Unveiling the Role of Medical Writers: Insights from the Pandemic
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Chapter 1: The Profession of Medical Writing
This article is tailored for individuals who are genuinely interested in the fascinating field of Medical Writing. Here, I will explore various tasks and responsibilities that Medical Writers typically undertake, particularly in the context of the COVID-19 pandemic that began in 2020.
In my previous article, "The Mighty Medical Writer: What Do They Do?", I provided a high-level overview of this profession aimed at those unfamiliar with the role. If someone expresses confusion upon hearing you're a Medical Writer, that previous post is for them. However, this piece is designed for those contemplating a career in Medical Writing and eager to understand the specifics of our daily responsibilities.
To make this exploration relatable, I want to frame Medical Writing within a context that resonates with most people. Given the widespread impact of COVID-19, discussing the role of a Medical Writer through this lens should feel familiar and engaging.
Let’s rewind to early 2020, when the World Health Organization declared COVID-19 a global pandemic. Researchers globally collaborated to find preventive measures and treatments. Pharmaceutical Research and Development (R&D) initiated the rapid development of candidate vaccines, leading to unprecedented clinical trials.
And thus begins the journey of a Medical Writer and the vital work we perform.
Chapter 1.1: Advisory Boards
Following the identification of the SARS-CoV-2 virus, Moderna partnered with the National Institute of Allergy and Infectious Diseases (NIAID) in January 2020 to create an mRNA vaccine for COVID-19. They convened a group of infectious disease experts for an advisory board, seeking their insights on the execution of their initial clinical trial for the mRNA-1273 candidate vaccine. Numerous topics were debated, including participant recruitment criteria, methods for measuring vaccine efficacy, and confirming positive SARS-CoV-2 test results.
In this scenario, a Medical Writer is quietly taking extensive notes at the meeting while wearing an N95 mask. Shortly after, they draft a comprehensive report that guides Moderna on conducting their first Phase 1 clinical trial.
Section 1.1.1: Clinical Study Protocols
In March 2020, Moderna initiated the Phase 1 clinical trial for mRNA-1273. Before patient recruitment commenced, it was crucial for the trial to be conducted ethically and transparently, adhering to the International Council of Harmonisation (ICH) Guidelines for Good Clinical Practice.
A Medical Writer in this context compiles a detailed clinical study protocol that defines the trial's design, eligibility criteria, vaccine administration process, data collection methods, and analysis plans, among other critical considerations. This type of Medical Writing falls under regulatory writing and follows a structured format intended for study investigators. The Phase 1 study protocol is publicly available and spans 69 pages.
Section 1.2: Congress Abstracts
By May 2020, during the Phase 1 trial, Moderna reported encouraging interim results. The investigators aimed to present these findings at the International Congress of Infectious Diseases 2020 (which was ultimately canceled). These conferences serve as platforms for healthcare professionals to learn about significant medical advancements, often followed by publication in peer-reviewed journals.
To secure a presentation slot, an abstract must be submitted to the congress committee for review. Medical Writers collaborate with primary investigators to create this abstract, which generally consists of 250-400 words, summarizing the study's significance and results.
Chapter 2: Presentations and Reports
Upon acceptance of the abstract, a Medical Writer must prepare either an oral PowerPoint presentation or a poster presentation. This involves multiple drafts in collaboration with the authors to ensure clarity and conciseness.
Oral presentations typically last 10-15 minutes, and poster presentations are limited to a single page, necessitating the selection of key information presented succinctly. The goal is to effectively communicate vital findings about the vaccine’s efficacy and safety to healthcare professionals.
With positive interim results from the Phase 1 trial, Moderna proceeded to the Phase 3 COVE clinical trial in July 2020 to validate their findings among over 30,000 participants. By November 2020, interim results were available, necessitating the creation of a Clinical Study Report (CSR). This extensive document consolidates the data and findings and plays a crucial role in regulatory evaluations.
Medical Writers are involved throughout the process, from drafting manuscripts for peer-reviewed journals to creating promotional materials and educational content aimed at both healthcare professionals and the general public.
In summary, Medical Writers play a critical role in various projects, tailoring content for different audiences while ensuring accuracy and compliance. If you have any questions about this field, feel free to reach out!
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