by Laura C Collada Ali – Medical Writing & Scientific Manager, MedDev Day Scientific Coordinator at LS Academy
Medical writing is about communicating clinical and scientific data clearly and effectively. It is primarily intended for healthcare professionals, patients and their families. It encompasses various formats, including regulatory submissions, clinical trial protocols, reports, scientific papers, and marketing materials and often goes with tight timelines. Finally, medical writers take care of the rationale or significance of the medical writing that needs to be addressed – its potential impact on patient care, research, or clinical practice.
The work is diverse and medical writers are responsible for preparing various documents and information in different formats. There are two main types of medical writing:
- Regulatory writing
- Medical communications (also called ‘medcomms’)
Regulatory writing focuses mainly on the pharmaceutical and medical devices industries. Its primary audiences are professionals conducting clinical trials, governmental regulatory authorities, and the lay public. The objective is to attain and maintain marketing authorisation for new drugs, therapies, medical devices, and other health products.
Medical communications or medcomms are documents aiming to inform about new drugs, therapies, medical devices, or other health products. They span from scientific manuscripts to product monographs or conference materials.
Why is Medical Writing so important?
Janet Woodcock MD, Directors at the U.S. Food and Drug Administration (FDA):
“… we [the FDA] provide healthcare professionals and patients with the information they need to use medications safely and avoid medical errors. All these efforts require excellent medical writing”.
Melanie Carr, at the European Medicines Agency (EMA):
“… enthusiasm over good writing and sharing of ideas across the whole pharmaceutical spectrum benefits patients, the health community and society at large”.
Medical writing is essential for ensuring that regulatory bodies such as the EMA in Europe or the FDA in the US can evaluate and approve research promptly and efficiently. High-quality regulatory documents are critical for health authorities to judge the risks and benefits of a clinical program. This has implications for both the cost of marketing applications and the speed at which applications are reviewed and approved.
Poor writing can therefore delay new drugs and devices into the market increasing their cost.
High-quality medical communications are essential for doctors and other healthcare professionals who need to learn about new treatments. They acquire this knowledge from:
- Reports of clinical trials in peer-reviewed journals
- Information provided by pharmaceutical and medical devices companies
- Symposia and presentations at conferences
Patients, their families and support groups must also learn about therapy advances. Newspaper reporters and news agencies need briefings on new therapies. All these documents are developed with the assistance of medical writers who draft these bearing lay and inclusive language in mind.
Medical writers:
- Use critical thinking and are skilled at presenting complex scientific information clearly and logically to specific audiences
- Are knowledgeable about the ethical standards and regulatory guidelines that apply to preparing documents
- Are excellent at coordinating the planning, preparation, review, and finalisation of documents
- Care about caring. By having empathy, medical writers can understand their readers’ needs, concerns, and perspectives and write clear, accurate, and relevant information.
What will the future of Medical Writing be in a moment in which AI is the topic everyone is talking about?
Medical writers who can go far and beyond, who always have patients in mind when drafting their texts, will lead the market.
Minouche Shafik (Director of the London School of Economics and Political Science) said in 2018 that for future professionals, to be able to synthesise information, analyse it, and be critical about it, will be very important. In the past, jobs were about muscles, now they’re about brains, but in future, they’ll be about the heart.
Empathy can help medical writers anticipate the questions and doubts that their readers may have and address them in their writing. It can also help medical writers create content sensitive to their readership’s cultural, social, and linguistic diversity.
If you want to know more about how we deliver medical writing consultancy, please book a Zoom coffee with us!