Medical Writing: Concept, Role, and Evolution in Clinical Research

Medical writing is the activity of producing scientific documentation by applying the principles of clinical research in developing clinical trial documents that effectively and clearly describe research results, product use, and other medical information. It is the process of crafting well-structured and researched scientific documents. In the pharmaceutical world, medical writing erupted as an essential field because the industry recognized that it requires a special skill to produce well-structured documents that present complex clinical trial information clearly and concisely.

The Role and Skills of a Medical Writer

A medical writer is a person with developed writing skills, typically not one of the scientists or doctors who performed or were involved in the research. A medical writer’s job is highly profitable as well as exhilarating. He needs to work closely with doctors, scientists, pharmacists, and other SMEs to build effective documentation that clearly shows research results and the correct method to use the product.

To succeed in this field, specific skills are required, including:

• Domain knowledge and expertise in science and research fields.
• Ability to understand statistics and guidelines.
• Writing ability to produce appropriate documents for the targeted audience.
• Understanding of clinical research principles.

Main Categories of Medical Writing

Medical writing can be written in different ways categorized on the basis of purpose and specialization. The following table summarizes the primary types of medical writing and their specific document outputs:

Regulatory Documents and Safety Reporting

Most medical writers deal with technical documents that are required to get approval from regulatory agencies for medical drugs and devices. The regulatory document is a broad term that covers several critical types:

• Clinical and non-clinical Technical Documents.
• Safety reports, including PSURs (Periodic Safety Update Reports) and PADERs (Periodic Adverse Drug Experience Reports).
• ASRs (Annual Safety Reports) and expert reports.
• Package Inserts and Patient Information Leaflets.

Research and Clinical Trial Documentation

Clinical trials procedures are complex, tedious, and lengthy until they lead to market approval. This demands well-written, standards-compliant research documents such as:

• Clinical trial protocols.
• Informed consent documents.
• Research proposals and study reports.

Reasons for the High Demand of Medical Writers

The medical field has seen a huge rise in the demand for writers in recent years. Due to the rapidly changing market dynamics, expiring patents, and exhausting product pipelines, there is huge pressure on pharmaceutical companies to outsource some of their non-core activities to control expenditure and improve drug-production cycle time. Other reasons include:

1. Development of innumerable drugs and medical devices through complex procedures.
2. Increase in the number of research studies in the biomedical field.
3. Considerate regulations of more and more biomedical journals.
4. The demand for web content for medical professionals and the general public to better understand the products.

Leading professional organizations, such as the American Medical Writers Association (AMWA), founded in 1940, support writers and other communicators of medical information in this essential field.