Whether it’s a clinical study report (CSR) for a single clinical study or a Clinical Overview that summarizes a complex clinical development program, it’s often best to consider who you’re writing for at the very start of a writing project. Regulatory medical writers typically have one ultimate audience: the regulatory agencies (e.g. FDA, EMA, PMDA) and the subject-matter experts at those agencies who are reviewing the various portions of the submission (e.g. clinical, statistical, or CMC reviewers).
We’ve put together a list of tips to keep in mind when writing for a regulatory audience.
Each document is “fit for purpose”
Throughout the various stages of drug development, various documents will fill various roles. What should a reviewer know about your drug, your program, or your indication to evaluate the safety and effectiveness of the treatment?
For example:
- Development Safety Update Report (DSUR): have you summarized the safety data in a way that provides a comprehensive evaluation of the safety profile of the drug being studied?
- Clinical Study Report: are the objectives of the study supported by your conclusions?
- Clinical Overview: Taken together, does the summary of all key data support the ultimate benefit-to-risk ratio? Are there issues raised by any of the data and have these issues been fully addressed?
Each document most likely has an associated regulatory guidance, but experience is key!
Regulatory authorities (FDA, EMA) may have specific regulatory guidances that can aid the medical writer in understanding the required content of documents such as CSRs and DSURs. However, as these guidances are just that – guidances and not rules – it’s ultimately up to the medical writer to gain experience with different document types and to gain knowledge of what content is required for that particular stage of development.
The importance of clear and concise messaging
A data package for a CSR (composed of summary tables, by-patient listings, and figures) can be well over 5,000 pages. How does a medical writer distill that massive amount of data into a clear and concise message? It starts with the key messages the team plans to present in the drug’s label. Each endpoint of the pivotal studies should be mapped back to what is ultimately to be presented in the prescribing information (i.e., the label). With that key message map as a guide, the medical writer can start to distill the volumes of data that support each endpoint. Crafting a concise summary that conveys the key messages to the reviewer is something experienced medical writers do for every document.
Consistency is key!
It’s very rare that only one medical writer contributes to a submission. Frequently, multiple writers contribute different pieces of the documents, and efficacy and safety teams are often formed in order to concentrate on those particular topics more fully. Regardless of how many writers and reviewers are contributing, it’s critical that the submission is composed of “one voice.” All key messages should be presented in the same way as that message percolates up through the CSRs, to the integrated summaries of efficacy and safety, to the Module 2 summaries, and finally to the Clinical Overview. An experienced project manager should be driving the approval of those key messages at the start of the submission and review each document to ensure that “one voice” has presented the key messages consistently. Likewise, writers use tools like templates and style guides to ensure uniformity across the multiple documents that make up a submission.
Make your reviewer’s job easier
The use of templates for regulatory documents is not only a great way to ensure uniformity across documents, but that uniformity in appearance makes your reviewer’s job easier, too. With multiple CSRs contributing to the submission, a reviewer will rely on an experienced medical writer to build these documents using a solid framework. Study design and statistical sections should always be in the same location in each CSR. Sections presenting study results should have text and tables that have a uniform appearance with similar heading structures to allow for cross reviews. Those heading structures should eventually form a comprehensive navigation structure that a reviewer will use when moving through a document electronically. Finally, a good medical writer understands the “two click” rule that ensures a reviewer never has to click through more than 2 links to get to critical information.
Our last piece of advice is simple: put yourself in your reviewer’s shoes during your final read-through. Does the document convey important messages and are those messages easy to find? Can I get from one part of the document to the next using internal navigation tools? Are the key messages repeated in a consistent manner and does it read as if there is only “one voice”?
Nancy Gasper Smith, PhD, RAC, SVP
Medical Writing Services
Nancy Gasper Smith, PhD, RAC, is the Senior Vice President of Medical Writing Services and has over 14 years of regulatory medical writing experience. Nancy is a member of the Syner-G Executive Leadership Team, and her group of experienced medical writers and quality control (QC) specialists provide support for a variety of regulatory documents across a wide range of therapeutic areas and all phases of development (including clinical study reports, protocols, investigational brochures, safety narratives, and high-level documents such as integrated summaries of safety and efficacy, Module 2 clinical summaries and overviews, and FDA and Advisory Committee briefing documents).
Nancy’s experience includes project management and medical writing for multiple marketing applications (NDAs/BLAs/MAAs). She and her team provide a unique approach to regulatory medical writing and project management, as each document, project, or submission comes with its own challenges. In particular, the Medical Writing Services group at Syner-G has a wealth of expertise collaborating with clients to emphasize the importance of consistent and accurate messaging across submission documents.
Prior to joining Syner-G, Nancy served as the Vice President of Medical Writing Services at Impact Pharmaceutical Services for over 12 years (at which time Impact was acquired by Syner-G in late 2021). Nancy received her PhD in Biomedical Science and Biotechnology from The University of North Carolina at Charlotte and was a Postdoctoral Research Associate at the Duke Human Vaccine Institute within the Duke University Medical Center.