Medical writing

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A medical writer, also referred to as medical communicator, [1] is a person who applies the principles of clinical research in developing clinical trial documents that effectively and clearly describe research results, product use, and other medical information. The medical writer develops any of the five modules of the Common Technical Document. The medical writers also ensure that their documents comply with regulatory, journal, or other guidelines in terms of content, format, and structure.

Contents

Medical writing as a function became established in the pharmaceutical, medical device industry [2] and Contract Research Organizations (CROs) [3] because the industry recognized that it requires special skill to produce well-structured documents that present information clearly and concisely. All new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This demand for the clear articulation of medical science, drives the demand for well written, standards-compliant documents that medical professionals can easily and quickly read and understand. Similarly, medical institutions engage in translational research, and some medical writers have experience offering writing support to the principal investigators for grant applications and specialized publications. [4] [5] [6]

The medical writing market is estimated to be USD 3.36 billion in 2020 and is growing at a 12.1% compound annual growth rate. [7]

Overview

Medical writing for the pharmaceutical industry can be classified as either regulatory medical writing or educational medical writing.[ citation needed ]

Regulatory medical writing means creating the documentation that regulatory agencies require in the approval process for drugs, devices and biologics. Regulatory documents can be huge and are formulaic. They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary documents (e.g. in Common Technical Document [CTD] format) that summarize and discuss the data a company gathers in the course of developing a medical product.[ citation needed ]

Educational medical writing means writing documents about drugs, devices and biologics for general audiences, and for specific audiences such as health care professionals. These include sales literature for newly launched drugs, data presentations for medical conferences, medical journal articles for nurses, physicians and pharmacists, consumer education and programs and enduring materials for continuing education (CE) or continuing medical education (CME). It plays a very important role in promotion of various pharmaceutical brands both to the HCPs and the consumers. Different types of communication use different media to present the writings.[ citation needed ]

Other types of medical writing include journalism and marketing, both of which can have a medical writing focus.[ citation needed ]

Regardless of the type of medical writing, companies either assign it to an in-house writer, or "outsource" it to a freelance or contract medical writer.[ citation needed ]

Organizations

Several professional organizations represent medical writers around the world.[ citation needed ] These include:

These organizations provide a forum where medical writers meet and share knowledge and experience. They promote professional development and standards of documentation excellence, and help writers find career opportunities. All these organizations offer fundamental medical writing training.[ citation needed ]

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. [11] In 1978 the BMJ editor Stephen Lock recommended Hawkins's 1967 book Speaking and writing in medicine and 4 other books. [12]

Importance of lucidity

The single most important feature of any article is lucidity. Useful guidelines are to write in fairly short sentences, keeping the words and phrases as simple as possible. Reading the article aloud is a good way of discovering how intelligible it is and some authors normally write their first drafts by using a tape recorder. It is also helpful to read articles written by masters of medical style, such as Richard Asher and William Boyd. [13]

Medical writing in social media

With the invention of the internet, social media has become a main source of information for patients concerned with certain health issues. [14] It differs from other sources through characteristics such as instantaneous and limitless reach and user-generated content. [15] Unfortunately, these aspects can lead to a lack of quality and reliability. User-generated content often leads to content written by unknown authors where the information itself may be incomplete, unreferenced, or informal. Also, unlike evidence-based medicine, social media tends to magnify anecdotal reports. [16] However, there are measures available to decrease this issue. Individuals can help lower the amount of health misconceptions online by directly disproving false or misleading claims with clear answers backed up by evidence and listed sources. [17] While the social media platform can cause communication challenges to occur when discussing health-related topics, there are certain tools one may apply to help. For example, limit the use of technical or scientific jargon. Instead, lean towards using plain, everyday language and a short and friendly professional tone. Also, identifying one's target audience will allow a more precise and relevant approach. [18] A skilled medical writer understands medical language and culture, and has the ability to use their writing platform to the best of its advantages when targeting a specific group of readers. [19]

Medical writing in freelance market

Medical writing is a growing field in the freelance market. Freelancers from a wide range of industries offer their services to clients all over the world. Medical writers specialize in creating content related to the healthcare industry. [20]

Freelance medical writers have a variety of skills and experience, and they can provide a range of services, including writing medical articles, research papers, case studies, and regulatory documents. They are often highly educated, with advanced degrees in medicine, biology, or related fields, and they have a deep understanding of the medical terminology and concepts needed to create accurate and informative content.[ citation needed ]

One of the advantages of working with freelance medical writers is the ability to review their portfolio and samples of their work. Clients can also read reviews from other clients who have worked with them in the past, which helps them make informed decisions about who to hire and ensures that they receive high-quality work.[ citation needed ]

In addition, freelance medical writers offer a range of pricing options, making it possible to find a writer who fits within your budget. Some medical writers charge by the hour, while others charge by the project. This flexibility allows clients to find a writer who can provide the services they need at a price they can afford.[ citation needed ]

See also

Related Research Articles

Documentation is any communicable material that is used to describe, explain or instruct regarding some attributes of an object, system or procedure, such as its parts, assembly, installation, maintenance, and use. As a form of knowledge management and knowledge organization, documentation can be provided on paper, online, or on digital or analog media, such as audio tape or CDs. Examples are user guides, white papers, online help, and quick-reference guides. Paper or hard-copy documentation has become less common. Documentation is often distributed via websites, software products, and other online applications.

<span class="mw-page-title-main">Editing</span> Process of selecting and preparing media to convey information

Editing is the process of selecting and preparing written, visual, audible, or cinematic material used by a person or an entity to convey a message or information. The editing process can involve correction, condensation, organization, and many other modifications performed with an intention of producing a correct, consistent, accurate and complete piece of work.

<span class="mw-page-title-main">Ghostwriter</span> Writer who writes for the credited author

A ghostwriter is a person hired to write literary or journalistic works, speeches, or other texts that are putatively credited to another person as the author. Celebrities, executives, participants in timely news stories, and political leaders often hire ghostwriters to draft or edit autobiographies, memoirs, magazine articles, or other written material.

<span class="mw-page-title-main">Clinical trial</span> Phase of clinical research in medicine

Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.

A technical writer is a professional communicator whose task is to convey complex information in simple terms to an audience of the general public or a very select group of readers. Technical writers research and create information through a variety of delivery media. Example types of information include online help, manuals, white papers, design specifications, project plans, and software test plans. With the rise of e-learning, technical writers are increasingly hired to develop online training material.

Freelance, freelancer, or freelance worker, are terms commonly used for a person who is self-employed and not necessarily committed to a particular employer long-term. Freelance workers are sometimes represented by a company or a temporary agency that resells freelance labor to clients; others work independently or use professional associations or websites to get work.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical guidelines and requirements for pharmaceutical product registration.

Copywriting is the act or occupation of writing text for the purpose of advertising or other forms of marketing. Copywriting is aimed at selling products or services. The product, called copy or sales copy, is written content that aims to increase brand awareness and ultimately persuade a person or group to take a particular action.

<i>PLOS Medicine</i> Academic journal

PLOS Medicine is a peer-reviewed weekly medical journal covering the full spectrum of the medical sciences. It began operation on October 19, 2004, as the second journal of the Public Library of Science (PLOS), a non-profit open access publisher. All content in PLOS Medicine is published under the Creative Commons "by-attribution" license. To fund the journal, the publication's business model requires in most cases that authors pay publication fees. The journal was published online and in a printed format until 2005 and is now only published online. The journal's acting chief editor is Clare Stone, who replaced the previous chief editor, Larry Peiperl, in 2018.

The American Medical Writers Association (AMWA) is a professional association for medical communicators, with more than 4,000 members in the United States, Canada, and 30 other countries. AMWA is governed by a board of directors composed of the elected officers, 6–8 at-large directors, and the chapter advisory council chair. AMWA has regional chapters and provides local networking opportunities throughout the United States and Canada. The association was founded in 1940 by physicians interested in improving the quality of medical writing and editing.

Professional writing is writing for reward or as a profession; as a product or object, professional writing is any form of written communication produced in a workplace environment or context that enables employees to, for example, communicate effectively among themselves, help leadership make informed decisions, advise clients, comply with federal, state, or local regulatory bodies, bid for contracts, etc. Professional writing is widely understood to be mediated by the social, rhetorical, and material contexts within which it is produced. For example, in a business office, a memorandum can be used to provide a solution to a problem, make a suggestion, or convey information. Other forms of professional writing commonly generated in the workplace include email, letters, reports, and instructions. In seeking to inform, persuade, instruct, stimulate debate, or encourage action from recipients, skilled professional writers make adjustments to different degrees of shared context, e.g., from a relatively accessible style useful for unsolicited contact letter to prospective clients to a technical report that relies on a highly specialized in-house vocabulary.

The American Society of Journalists and Authors (ASJA) was founded in 1948 as the Society of Magazine Writers, and is the professional association of independent nonfiction writers in the United States.

The European Medical Writers Association (EMWA) was established in 1992 in Brussels, Belgium, as a professional organisation for European medical writers, whether working freelance or in-house at pharmaceutical companies or medical communications companies. Between 1992 and 1998, EMWA was the European chapter of the American Medical Writers Association.

In drug development and medical device development the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new information as it becomes available. The purpose of the IB is to compile data relevant to studies of the IP in human subjects gathered during preclinical and other clinical trials.

<span class="mw-page-title-main">Medical journalism</span>

Medical journalism is news reporting of medical news and features. Medical journalism is diverse and reflects its audience. The main division is into (1) medical journalism for the general public, which includes medical coverage in general news publications and in specialty medical publications, and (2) medical journalism for doctors and other professionals, which often appears in peer-reviewed journals.

Medical ghostwriters are employed by pharmaceutical companies and medical-device manufacturers to produce apparently independent manuscripts for peer-reviewed journals, conference presentations and other communications. Physicians and other scientists are paid to attach their names to the manuscripts as though they had authored them. The named authors may have had little or no involvement in the research or writing process.

The AMWA Journal is a quarterly peer-reviewed academic journal and the official publication of the American Medical Writers Association (AMWA). The journal "aims to be the authoritative, comprehensive source of information about knowledge, skills, and opportunities in the field of medical communication worldwide." The current editor is Jim Cozzarin.

An authors' editor is a language professional who works "with authors to make draft texts fit for purpose". They edit manuscripts that have been drafted by the author but have not yet been submitted to a publisher for publication. This type of editing is called author editing, to distinguish it from other types of editing done for publishers on documents already accepted for publication: an authors' editor works "with an author rather than for a publisher". A term sometimes used synonymously with authors' editor is "manuscript editor" which, however, is less precise as it also refers to editors employed by scholarly journals to edit manuscripts after acceptance.

Language professionals are individuals who support authors in publishing by helping produce documents of appropriate scope and quality. Their role is particularly important in the research setting, especially when the authors are not native English speakers but are required to publish in English for international communication. The work of language professionals falls within the language industry.

<span class="mw-page-title-main">Rhetoric of health and medicine</span>

The rhetoric of health and medicine is an academic discipline concerning language and symbols in health and medicine. Rhetoric most commonly refers to the persuasive element in human interactions and is often best studied in the specific situations in which it occurs. As a subfield of rhetoric, medical rhetoric specifically analyzes and evaluates the structure, delivery, and intention of communications messages in medicine- and health-related contexts. Primary topics of focus includes patient-physician communication, health literacy, language that constructs disease knowledge, and pharmaceutical advertising. The general research areas are described below. Medical rhetoric is a more focused subfield of the rhetoric of science.

References

  1. ↑ "What is a Medical Communicator? - STC Canada West Coast". 2014-01-05. Retrieved 2021-09-15.
  2. ↑ "Writing for Medical Devices and the Impact of New Regulations". the Map. 2018-04-18. Retrieved 2021-09-15.
  3. ↑ "Outsourcing of Medical writing services to India | eMedicalMinds" . Retrieved 2021-09-15.
  4. ↑ Creswell, J.W. (2008). Educational research: Planning, conducting, and evaluating quantitative and qualitative research (3rd). Upper Saddle River, NJ: Prentice Hall. 2008, p. 300. ISBN   0-13-613550-1
  5. ↑ "Professional Medical Writing". Archived from the original on October 30, 2016. Retrieved October 29, 2016.
  6. ↑ "Adaptive Clinical Trials for Overcoming Research Challenges". News-medical.net. 16 September 2013. Archived from the original on 11 August 2020. Retrieved October 29, 2016.
  7. ↑ Markets, Research and (2021-04-12). "Outlook on the Medical Writing Global Market to 2025 - Competitive Analysis and the Impact of COVID-19". GlobeNewswire News Room (Press release). Archived from the original on 2021-09-15. Retrieved 2021-09-15.
  8. ↑ "Home". amwa.org. Archived from the original on 2020-11-15. Retrieved 2022-08-08.
  9. ↑ "Home". emwa.org. Archived from the original on 2020-11-25. Retrieved 2022-08-08.
  10. ↑ "Sign Up | LinkedIn". www.linkedin.com.
  11. ↑ "The Science Editor's Bookshelf: Some Favorite Resources of CSE Members" (PDF). Science Editor. 26 (4): 111–117. July–August 2003. Archived from the original (PDF) on 2014-09-01. Retrieved 2019-01-18.
  12. ↑ Lock, Stephen (13 May 1978). "In their own write". Br Med J. 1 (6122): 1267–1268. doi:10.1136/bmj.1.6122.1267. PMC   1604607 .
  13. ↑ Lock, S. (1970). "Writing for a journal". British Journal of Anaesthesia. 42 (9): 764–767. doi: 10.1093/bja/42.9.764 . PMID   5470060.
  14. ↑ Ferrão, Sara (December 2020). "Social media: A tool that can benefit public health?". Writing for Patients. 29 (4): 44–49.
  15. ↑ Bulaeva, Ekaterina; Iljasova, Amalia (March 2021). "Social Media Video Content for the Healthcare Industry". Medical Writing. 30 (1).
  16. ↑ Ventola, C Lee (July 2014). "Social Media and Health Care Professionals: Benefits, Risks, and Best Practices". P & T: A Peer-Reviewed Journal for Formulary Management. 39 (7): 491–520. PMC   4103576 . PMID   25083128.
  17. ↑ Trethewey, Samuel P (1 May 2020). "The FPM International Awards for Medical Writing in Social Media: A Step in the Right Direction". Postgraduate Medical Journal. 96 (1135): 304. doi: 10.1136/postgradmedj-2020-137772 . PMID   32241882. S2CID   214772913. Archived from the original on 1 May 2023. Retrieved 1 May 2023– via The Fellowship of Postgraduate Medicine.
  18. ↑ Kalthoff, Gretchen (6 November 2016). "Do's and Don'ts of Healthcare Social Media". Medical Web Experts. Archived from the original on 1 May 2023. Retrieved 27 March 2023.
  19. ↑ Oliveira, Kelsey (13 April 2023). "Content Writing for Medical Practices". Harris Ambulatory Group. Archived from the original on 1 May 2023. Retrieved 26 March 2023.
  20. ↑ Ärzteblatt, Deutscher Ärzteverlag GmbH, Redaktion Deutsches. "ÄRZTESTELLEN - Verschiedenes (gewerblich)". Deutsches Ärzteblatt (in German). Retrieved 2023-09-27.{{cite web}}: CS1 maint: multiple names: authors list (link)
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