressing antimicrobial resistance, RSV infections, and other hereditary diseases. Recommendation for marketing authorization of Abrysvo, an RSV vaccine, for passive immunization of infants and active immunization of adults aged 60 and older. Phasing out of extraordinary COVID-19 regulatory flexibilities.

Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharma co-dynamics of drugs. The role of these modeling and simulation (M&S) analyses is growing both in drug development and regulatory assessment. Reporting M&S analyses can be technically challenging given the large amount of input and output data that need to be summarised and accurately described in regulated reports. Therefore, reproducibility, automation, traceability, and standardisation are considered key aspects of this process. We present here a system that, using a combination of software, meets these challenges and improves the efficiency, accuracy, and reliability of our work. [ABSTRACT FROM AUTHOR]

Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to ensure safe and effective use. This article explores the utilisation and opportunities in three areas: medical devices (built-in software appli - cations); post-marketing surveillance (processing of large volumes of reported adverse reactions); and clinical development (pharmacokinetic profile, dose selection, clinical trial design, and regulatory writing). AI/ML-based applications are not perfect. Potential risks are enormous. Continued public/private engagement, vigilance, and oversight for all parties is essential for successful utilisation of these tools. [ABSTRACT FROM AUTHOR]

An interview with Michael Markie, Publisher at F1000Research and an open science and open data advocate, is presented. Topics discussed include differences between a traditional journal and an Open Science publishing platform; percentage of rejected articles after the pre-check; and impact of open science platforms on the future of the articles.

This paper describes the role of social media in healthcare and medicine based on the example of how a contract research organisation (CRO) uses video interviews to spread knowledge and expertise among professionals. Considering that in coming years, video content is expected to widely overtake text as the most common type of content on the internet, the article also provides recommendations for creators from the healthcare and medicine industries on how to leverage this channel. [ABSTRACT FROM AUTHOR]

The article reports on the controversies caused by meta-analyses in the sector of scientific science and mentions that scientists have to make several decisions and judgment calls that influence the outcome of a meta-analysis.

The first part of this article compares the main features of studies based on patient registry data with those of randomised clinical trials, providing a basis for better understanding the differences between the two. The second part details how to report study-specific issues with patient registries, such as study objectives, patient populations, bias, confounders, missing data, study duration, and gives a few tips on how to improve the credibility of papers based on patient registry data. [ABSTRACT FROM AUTHOR]

The article provides information on a Master of Science (Msc) in Science Communication at Manchester Metropolitan University in the United Kingdom which provides the opportunity to co-develop and co-deliver a Medical Writing module with representatives from a range of MedComms companies. Topics discussed include course approval, module development, and module description.

This interview provides solutions to some of the common pitfalls that face medical writers when working with large teams. Practical tips are provided on key topics including manuscript planning, agreeing on key messages and the use of figures, tables and other contents, deciding on the criteria for authorship, and dealing with contributors who fall short of their commitments. [ABSTRACT FROM AUTHOR]

This paper provides an overview of contemporary medical illustration; the role of the modern medical illustrator is examined, including who they are likely to work for and with, as well as the range of media and technology employed. The various applications of medical illustration are described with a focus on looking at how these are likely to change and develop in the near future. [ABSTRACT FROM AUTHOR]

The scholarly record is an ever-evolving network - or graph - of truth assertions on which each discipline bases its discussions, and against which each discipline measures its progress. But what if the scholarly record is missing a significant number of truths? In this article, you will learn about the scholarly record, what it comprises, and what's missing. You'll discover that the volume - and value - of what's missing, called grey literature, has been. Grey literature is a costly asset that's going to waste. [ABSTRACT FROM AUTHOR]

The article offers information on medical translation basics offers patient information sheets, clinical trial presentations, clinical science papers, training material, and pharmaceutical marketing material. Topics include target readers can be as varied as in medical writing general practitioners as well as health outcome experts, nurses, importance of translating into the translator's native language and knowing the target audience.

The summary discusses the issue of plagiarism in academic publishing, particularly in relation to the extent of text reuse that qualifies as plagiarism. It highlights different definitions and guidelines provided by organizations such as COPE and anti-plagiarism applications. The author, as a journal editor, shares their approach to addressing plagiarism and advises authors on how to respond to claims of plagiarism in their manuscripts.

Pharma-Brexit is on its way. The announcement of the European Medicine Agency's move to Amsterdam, various UK government white papers, and comments made by key stakeholders in the UK pharmaceutical industry have led to a wide range of predictions concerning Brexit. While many hope for a Norwegian-type situation where business as usual could continue uninterrupted, others fear that the uncertainty of a "no-deal" outcome has already started a domino effect that could lead to the UK pharmaceutical industry's collapse. This article argues that something in between is most likely and looks at what Brexit could mean in each scenario. It explores why and how both the EU and UK might work through a deal and how these challenges might still provide opportunities for medical writers. [ABSTRACT FROM AUTHOR]

The article discusses association between treatment effect estimates and publication characteristics and comparison between treatment effects between published and unpublished randomized controlled trials (RCTs) and between trials published in English and other languages. It presents challenges faced in bibliometric search and publications.

The article discusses that the Social media in the medical device industry as a tool for post-market surveillance. Topics discussed include the European Union Medical Device Regulation publication (EU MDR 2017/745), it became clear that post-market surveillance (PMS) would require significant changes; and the need to implement PMS activities different from traditional ones became apparent in white papers and conferences.

The article examines EMWA predates the European Union, which was officially formed in November 1993 in Maastricht, the Netherlands. Topics include examines over a year later, the European Medicines Agency opened shop in January 1995 and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) founded in 1990.

Editors of English are typically met with expectations to make a quick fix of documents that need more radical changes than authors think. As editors, we should convey how we work to improve readability, and either adjust or gain acceptance for our approach. Next steps are to identify and discuss illogical, ambiguous content, check grammatical issues in the writer's first language that are different in English, and anything that deviates from clear, concise, consistent, well-formed prose, focused on the research question. A good way of communicating effectively with authors is to give reasons for suggested changes, and ideally, to name the problems. [ABSTRACT FROM AUTHOR]

The article informs the European Medicines Agency's veterinary medicines committee (CVMP) made recommendations to reduce the risks associated with N-methyl pyrrolidone (NMP) the health of women handling these medicines and the offspring of animals receiving them.

The article presents news related to the medical writing including Clarity and Openness in Reporting: E3-based on the review of the TransCelerate Template for clinical study report. It discusses the TransCelerate released updated versions of their content-driven clinical study report on the template and SAP template.

An interview with Richard Wheeler, principal investigator in parasite cell biology at Oxford University and expert in the tropical parasites Leishmania and Trypanosoma is presented. Topics discussed include his research career, Trypanosoma and Leishmania cause several neglected tropical diseases, including sleeping sickness, Chagas disease, leishmaniasis and his advise as being the main pros and cons of each career path.

This paper describes how to register, access, and navigate the EMA clinical data website. One of the authors (RB) is a medical writer and accessed the site from the perspective of a pharmaceutical industry professional. The other author (AS) is not affiliated with this industry and accessed the website from the perspective of a lay person. Both authors reside outside of the European Union and were impacted by the role of geography in access rights and terms of use. [ABSTRACT FROM AUTHOR]

The article discusses the growing problem posed by illegitimate predatory journals in the research community, citing papers published by research team Centre for Journalology which identified the criteria of predatory journals.

The article reports that the European Medicines Agency (EMA) is inviting public comments on a reflection paper regarding development of medicines for older people as of January 2018.

The article offers information on the list of links, are blogs, podcasts, videos, and YouTube channels to offer more creative explanations, including discussion on blogs and social media for medical writers.

The article inform the International Committee of Medical Journal Editors (ICMJE) updates its influential document "Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.

The article focuses on a real-life experience with predatory journals. It mentions re-reading the excellent American Medical Writers Association (AMWA) –European Medical Writers Association (EMWA) joint position statement on predatory publishing; and also mentions the list of characteristics of predatory journals and their publishers was also very helpful since we planned to introduce a standard operating procedure for journal verification.

Despite the rise of social media, high-speed internet, and teleconference software, conferences seem to be here to stay. But what is their purpose? Networking. So why then do we design conference posters in a way that makes people run away from us? In this article you will learn why a scientific poster should be an eye-catcher and a conversation starter and how to design effective posters with the reader in mind. A poster should be a visual abstract of your research, not a wall-of-text. Beyond the conference, graphical abstracts can be effective tools for broadening the reach of research and are becoming more commonplace in scientific publishing. When it comes to effectively engaging with your audience, it is time to break the status quo. Let us bury the wall-of-text posters and embrace graphical abstracts. [ABSTRACT FROM AUTHOR]

As modern medical writers, we face a changing communication landscape greatly altered by the arrival of the internet and the rise of social media. This article provides insights on how to keep pace and what options you have to make your written content more visually attractive. Graphical abstracts or infographics are effective visuals to capture attention, enhance comprehension, and increase information recall. Online tools like Mind the Graph or Piktochart provide a great base to get you started in the creation of your own powerful visuals without having to involve a graphic designer. The importance of promoting content, e.g., through social media, is highlighted, as this will help you to attract and reach your target audience in the crowded online space packed with information competing for attention. [ABSTRACT FROM AUTHOR]