Medical Writers Research Articles

Dr Richard Davies (1708–1761): Reform, Contagion, Blood and Inflammation

Though he is nearly forgotten today, Dr Richard Davies (FRS 1738–41) was an innovative medical writer, a controversial educational reformer, and a path-breaking haematologist. His research on the composition of human blood, especially the formation of a ‘buffy coat’ in fevers, anticipated the better-known work of William Hewson and may have contributed a greater understanding of the behaviour of blood in health and disease, the effects of inflammation, and the outcomes of venesection. Davies had hoped that his works would contribute to a larger discussion made possible by a new community of better-educated medical researchers, but his ambition was thwarted, his claim to intellectual property was ridiculed, and his work did not receive the credit it deserved. This article reviews Davies’s life and works and suggests some explanations for his obscurity.

Advance Your Writing Skills: Craft Effective Multiple-Choice Questions for Continuing Education Activities

Health care professionals are required to participate in continuing education activities to maintain their competency and improve their clinical skills. These educational activities are often developed by medical writers who create the course content and postactivity multiple-choice questions (MCQs). The MCQs align with the learning objectives and assess the learners’ comprehension of the information and their ability to apply the knowledge in a clinical setting. The MCQs also help evaluate the educational outcome of the activity and guide future educational programs. Medical writers can craft high-quality MCQs for continuing education activities by following key recommendations that enhance knowledge and build skills in medical professionals, effectively contributing to improved patient care. This article offers an overview of the recommendations for writing effective MCQs for continuing education activities.

The Call of the Open Road: Is Medical Writing Right for You?

The questions I’m asked about medical writing are often “how do I become a medical writer?” or “what is the best background?” or “what kind of training is crucial to success?” I’d like to humbly suggest that these are the wrong questions. I think a better question might be, “how do I know I’ll be happy as a medical writer?”

Training the Medical Writers of the Future Using a Structured Entry-Level Program: A Life Sciences Communications Agency Perspective

Ensuring that associate medical writers are set up for success requires a well-planned entry-level program that integrates training sessions with on-the-job experience. We describe how we have crafted our program for entrylevel candidates starting from our interview process and moving to our training program, how we embed them into teams and provide on the-job training, how our support network is structured, and how we measure success. Feedback from recent participants in our training program offers valuable hands-on insights. A robust foundation of publication training is key to the development of our medical writers, providing skills and helping them develop many of the key attributes that underpin success, including attention to detail, effective storytelling, and industry compliance. Our profession is not static, and training programs need to be agile and pivot quickly to accommodate evolving industry standards, new technologies, and fluctuating client and audience needs and challenges. Staying up to date with future developments in medical writing is crucial, and we do our utmost to train and support our team and futureproof our training, so our junior writers are well equipped to excel and have fulfilling careers in the life sciences communication industry.

The Essential Elements of the Discussion Section of a Research Manuscript

Many medical writers believe that the Discussion is the most difficult section of a research manuscript to write, largely because of its structural flexibility and open-ended nature. However, medical writers can build confidence in writing this section by ensuring that the Discussion includes the essential elements: a summary of the major findings, interpretations of the important findings, descriptions of the implications and applications of the findings, a discussion of the strengths and limitations of the study, details about recommended future directions, and statements of the significance and relevance of the work. These essential elements help to form an effective Discussion that showcases the study and highlights its impact to the field.

European Union Regulation on Personal Data Protection in Medical Writing

The European General Data Protection Regulation 2016/679 (GDPR) aims to harmonize data protection laws across European Union (EU) Member States. The goal of GDPR is to ensure respect of the fundamental right to protection of the personal data and privacy, to enhance security measures, including information technology (IT) for data protection, and to render natural persons control over their personal data. Importantly, companies, institutions, freelancers (including medical writers) located outside the EU and handling personal data of natural persons living on the territory of the EU must comply with GDPR. Medical writers edit documents related to the activities in health sector that comprise personal data, specifically health data considered as sensitive data. Therefore, medical writing should put in place robust security measures and comply with the GDPR. This article is a clarification of the GDPR notions, principles, technical and organizational measures applied to the medical writing to guarantee protection of the personal data and respect of individual’s rights and freedoms.

Is the Hype Real? Real-Life User Experience of an Artificial Intelligence Tool for Clinical Study Report Production

We all know that artificial intelligence (AI) is changing the world we live in, and the world of medical writing is no different. The explosion of AI is creating significant opportunities in identifying data signals, document creation, and supporting the work of medical writers. This article summarizes how the medical writers in my company, Trilogy Writing & Consulting, have been using a rule-based AI tool (that we purchase as a Software as a Service license) to augment their writing of clinical study reports (CSRs) and is a summary of a talk that I gave at AMWA’s 2023 Medical Writing & Communication Conference in Baltimore, Maryland, on October 26, 2023.

Questions and Answers From Freelance Pros

What advice would you give to freelance medical writers, editors, or communicators who are new to medical writing and have limited writing experience? What are the top software tools for new medical writers? What is the role of generative artificial intelligence in medical writing? In this issue, our Freelance Focus contributors are: Melissa L. Bogen Lori De Milto Cathryn D. Evans Alex Howson

Cultivating Passion and Curiosity in Medical Writers: The Need for Dynamic and Agile Training Programs

My journey in writing began in 1999 as a science communicator right after grad school, before moving to regulatory writing in 2005 with minimal formal training. Early on, I was handed the ICH E3 guidance for clinical study reports and had to navigate through it on my own. My tasks varied daily, ranging from clinical data reporting to understanding submission procedures, including physically preparing documents for US Food and Drug Administration submission—the blue pronged folders are memorable. Fortunately, today’s training resources and electronic submissions make the process much smoother.

Medical Writing and Editing Internships: Preparing the Next Generation of Medical Communication Professionals

Conference Education Session Report Speakers Barbara Gastel, MD, MPH, ELS(H), Professor, Texas A&M University, College Station, TX Joan Affleck, MA, MBA, Associate Vice President, Head of Medical Writing, Merck & Co., Inc., Rahway, NJ Moderator Erica Goodoff, ELS(D), Senior Scientific Editor, The University of Texas MD Anderson Cancer Center, Houston, TX

2024 John P. McGovern Award Recipient: Dr. Eliseo Pérez-Stabl

Each year the president of the American Medical Writers Association (AMWA) has the honor of selecting the recipient of one of our organization’s highest honors, the John P. McGovern Award. AMWA bestows this award to a member or nonmember of AMWA to recognize a preeminent contribution to medical communication.

Sneak Peek of the AMWA 2024 Medical Communication Compensation Survey Results

As the leading professional organization for medical writers, editors, and communicators, AMWA has been conducting periodic compensation surveys since 1989. This research is designed to provide insights into income, and the factors that affect it, within the field of medical communication. The AMWA 2024 Medical Communication Compensation Survey was conducted in March and April 2024 by an outside research firm, Association Research, Inc (ARI). ARI will deliver the final, comprehensive report to AMWA in Fall 2024. AMWA members will receive full access to the report as an exclusive member benefit. On the following pages, infographics highlighting select results from the full-time employed and full-time freelance medical communicator data sets (respectively) are presented.

Advantages and Applicability of a Master Class Series as a Training Model for Mid-Career Medical Writers: Our Experience From the Perspectives of the Manager, Trainer, and Participants

Advancement of mid-career medical writers (MWs) to senior levels requires augmentation beyond the traditional training provided to MWs at all levels. In response to this need, online training and classes taught by more experienced writers in house, external lecturers, or a mixture of both delivered through didactic presentations should be supplemented with methods that allow for interaction between the trainer and trainees and for a tailored approach. We therefore designed an interactive, engaging, and dynamic training model that would draw on varied perspectives of colleagues. This Master Class Series was led by an external instructor and was based on a structured critique of regulatory document organization, content, and style. In this article, we share our experience from the perspectives of manager, trainer, and participant. The Master Class Series was successful in part because of its dynamic content. The participants felt that this training greatly improved their understanding of the broader contexts in which documents are used and their ability to develop coherent documents. Participants further felt that their ability to implement a top-down approach in strategy documents and in applying lean writing principles was enhanced. They all agreed that they greatly benefit from exposure to each other’s creativity in solving challenges in data and content presentation and concurred that it is very likely that they would sign up for a course with a similar model in the future. Our experience indicates that a Master Class Series is essential to the training of mid-career MWs.

Innovate, Inform, And Inspire: Jazz Up Medical Communication at the 2024 Medical Writing & Communication Conference

It's almost here! Get ready for the AMWA 2024 Medical Writing & Communication Conference in the Big Easy. This year’s conference is scheduled for October 23 through October 26 at the New Orleans Marriott hotel. Register now for the conference at the Annual Conference website (https://site.pheedloop.com/event/AMWA2024/home/).

Clinical trial transparency and disclosure from the medical writing perspective

It’s been more than 6 years since our last Medical Writing edition dedicated to clinical trial transparency and disclosure. Since then, we have seen the full implementation of the long-awaited EU Clinical Trials Regulation (CTR), the pause and restart of EMA Policy 0070, and of course a global pandemic which resulted in a world-wide surge in freedom of information requests for Covid-19 vaccine clinical trial data. Although many of the regulations and policies governing public disclosure of clinical trial data and documents remain unchanged, we have seen significant changes in the way these are implemented. As those of us who work in this field know all too well, the landscape is ever changing, and it is essential to keep up to date with those changes. Resources such as the Drug Information Association Clinical Trial Disclosure Community, PHUSE Data Transparency Working Group, and Clarity and Openness in Reporting-E3 based (CORE) Reference provide invaluable updates and insights. This issue of Medical Writing touches on a number of different aspects of clinical trial transparency and disclosure, all of which involve medical writers as key stakeholders

Protection of personal data and commercially confidential information under the Clinical Trials Regulation (EU) No. 536/ 2014 – EMA “Revised CTIS Transparency Rules”

The Clinical Trials Regulation (EU) No 536/2014 (CTR) came in force on January 31, 2022, specifying requirements for performing clinical trials in the EU and the European Economic Area (EEA). The CTR and the Clinical Trials Information System (CTIS) harmonise the approval process of clinical trials across the EU/EEA, provide a transparent process, and increase public access to information from clinical trials. Such transparency efforts must assure protection of personal data and commercially confidential information. The CTIS transparency rules were revised and recently implemented. The revised CTIS transparency rules focus on easier and earlier access by the public to documents of primary focus for patients and researchers. This article highlights the protection of personal data and commercially confidential information in public clinical trial documents according to the revised rules and also the EMA Policy 0070, which have overlapping transparency requirements. Medical writers and other functions involved in the preparation of regulatory documents during the clinical drug development play an integral role in applying transparency principles.

Navigating the new era of clinical trial transparency

This issue of Medical Writing comes at a time when the summer holidays are behind us. Here’s hoping it has been a relaxing and rejuvenating time for all. As we get back to our day-to-day work, our fellow EMWA colleagues bring us an expert insight into the latest requirements in clinical trial transparency and disclosure. As medical writers, this has been on our agenda for many years now, but as we look to the future, transparency in clinical research is emerging as more than just a regulatory requirement – it is a cornerstone of public trust and ethical responsibility.

Preprints: Why and how to use them

Preprints are a key part of science communication and publication strategy. Medical writers should therefore help inform authors about preprint options. In this article, I present the arguments for and against using preprints and provide practical considerations when posting, disclosing, updating, and citing them.

Making the leap: Transparency requirements for clinical trials moving from one regulatory framework to another

This article discusses the fast-approaching deadline for sponsors to transition ongoing clinical trials in the EU/European Economic Area from the Clinical Trials Directive 2001/20/EC to the Clinical Trials Regulation 536/2014. In particular, the authors discuss the medical writer’s crucial role in ensuring that documentation meets the regulation harmonisation and transparency requirements; they also highlight challenges seen when redacting commercially confidential information in the preparation of transition applications.

Communicating About and With Artificial Intelligence Applications

This session provided attendees with an overview of the elements of artificial intelligence (AI) that medical communication professionals can use in their decision-making when communicating about and with AI applications. Knowing how to determine if an AI application is reliable and secure guides the professional in their assessment of applications they write about and their choice of applications they use in their practice. In turn, this ability to assess AI applications underpins professionals’ abilities to identify and apply best practices for developing and writing about AI. Taken together, this understanding of how AI works, how applications are developed, and how to identify and ethically apply best practices will guide professionals in their communication about and with AI applications. Editor's Note Developments in artificial intelligence (AI) will continue to be of critical importance to medical communicators for the foreseeable future. Accordingly, AMWA Journal expects to continue to feature AI-related articles in upcoming issues. Given how rapidly advancements are occurring in AI as they relate to medical communication, we are striving to be as timely as possible in bringing relevant articles to you. In this spirit, we are supplementing the Summer 2024 Digital Revolution theme issue with a timely article titled ‘Communicating About and With Artificial Intelligence Applications’ by J. Kelly Byram, based on a presentation made by the author at the most recent AMWA Medical Writing & Communication Conference.