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Introduction to medical writing

Medical writing is the making of scientific documents by the specialized writers. Generally a medical writer closely works with scientists, doctors and other subject matter experts in order to create effective documentation that intensely defines research results and product’s usage.

“New knowledge and insights are increasingly being applied to the medical field through an  ever-increasing number of research trials, through clinical experience and new ideas and innovations. All this information needs to be conveyed effectively to multiple stakeholders, such as doctors and other healthcare professionals, patients and customers and drug regulators.

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Medical writing is the discipline of writing scientific documents by the writers in the field of medicine – the “medical writers”.

Medical writers may not be the original scientists who did the actual research, but they collaborate with the doctors / scientists involved in data generation and help to present the knowledge in a way that is relevant.

The importance of good medical writing cannot be ignored as science depends on clear and accurate reporting – otherwise, meticulous research can appear flawed if it is poorly presented.

The medical writer needs to have a clear understanding of the scientific concepts and ideas and be able to present the data and their meaning in the way that the target audience understands it.

Health authors incorporate their knowledge of science with their interpretation of study to present information to the target audience at the appropriate level. In addition, writing must fulfil the specific requirements for various types of documents.

Medical writing has become an important function in the pharmaceutical industry because it requires specialized knowledge and skills in order to be able to write well-structured and clearly presented scientific documents. In the last few years, the market for medical writing has increased considerably.

The reasons for this are numerous  more research studies are being carried out in the biomedical field today; pharmaceutical companies are creating more new drugs and medical devices, and several scientific papers need to be created for submission to regulatory authorities during their approval process; the number of biomedical journals has gone up considerably and many more scientific articles are now published than before; similarly, with the addition of a new and a powerful medium like the ‘internet’ the lot of medical information is generated as ‘web content’ for medical professionals as well as for the general public.

 The medical writing market has doubled in size in the last five years, up from an estimated $345 million in 2003 to $694 million in 2008, according to the CenterWatch analysis. Furthermore, medical writing is also the fourth most commonly outsourced service according to a separate study.

When pharmaceutical companies outsource more and more research to Asia, Indian students should look to medical writing as a viable career option, and learn the knowledge and skills needed to take this up as a full-time.”

Types of Medical Writing

“Medical writing involves writing different types of the documents for different purposes and for different audiences. Following are examples of different kinds of medical writing:

Medical Journalism: Health news is the presentation in mass media of health and medical reports and the subjects related to health.

Through delivering health-related information through mainstream media outlets it reaches the general public, rather than particular professional groups.
Articles in newspapers & magazines.

These are mostly written in a simple, non-technical language for the general public and laypeople.

Medical Education: For Physicians – textbooks, Continued Medical Education (CME) programs, slide decks, e-learning modules For the Patients – patient education material

Medical marketing of healthcare products:  Promotional literature targeted at the healthcare professionals, product monographs, brochures, handouts. Salesforce training manuals, e-learning modules Internet content for the physicians and patients (consumers)

Publication/Presentation: Journal articles / manuscripts (research articles, case reports, review articles) Abstracts Posters & presentations for scientific meetings and conferences

Research Documents
Clinical trial protocols
Informed Consent Documents
Research proposals
Investigators′ Brochure
Study reports

Regulatory Documents
Package Inserts (prescribing information) & Patient Information Leaflets
Clinical study reports, web synopses
Subject narratives

Regulatory submission documents – Common Technical Document (CTD) modules such as non-clinical and clinical overviews & summaries, expert reports, safety and efficacy summaries;  aggregated safety reports such as Periodic Safety Update Reports (PSURs), bridging reports,  Periodic Adverse Drug Experience Reports (PADERs), Annual Safety Reports (ASRs); policy papers, etc.

Each of the above types of medical writing is intended for a particular audience, e.g. medical professionals, patients & the general public, members of medical sales or drug regulators.

The language used and the level of technical information must, therefore, be appropriate to the level of comprehension of the respective audience.

For instance, while documents intended for medical professionals and regulators can be highly technical and include scientific data and their interpretation, those intended for patients and the general public need to be simple and free of technical jargon.

Therefore, regulatory submission documents are expected to meet the specified formats and frameworks, and their content is governed by regulatory rules and guidelines.

A medical writer who is interested in preparation of these documents therefore needs to be  familiar with the laws and approved formats for such documents.

Therefore, it is likely that the knowledge and skills required to write various types of medical documents are different, and  one may chooses to specialize in a particular type of medical writing, based on one’s aptitude  and  like.”

Organizations:

Several professional organizations represent medical writers around the world. These include:

American Medical Writers Association (AMWA): “AMWA is a professional association for the medical communicators, with more than 4,000 members in the U.S., Canada, and 30 other countries.

AMWA includes a variety of medical communicators, including administrators, advertisers, authors’ editors, college and university professors, journal editors, pharmaceutical writers (and those involved in pharmaceutical publication planning), public relations specialists, publishers, reporters, researchers, statisticians, and translators.

Many members are freelance writers and editors. Membership in the AMWA is open to anyone interested in any aspect of medical communication. AMWA’s headquarters are located in Rockville, Maryland, United States”.

Australasian Medical Writers Association (AMWA)

• European Medical Writers Association (EMWA)

• Indian Medical Writers Association (IMWA)

• Chinese Medical Writers Community (CMWC)

“These organizations provide a forum for medical authors to meet and share knowledge and experience. They encourage quality in professional development and reporting practices and help writers find career opportunities. All of those entities offer basic instruction in medical writing.

Who requires medical writers?

Media writers work mostly with the pharmaceutical industry. Nonetheless, there are many other situations where you need medical writers:  Pharmaceutical /healthcare services firms including medical device companies Contract research organizations (CROs) & Business / Knowledge process outsourcing firms (BPOs / KPOs) Scientific information and healthcare service providers (Functional Service Providers) Press & Publishing firms and Scientific Journals Educational medical institutions, Research / scientific Societies.

Healthcare Websites

So the scope is tremendous and growing for medical writers. This is also an occupation that can be pursued separately either as a freelancer or as an employee in an organisation, depending on one’s background, level of expertise and like. Taking medical writing can thus be the beginning of a career that lasts for life.

Requirements for becoming a Medical Writer

Of course, familiarity with medical concepts and terminology is the basic prerequisite for becoming a medical writer.

An academic qualification in one of the life sciences such as medicine or paramedic sciences such as pharmacy, microbiology, nutrition and dietetics, biochemistry, and biotechnology can provide the right background to familiarize the writer with scientific concepts and data from research Another important prerequisite is writing ability.

Since a medical writer’s basic requirement is to communicate scientific information to the target audience, it is most important to have some degree of command over the language, reflected in the ability to write grammatically correct text, and the ability to express and present information clearly and succinctly.”

General Knowledge and Skills

  • Language & grammar: “A medical writer must pass on scientific information. Besides understanding the scientific aspects, the writer needs to present the information in a clear manner and at an appropriate level of understanding for the target audience.

Use of grammatically correct language, simple and short sentences, active voice, adequate punctuation marks and a logical flow of ideas can go a  long way in making the information readers understand. Especially for the non-medical audience, avoiding the use of highly complex technical jargon also makes writing more lucid.

  • Literature/reference searching: There’s now a massive amount of scientific information available in the public domain. Databases such as Medline, PubMed, EMBASE, Micromedex are commonly used for the sourcing of medical information in addition to books and medical journals.

 Looking for information relevant to your purpose through all medical records and health-care pages is like looking for a proverbial needle in the haystack.

Keep in mind what exactly you are looking for, know where to search and select only the authentic sources, plan your search strategy, use the correct keywords to search and then perform the search according to the set plan is more likely to generate useful information.

It is equally important to analyze your search results and determine whether the information is relevant and to regularly identify and file useful information for later retrieval.

Interpretation and presentation of research data

Writing scientific papers involves reviewing and interpreting research data, presenting such data in text, tables and graphs, and developing a logical discussion and conclusions on what the data means.

Medical writers need to have sufficient knowledge of the research topic, and should be able to understand the research design and data in order to explain and present it to their readers”.

Ethical & legal issues: Issues of concern to scientific authors include – presenting accurate and complete information including adverse results, following copyright laws, not indulging in plagiarism, meeting authoring requirements for research papers, and adhering to journal review processes. So, what makes a good medical writer? The following qualities differentiate a good medical writer from a mediocre one:

 • Ability to understand the reason and requirements of the project

 • Ability to write at a level suitable to the target audience

 • Thorough research of the subject

• Ability to think, logical organization of thoughts and ideas

• Scientific accuracy

 • Ability to work across teams (often remotely) as well as independently

• Good communication & coordination with different people involved in the process

• Attention to details

• Good time management and meeting deadlines and commitments

Steps in writing scientific documents

  • Understanding the project brief: “Before you start writing, the medical writer needs to understand the purpose of the document being written and what the sponsor wants to achieve through it.

 In addition, the timelines to be followed, the data to be studied and the review/approval process to be followed need to be known.

  • Literature search & review of information: Adequate preparation and time spent on reading and analyzing literature will provide valuable information that a professional writer can use to validate the text being written properly.
    A proper search strategy and sorting into accessible chunks of the collected information is very critical.
  • Authoring & compiling the document: The drafting of the document’s first edition usually takes the most time. Creating the draft involves familiarity with the type of text, its purpose and its contents. The use of a predefined template simplifies the work. Having adequate language skills and adopting the in house or company style guide at this juncture, apart from the scientific part of the text, is useful for minimizing subsequent review and revision times. The paper may contain a number of appendices, in addition to the main text. Nevertheless, it is the duty of the medical writer to ensure that the final version of the text is compiled with accurate and relevant appendices.
  • The review process: Scientific document review process involves content review and editorial/formatting review. The former is typically done by a senior medical writer with more experience, and a specialisation the subject matter who may be an expert in the clinical or therapy field.
    Also required is quality control (QC) of contents involving the cross-checking of all verifiable information with the source data.
    Typically this is performed by a pair of scientific doctors. The medical writer must, however, do a comprehensive ‘self-examination’ of the document’s first draft  before it goes for further inspection.”
  • Formatting & editing: “Formatting (checking text font and size consistency, line and paragraph spacing, headers and footers, margins, page numbers, etc.) and editing (speaking, e.g., U.S. or British English, spelling, punctuation marks, correct use of tense, appropriate reference style, etc.) of documents is a skill that every writer needs to learn to make their document more presentable and acceptable.

    Reports that are needed for publication or electronic publishing must be carefully edited, proof-read and reviewed for specifications for formatting.
  • Approval and sign off: All scientific papers require approval and sign-off from the appointed approver, typically an expert. The approver may be in house or external, and the approver must be given sufficient time to review the document and sign it off.
  • Electronic publishing: Electronic publishing is about making the material available for online access in digital format. There are now a number of software tools available for e-publishing, and a modern-day medical writer may need to be familiar with their use.

Training and Professional Resources for Medical Writers

There is no formal degree / diploma, or medical writing certification course. Training in this discipline usually involves

1. In house training organizations that hire medical writers typically provide new recruits with the requisite general and project-specific training.

This may include training in the process of drug development (Type of clinical studies, Phases of trials, efficacy, effectiveness, bridging studies etc) exposure to drug safety and medical statistics, various types of regulatory documents and their requirements, as well as in house templates, work processes and style guides.

Related: How to Become a Medical Writer in 2020
Medical writing Module 2: Epidemiology and Evidence-Based Medicine

2. Short courses/workshops by professional bodies can organize one or two-day training courses or workshops on specific topics, e.g. CSRs, writing protocols, or statistics etc.

3. Education ‘ mentor guided ‘ on the job this is usually given by a senior medical writer who is more experienced in writing various types of papers.
Education focuses more on specific types of documents that are managed by the organization.

4. Motivated “self-study” this is the pillar of preparation for a medical researcher. A writer who is self-motivated and knowledgeable can do a great deal in educating him/herself on different types of medical writing”.

Books on medical writing

“Stephanie Deming of the Council of Science Editors compiled in 2003 a list of books that might be helpful in medical and/or science writing. In 1978 the BMJ editor Stephen Lock recommended Hawkins’s 1967 book Speaking and writing in medicine and 4 other books.”

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