AMWA Journal

From the President

R. Michelle Sauer — Thu, 14 Mar 2024 00:00:00 -0700

Howdy AMWA,
I have 2 children, and during this time of year, parents are asked to volunteer for career day. I don’t know about you, but when I tell people I’m a professional medical communication expert, most have never heard of our profession. Doctors, nurses, and scientists have well-established roles in our society, but medical communicators still remain off the radar of most young people’s career options. As I begin to describe what I do to my kids, their eyes often glaze over but, when speaking to friends and the public, many are interested and see the obvious value we, as communicators, bring to the health care fields and beyond. As I speak with students, scientists, doctors, nurses, and medical liaisons, I find myself telling them, “You are a medical communicator too.”

The Gut Microbiome–Human Body Symbiosis: Relevance of the Ubiquitous Microbial Community on Health and Development, Part 2

Smitha S. Dutt, PhD — Thu, 14 Mar 2024 00:00:00 -0700

The human gut microbiome, comprising a range of microbial species (~100 to 1,000), is an extremely malleable ecosystem. It originates around the time of human birth and evolves as the infant grows until it matures into the relatively stable adult gut composition. Through this dynamic evolution, the composition of the gut microbiome is influenced or altered by factors such as diet, environment, mode of birth, genetics, infections, and medications. Strong associations between such alterations (dysbiosis) and diseases have led scientists to develop therapies that target a malfunctioning gut. Research is now focused on the microbiota or their associated metabolites as potential therapies. Treatment options explored include prebiotics, probiotics, postbiotics, synbiotics, fecal microbiota transplants, and live biotherapeutic products. The gut microbiome is not a panacea for all health issues; rather, it is part of a large network of interconnected operating systems within the human body. As communicators of scientific data, medical writers play a vital role in educating the public on the merits and limitations of gut microbiome therapeutics. Popular discourse, however, can be influenced by misinformation. With the ever-growing influence of social media, the lay reader must learn how to critically appraise the health information propagated by these sources. This second part of the gut microbiome series explores the association of the gut microbiome with human disease and the role that social media plays in influencing the popular perception and understanding of the importance of the gut microbiome. Approved and experimental therapies using the gut microbiome will be discussed.

2023 Harold Swanberg Distinguished Service Award

Joan Affleck — Thu, 14 Mar 2024 00:00:00 -0700

Joan Affleck received the 2023 Harold Swanberg Distinguished Service Award, named in honor of one of the founders of AMWA. This award is presented to an active AMWA member who has made distinguished contributions to medical communication or rendered unusual and distinguished services to the medical profession. At the 2023 AMWA Medical Writing & Communication Conference, Joan Affleck accepted the award at a plenary session and presented a MedWrite Talk entitled “Living Your Legacy.”

2023 John P. McGovern Award Address

Jessica Steier, DrPH, PMP, Andrea C. Love, PhD — Thu, 14 Mar 2024 00:00:00 -0700

The John P. McGovern Award is named in honor of John P. McGovern and is presented to a member or nonmember of AMWA to recognize a preeminent contribution to any of the various modes of medical communication. The McGovern Award is presented during AMWA’s Medical Writing & Communication Conference.

2023 Walter C. Alvarez Award Address

Katelyn Jetelina, MPH, PhD — Thu, 14 Mar 2024 00:00:00 -0700

The Walter C. Alvarez Award is named in honor of Walter C. Alvarez, MD, a pioneer in the field of medical communication. The award is presented to either a member or nonmember of the American Medical Writers Association (AMWA) to honor excellence in communicating health care developments and concepts to the public. The Alvarez Award is presented during AMWA’s Medical Writing & Communication Conference.

Next-Level QC Review and Editing in Medical Writing

Angela Trenkle, BS — Thu, 14 Mar 2024 00:00:00 -0700

Conference Education Session Report

Speaker

April Welch, ELS, Vertex Pharmaceuticals, Boston, MA

Roads Leading to Approval: The Right Level of Detail for CMC Submissions

Sidonie Jones, MA, MPhil, PhD — Thu, 14 Mar 2024 00:00:00 -0700

Conference Education Session Report

Speakers

Helen (Nellie) Forwood, MA, RAC, CQE, Associate Director Regulatory Writing, Certara, Rockland, DE

Carlos Rousselin, BS, Associate Principal Regulatory Writer, Certara, Nashville, TN

Shackleton’s Ghost Writer: Navigating the Landscape of Appropriately Acknowledging Authors

Lara Burgess, PhD, RAC — Thu, 14 Mar 2024 00:00:00 -0700

Conference Education Session Report

Presenter

Art Gertel, PhD, MedSciCom, LLC, Lebanon, NJ

Social Media Continuing Medical Education: Next Steps

Laura Tibaquirá, MA, ELS — Thu, 14 Mar 2024 00:00:00 -0700

Conference Education Session Report

Speakers

Cindy van Dijk, Principal, Scientific Communications

Allison Kickel, President and Founder, Bonum Continuing Education

Strategies to Prevent Medical Writer Burnout

Sophie Ash, BSc (Hons) — Thu, 14 Mar 2024 00:00:00 -0700

Conference Education Session Report

Speaker

Nidhi Johal, BSc (Hons), Medical Writing Director, Trilogy Writing & Consulting

Harmonies of Justice: Reflections on Virtue and Equality

George Ongoro, MS-2 — Thu, 14 Mar 2024 00:00:00 -0700

Table of Contents and Masthead

Thu, 14 Mar 2024 00:00:00 -0700

Advertisement: Trilogy Writing & Consulting

Thu, 14 Mar 2024 00:00:00 -0700

Advertisement: Synterex

Thu, 14 Mar 2024 00:00:00 -0700

Advertisement: AMWA’s 2024 Medical Communication Compensation Survey

Thu, 14 Mar 2024 00:00:00 -0700

From the Editor

Michael G. Baker, PhD — Thu, 14 Mar 2024 00:00:00 -0700

The Spring 2024 issue of AMWA Journal is dedicated to exploring trends and opportunities in medical communication, as presented and discussed at the AMWA Medical Writing & Communication Conference in November of 2023 in Baltimore, Maryland.

Generative AI in Clinical Research: Regulatory Submissions, Clinical Data Management, and Beyond

Ihab Mansoor, MBA, MSc, Javier García Ortiz, PhD, Matthew Rector, PMP — Thu, 14 Mar 2024 00:00:00 -0700

Artificial intelligence and its subsets, such as generative artificial intelligence, have been making headlines due to their potential to accelerate the growth and expansion of various industries, including healthcare. However, the majority of application areas in healthcare revolve around diagnosing diseases, finding lead molecules for potential treatments, optimizing hospital operations, and other related aspects. This means that there are areas where the potential of these technologies is still to be realized. Examples of where such technologies could produce a significant impact across multiple elements are clinical research and its related domains, including regulatory submissions, clinical data management, clinical documentation, and other closely related areas. When artificial intelligence and its related technologies are utilized in these areas, they yield unparalleled outcomes regarding efficiency, consistency, and reproducibility. This, in turn, supports professionals involved in clinical research, like medical writers, statistical programmers, and other stakeholders, to drastically improve the speed by which they produce the initial drafts of various outputs, reduce the risk of errors that could lead to submission rejection, and optimize the overall clinical research workflow. Despite the potential of this area, the number of available solutions that support the aforementioned domains remains low. This is further complicated by the fact that there are even fewer numbers of working solutions.

Upcoming Events for Medical Communicators

Thu, 14 Mar 2024 00:00:00 -0700

Using Innovative Tools and Lean Writing Workflow Processes to Accelerate Regulatory Document Writing

Thu, 14 Mar 2024 00:00:00 -0700

Lean writing workflow processes can streamline development of complex documents, including protocols and other regulatory submissions.

This paper outlines standard development timelines and describes useful lean writing workflow methods and tools to reduce protocol development timelines without sacrificing document quality.

We present the results of a survey completed by 75 Medical writers (MW) that reveal the strategies used during document preparation and use real case scenarios (protocol development) that illustrate how innovative tools and approaches can be efficiently used to create a lean writing workflow process.

Software tools (e.g., proofreading assistance, citation manager, collaborative authoring and reviewing) were widely accepted and used during protocol development according to the MWs surveyed. Most of the surveyed writers (62%) hypothesized a reduction in production time by about 25%. Efficient collaborative work across different time zones had a marked impact on shortening timelines while maintaining production of high-quality documents.

Real case scenarios were used to illustrate how innovative tools and approaches can positively impact timelines and efficiently create a lean writing workflow process regardless of therapeutic area.

The real case scenarios showed that protocol development time can be decreased by about 26% without compromising the quality of the document. This shows that software tools, templates, checklists, and collaborative writing were more impactful than hypothesized by the MWs included in the survey.

With clear workflow processes, roles, and responsibilities backed by innovative software applications, template guidelines, and collaborative work processes, MWs can overcome common development challenges and improve their lean regulatory writing skills.

The Making of the International Standard for Writing in Plain Language ISO 24495-1: Its Usefulness, Content, and How It Came into Existence

Thomas M. Schindler — Thu, 14 Mar 2024 00:00:00 -0700

There is ample evidence across many domains that writing in plain language saves time or money or both for readers and organizations. Communication in plain language is generally more effective and produces better outcomes than traditional writing. In many contexts, readers prefer plain language over traditional writing styles, and use of plain language fosters the building of trust. Finally, the process of translating is usually more efficient for plain language documents.

In July 2023, after many years of development, discussion, and alignment, the International Organization for Standardization (ISO) published a standard for plain language. This publication makes an internationally developed and agreed-upon standard available to all people interested in the use of plain language. It is an authoritative source developed by plain language practitioners, linguists, technical writers, designers, and text creators from many different countries. The standard will help all writers (authors) to make their texts (documents, web pages, etc.) most useful for the intended audiences (readers, users). It applies to most written languages and reflects the most recent research on plain language and the experience of plain language experts.

Understanding the Impact of Technology on Medical Writing: AMWA Survey Results from June 2023

Karen Rutkowski, Kenneth Shapiro, PhD, Laura Sheppard, MBA — Thu, 14 Mar 2024 00:00:00 -0700

In July 2023, the American Medical Writers Association (AMWA) developed a survey to understand the impact of technology on the role of medical writers in clinical and regulatory document development. The survey was administered using SurveyMonkey to individuals responsible for leading, training, or developing a medical writing team. Respondents were mostly regulatory writers (96%) working in pharmaceutical/biotechnology/medical device or contract research organizations (88%). Most were using technology (65%) and almost all were planning to implement authoring technology (95%). New roles for medical writers, training methods for implementation of artificial intelligence (AI), and validation of the AI output were also discussed. Quality and accuracy of the AI output were the most important considerations of the respondents with transparency and disclosure as the least important. In general, the survey respondents felt that the impact of technology in the medical writing field was an important and timely topic for AMWA to address.

Nourish Your Niche: The Rewards and Risks of Specialized Medical Writing

Alex Howson, PhD, CHCP, FACEHP — Thu, 14 Mar 2024 00:00:00 -0700

What is a niche? What are the rewards and risks of nourishing a niche? How do you find a niche? As freelance medical writers, or writers considering freelance work as an option, we have to ask ourselves what kind of medical writing we are going to do. Are we going to offer a broad mix of services or tap a specialty niche? This article will help you weigh the pros and cons of whether to specialize as a freelance medical writer and how you can get started.