What value does medical writing bring to the study team?

Introduction

To the unaware eye, a medical writer is just an intelligent person with good writing skills. This assumption is as simplistic as believing finger movement is the only prerequisite to becoming a violinist. Recognizing the role and value of professional medical writing across the healthcare ecosystem can be challenging. With a diverse and non-standardized training path,¹ professional medical writing has a broad and ever-evolving definition.²

As an orchestra conductor guiding a concert, the professional medical writer leads the preparation of specialized and compliant information targeted to an audience in need. Audiences are as broad as music genders and include regulators, health care practitioners, researchers, and patients. The content, style, format, and tone of the medical information they need are different. However, prioritizing the transparency, accuracy, and usability of the information is a common and distinctive hallmark of every medical writing activity.²

But how to achieve these requirements and deliver high-quality and effective communication material? With a typical evolving craft, the medical writing process brings irreplaceable value and essential contributions to the team.

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Communication contributions

Strategy

Our brains are naturally “cross-wired” for flexibility and adaptability during social communicative interactions.³ Despite being a wonderful evolutionary skill for creativity, it imposes challenges for structured evidence-based decision-making in multidisciplinary teams.

The medical writing process is the Ariadne’s thread that connects the research data dots to the key message for a given audience in a maze of information. By being aware of the audience's needs, the professional medical writer develops dynamic strategies for effectively disseminating the medical narrative. How this is achieved varies across the different types of medical writing activities.⁴

For example, before a continuing medical education (CME) program is developed, the medical writer produces a needs assessment describing the gap between current and best clinical practice. This analysis justifies the need for healthcare practitioners’ education.⁵ Needs assessments are an essential piece in securing educational program funding and extend beyond mere literature reviews and industry agendas. Wearing the detective’s hat, the medical writer collects needs data from physicians, patients, and payers, and applies root-cause analysis to link the educational needs to their causing factors. This tactical and tailored approach can increase the success likelihood of a CME grant proposal, and ultimately the effectiveness of the learning program.^6,7

The medical writing process sets the stage for asking the “what”, “when", and often the essential “why” questions. Then, the answers provide the road map to efficiently delivering the medical content. This is the first step in a straightforward and effective communication program. It comes down to the Toyota Way of “The Right Process Will Produce the Right Results”.⁸

Crafting

After developing the strategy, the life cycle of the communication material starts with selecting the most relevant resources and data. With the current diverse and fast-paced information flow, this is easier said than done.⁹ This implies having a critical understanding of clinical and scientific research, statistics, applicable guidelines, and therapeutic indications, to name just a few.

The professional medical writer gathers each piece of data to build a “story not a storage” type of document;¹⁰ a smooth narrative that is accurate, easy to read, and comprehend for a specific reader. Words are pointers to concepts; the more explicit and structured they are, the more readable and usable the document will be.¹¹ To this aim, outlining the content and providing structured headings can help the user navigate the communication material.

Also coming from the Japanese culture, the art and meaning of sharpening a samurai sword depicts the value of editing during the medical writing process. “Our blade is honed only on a single edge. Why? It is because with the dull edge against our flesh, the katana becomes our shield”.¹² Ensuring compliance with applicable guidelines becomes the crucial shield for the approval and dissemination of medical information. Reviewing and correcting the document to guarantee accuracy, consistency, and adherence to the intended audience is the sharp edge for effective and efficient communication.

Management

The craftsmanship of medical writing is all about managing communication processes, leading and liaising with cross-functional team members, throughout the material’s life cycle. This is far from the idyllic writing life of being left alone with your thoughts in a cosy mountain cabin. The professional medical writer needs to embrace the leadership in building united teams that can deliver high-quality materials on time. ¹³

Becoming a leader is not an easy goal for many. It requires interpersonal skills to facilitate conflict resolution or adaptability when facing the unexpected. Achieving joint decisions and finding consensus after disagreement requires the leader to wear the negotiator’s hat. As a communication activity, negotiation benefits from Aristotle’s persuasion theory of building logical (logos) and truthful (ethos) arguments.¹⁴ The medical writing process of designing, crafting, and managing the communication material provides the source from which such an argument can be built.

Finally, disseminating medical content would not be possible without an efficient medical writing process of managing tasks, timelines, risks, and responsibilities of internal and external contributors.

Conclusion

Medical writing goes beyond its name. As a communication process, it provides the context in which clear and useful medical information can be designed, crafted, and managed. It is the assembly line of new scientific and medical evidence that pharmaceutical companies, medical education, and communication agencies, as well as research institutions, need to disseminate toward the ultimate goal of improving health care.

References

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2. Lang T. Medical writing up close and professional: establishing our identity. AMWA Journal. 2015;30(1):10-17.

3. Hirsch J, Noah JA, Zhang X, et al. A cross-brain neural mechanism for human-to-human verbal communication. Soc Cog Affect Neurosci. 2018;13(9):907-920.

4. Singh N, Chang C, Chachati V, et al. Career guide for new medical writers. 2023 [cited 2024 September 24]. Available from: https://www.emwa.org/media/5072/emwa-writing-guide-2023-high-res-1.pdf

5. Parry NMA. The needs assessment in continuing medical education. Medical writing. 2014;23(2):125-128.

6. Van Hoof TJ. CME planning series: article one of five, conducting a needs assessment. Connecticut Medicine. 2008;72(8):477-480.

7. Write Medicine© podcast. 2024, June 5. Elevate your CME Game: Insider Secrets from Kristen Dascoli to Transform Education Programs. Available from: https://www.writemedicine.com/elevate-your-cme-game-insider-secrets-from-kristen-dascoli-to-transform-education-programs/

8. Liker, JK. The Toyota way: 14 management principles from the world's greatest manufacturer. New York: McGraw-Hill; 2004.

9. Harting D, Bowser A. Worst practices for writing CME needs assessments: results from a survey of practitioners. AMWA Journal. 2019;34(2):51-54.

10. Drees B. Lean medical writing: story not storage. 2021 [cited 2024 September 24]. Available from: https://trilogywriting.com/document/lean-medical-writing-story-not-storage/

11. Ludwig-Begall L. Can scientific documents be easy to read? Medical writing. 2023;33(2):64-65.

12. Matsuoka T. Cloud of sparrows. New York: Delacorte Press; 2002.

13. Harris D, Tyrrell C, Myers A, et al. Value of medical writing: the regulatory writer´s perspective. AMWA Journal. 2021;36(4):152-158.

14. Arvanitis A, Karampatzos A. Negotiation and Aristotle´s rhetoric: truth over interests? Philos Psycol. 2011;24(6):845-860.