Clear, readable medical writing verifies product integrity. It provides a history of product development as companies publish study results in professional journals and submit documentation to regulatory agencies. If the writing is good, it is also cost effective. In the clinical setting it can help prevent the need for additional costly clinical trials, which agencies can require if documents don’t accurately reflect sound science or technology. Poor writing frequently slows the review process as well as regulators ask for clarification and additional documentation, while well-written submissions optimize the review process and increase the amount of time a product remains under patent protection. This course provides an overview of how to present product information clearly and concisely for targeted audiences. Hands-on exercises reinforce the course content.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
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 professionals who prepare or review articles and abstracts about therapeutic products in any phase of development for professional publication. The course is particularly helpful for those new to the discipline 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 write documents that meet the company’s goals and objectives
- Why publishing is an essential part of therapeutic product position
- How to write an abstract or manuscript
- How to control sentence structures for precise delivery of data
- How to increase clarity and effectiveness through tone and voice
- How to create effective data displays
- The role of the writer in producing and issuing documents
- How to overcome Writer’s Block
- How to produce documents within controlled timelines
- The best ways to manage the review process
- What kind of feedback is useful to other writers
- How to reach concurrence in the review process
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.