Medical writing is both a science and an art. The art of medical writing is to comprehend and present scientific information clearly to suit the specific target audience’s level of understanding including patients, the general public, physicians and/or regulatory agencies. Often it is not poor science that kills a scientific paper; rather, it is the lack of clarity and continuity. Poor writing can be very costly to companies and frequently slows the review process of regulatory submissions.
In this 2-day course, you will learn about the different types of medical writing and how to write effectively. We will examine various types of writing including abstracts, regulatory documents, and patient education materials. We will also consider ethical issues that face medical writers. You will gain insight into the design of effective documents and what goes into putting together a compelling manuscript. You will also learn how to keep your writing free of medical jargon and common grammatical errors, while ensuring the scientific integrity of your work.
Who Should Attend
This course is valuable to those who write or review documentation in support of clinical trials and regulatory submissions. It will also benefit anyone who prepares or reviews articles or abstracts about therapeutic products for publication. The course is particularly helpful for those new to these disciplines who wish to understand the scope of medical writing. Typical attendees include medical writers, reviewers of medical documents, clinical research managers and associates, regulatory affairs professionals, project physicians and medical monitors.
Upon completion of this course you will understand:
- What medical writing encompasses
- How to assess your target audience and choose the appropriate style and tone for the reader
- How to write different types of documents
- How to write documents that meet the company’s goals and objectives
- How to use sentence and paragraph structure to give your writing clarity and impact
- How to create effective data displays (tables, charts, diagrams)
- The role of the writer in producing, proofing and issuing documents
- The best ways to manage the review process and meet timelines
- The ethical issues that face medical writers
Frequently Asked Questions
What documentation does a company need to start a clinical trial in the United States?
A clinical trial can only occur if extensive preclinical testing is adequate to show that a product is safe for testing in humans. The company must have controlled records of all product development activities leading up to testing in humans. A submission to the agency then draws upon the nonclinical documentation and summarizes it as proof of a viable test candidate. An Investigational New Drug application (IND) for drugs and biologics or an Investigation Device Exemption (IDE) for class III devices typically includes applicable forms, such as Form 3674 (Certification of Compliance); an introductory statement and a general investigational plan overview; the actual protocol; an Investigator Brochure (IB), which provides information for the investigators; chemistry, manufacturing, and controls and/or design controls; and pivotal nonclinical studies. The company must have adequate SOPs in place to cover clinical activities, such as PI and site selection, data collection, trial monitoring, and trial document management. Electronic record keeping systems for trials also require validation and the resulting documentation.
Is there a requirement for publishing in scholarly journals as we complete clinical trials?
Transparency is the reality today, and the expectation is that companies will publish results of clinical trials. The International Conference on Harmonisation (ICH) E6 Good Clinical Practice specifically calls for a publication plan as part of clinical development. Further, FDA mandates trial registration (public law 110-85, Section 810), and most journals also require registry of a phase 2, 3, or 4 clinical study on a publicly accessible database, such as clinicaltrials.gov or Eudra.Pharm.eu. These registrations link to related publications.
How can we determine authorship of the articles we publish?
The International Committee of Medical Journal Editors (ICMJE) defines authorship. “An author must take responsibility for at least one component of the work, should be able to identify who is responsible for each other component, and should ideally be confident in their co-authors’ ability and integrity…Some journals now request and publish information about the contributions of each person named as having participated in a submitted study, at least for original research” (ICMJE.org). Thus, conducting research and determining results are a basis for authorship. Other people, such as medical writers, may assist in compiling and organizing information and preparing and editing manuscripts. Such contributors deserve acknowledgement.