Medical Writing Approaches: Key Differences Between Regulatory, Publication, and Commercial Writing

Overview of Medical Writing

In the fast-paced and dynamic world of pharmaceutical industry, effective communication is foremost. Medical writing plays a pivotal role in bridging the gap by translating complex scientific data into accessible information to a wider audience.

Medical writing is a diverse and specialized field that contributes significantly to drug development, regulatory compliance, patient communication and overall patient safety. Opportunities for medical writers are growing day-by-day. The U.S. Bureau of Labor Statistics predicts that the field of technical writing will grow by 7% by 2032, a rate that is faster than average.¹ Whether the aim is to secure regulatory approval for new drug, to share ground-breaking research to the scientific community or craft compelling marketing material, understanding the difference between regulatory, publication and commercial writing is important.

This blog will explore about these three approaches providing insights into the unique characteristics and skills required to get success into each area.

Regulatory Writing: The backbone of compliance

Regulatory writing is crucial in clinical research for writing relevant documents for various authorities. The primary goal is to obtain approvals for new drugs, medical devices and therapies. Regulatory writers perform a central role from the development of protocols to filing and approval of drugs.

The most frequent clinical documents written by regulatory writers are Investigator Brochures (IBs), Clinical Study Protocols, Clinical Study Reports (CSRs), New Drug Applications (NDA)/ Marketing Authorization Applications (MAA) and the Common Technical Document (CTD). They also produce for the patients’ own documents like the clinical trial lay summary, patient’s information to be given before participating in a clinical trial and the informed consent form

The writing style for regulatory documents is precise, objective and highly structured. Clarity and consistency are paramount, even minor error can lead to delays in approval or request for additional information.

Key skills for regulatory writers include:

• Attention to detail: Ensuring minute details are accurate and complaint with regulatory standards
• Analytical Thinking: Subject to analyse complicated data and present it in clear and concise manner
• Understanding of Regulatory Guidelines: Familiarity with guidelines such as International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) together with agency requirements.

Publication Writing: Sharing knowledge with the scientific community

Publication writing has a primary aim of making information derived from research available to scientific and healthcare communities. The publications must be clear, accurate and precise regardless of being a manuscript for a peer-reviewed journal, a poster to be presented at a conference or an abstract.

In addition to the core content, publication extenders play a crucial role. This supplementary material such as extended data sets, appendices, extended data tables provide additional information and context that supports primary publication. They help enhancing the depth of the study. Additionally, Plain language summary for publication (PLS-P) helps in translating the complex scientific information to simpler language for patients and non-specialists, ensuring that key findings are understood by all stakeholders.

These publications are directed towards the intended users which are healthcare professionals, researchers, and academics; therefore, these works should be scientifically substantiated, unprejudiced, and clear.
The tone of publication writing must be scientific, accurate, concrete and most of all, backed by evidential data and result. The writing should be without the flair of either side and should endeavour to advance knowledge in the scientific realm.

Key Skills Required

• Scientific Literacy: A good scientific approach, research methodology and methods of data analysis
• Critical Thinking: capability to evaluate research findings and interpret in context of broader scientific context
• Writing Clarity: Translating intricate data into simpler and concise manner to be understood by experts and non-experts alike.
• Ethical Awareness: Understanding basic of ethics, refer to the authorship and conflict of interest statements and data accuracy.

Commercial Writing: Crafting Persuasive and Engaging Content

Commercial writing in the medical field focuses on both communication and persuasion. Its aim is to create content that not only informs but also engages and motivates various audiences, whether they’re healthcare professionals, patients, or the general public.

The main goal of commercial writing is to promote products, services, or brands. Depending on the audience, this might involve providing detailed product information for healthcare professionals or creating understandable and reassuring content for patients about their treatment options.

The tone in commercial writing is usually persuasive and engaging, but it also needs to be precise and adhere to regulatory standards. It should connect with the audience effectively, whether that means making a compelling case to healthcare providers or offering clear and empathetic information to patients.

Key Skills Required

• Creative writing simply means ability to write engaging content is crucial for conveying key messages
• Marketing Insight: Target audience, market dynamics, product positioning.
• Regulatory literacy: Writers must ensure that promotional material complies with legal and regulatory standards.

• Cross-functional Collaboration: Working closely with marketing teams, legal departments, and medical reviewers to develop effective and compliant content.

Guidelines and Principles Governing Regulatory and Publication Documents

Publication writing concentrates on conveying scientific integrity which are driven by different institutions under a global community. International Committee of Medical Journal Editors (ICMJE⁾² outlines on publication transparency, and authorship criteria. The International Society for Medical Publication Professionals (ISMPP) has also published a set of good publication practices (GPP)³ guidelines updated in timely manner.

Moreover, regulatory medical writing works under specific rules and guidelines laid by ICH, The guidelines ensure that the quality of all the scientific and technical requirements for registration are consistent throughout global network.

The ICH-specified guidelines are divided into four categories: quality, safety, efficacy, and multidisciplinary. Some of the critical guidelines include E3 (Clinical Study Reports), E6 (Good Clinical Practice), and M4 (Common Technical Document). Many templates are available on the ICH website for the use by regulatory writers.

Conclusion

Regulatory, publication or commercial writing overlap in some respects but are aimed at different audiences, so each type of medical writer needs to focus on developing the required set of skills for their intended audience. Regulatory writing is about the precision and compliance, publication writing needs scientific rigor and clarity while commercial copywriting requires persuasion & engagement. Similarly, each type of writing needs a completely different skillset with details to attention and scientific literacy for academic content creation or creative thinking process as well as the market insight in marketing based on your choice. As the field continue to grow, the demand for skilled medical writer who can navigate these approaches will only grow, making this an excited and dynamic career path.

References:

1. (2024, June 24). How to become a medical writer. American Medical Writers Association. Accessed from https://blog.amwa.org/how-to-become-a-medical-writer on August 8, 2024.
2. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. Accessed from https://www.icmje.org/icmje-recommendations.pdf on August 13, 2024.
3. DeTora LM, Toroser D, Sykes A, et al. Good Publication Practice (GPP) guidelines for company-sponsored biomedical research: 2022 update. Ann Intern Med 2022 Sep;175(9):1298-1304. doi: 10.7326/M22-1460.

Authors:

Manasvi Joshi, Msc in Biotechnology
Senior Scientific Writer 1, Enago Life Sciences
Connect with Manasvi on Linkedin

Dhanya Mukundan, MDS (Oral Medicine and Radiology)
Expert Scientific Writer, Enago Life Sciences
Connect with Dhanya on LinkedIn

Raghuraj Puthige, PhD., eMDP
Function Head, Medical Communications – Enago Life Sciences
Connect with Raghuraj on LinkedIn