Presented by Nancy Katz and reviewed by Monica Hacopian
Nancy Katz, an accomplished medical writer who is the President & Principal Medical Writing consultant at Illyria Consulting Group, Inc., presented information about medical writing and the type of documents medical writers create. Nancy shared several key points such as defining the role of the medical writer, explaining deliverables created by medical writers and highlighting the competencies required to break into the business.
Who are Medical Writers?
Medical writers create clinical regulatory content for the biopharmaceutical industry. They should be dedicated to understanding the process of clinical and drug trials and they should also have the acumen for interpreting quantitative data and translating it into accurate and concise messages. There are two approaches to developing regulatory content. In most cases, medical writers are individual contributors who own the document and work closely with physicians and biostatisticians to form the report. In other cases, physicians driving the trial own the document and call upon the medical writer to assist with editing.
The FDA requires several essential documents, assembled as a comprehensive unit.
The following is a partial list of FDA-requested documents created by medical writers:
- Protocols and amendments — An overview of how the clinical study is conducted and an explanation of what happens to drugs when they are administered to subjects.
- Investigator brochures — A summary of the drug development process for specialists in the field.
- Briefing packages — Background information about the drug trial, quality information, the chemical structure of the drug, and how the drug is packaged (i.e., tablet, IV, placebo).
- Clinical study reports — The overall clinical trial plan, including safety considerations and patient data.
- Integrated summaries of safety and efficacy — A report that identifies the safety of the drug and any adverse effects (side effects).
- Module 2 summaries of the Common Technical Document (CTD) — The primary document that contains overviews and summaries for clinical and nonclinical data.
The FDA “highly recommends” that all regulatory documents be submitted by eSubmission, where they are linked via an XML backbone. This allows reviewers instant access to all the documents in the drug application and allows readers to easily click through the submission. In addition, everything is packaged onto five DVDs to reduce paperwork and avoid the loss of data. Katz pointed out that writers with technical knowledge in XML can find work specializing in preparing the deliverables for submission.
Medical writers should have what Katz referred to as an “intuitive awareness if the message derived from the data is correct.” This is accomplished by data immersion. In other words, getting a good “feel” for the data and understanding how statistical data is produced and presented (in tables, lists and figures). Working closely with biostaticians, who maintain the integrity of the clinical trial data, medical writers translate quantitative data into accurate qualitative statements.
Medical writers should also:
- Understand the guidelines for integrated summaries and for clinical study reports (CSRs).
- Identify the type of applications developed by biopharmaceutical companies.
- Use appropriate templates and effectively re-use or “repurpose” documents that conform to agency standards.
- Work as part of a team consisting of highly-specialized members in the field.
- Successfully manage multiple projects and timelines.
- Understand and anticipate the processes and requirements of QA.
To acquire these competencies, Katz recommended the following to help familiarize yourself and conform with industry standards:
- Medical Dictionary of Regulatory Activities (MedDRA)
- World Health Organization Drug Dictionary (WHO Drug)
- Clinical Data Interchange Standards Consortium (CDISC database)
- Style guides (AMA Style Guide, Chicago Manual of Style, “eccentricities of a sponsor’s style)
Though medical writing is a specific field, technical communicators already have many transferrable skills. For instance, managing large amounts of technical information and turning it into clearly written and usable documentation. You do not have to be a scientist to write medical documents. However if you wish to transition into medical writing, you must be serious about learning about drug development, understanding how the Common Technical Document is structured, and always telling the truth in your reports.
Start your research and education about drug development through the following professional associations:
- American Medical Writer Association (AMWA) – They offer a certification program which is respected in the field
- Drug Information Association (DIA)
- Pharmaceutical Educational Research Institute (PERI)
- Regulatory Affairs Professionals (RAPs)
You can also gain additional knowledge about writing reports by reading real clinical documents. At the end of her presentation, Katz showed us a real clinical study report for a drug called Paroxetine atwww.gsk.com/media/paroxetine.htm. Here you will also see how the document is formatted for online delivery.
In addition, take advantage of networking and social media opportunities to gain exposure and make new contacts. You can start by attending professional meetings, creating a LinkedIn profile, conducting informational interviews with colleagues, and joining the Bay Area Biomedical Consultants Network (BABCN).
Katz also suggested showing your dedication to the field by attending the AMWA’s annual conference, which will be held in Sacramento, CA this fall. For more information visit http://www.amwa.org/default.asp?id=548.
Monica Hacopian is a technical communicator and editor in San Francisco.