In clinical research, precision, clarity, and adherence to regulatory guidelines are non-negotiable. So, what does a medical writer do in this space?

These experts play a crucial role in shaping trial documents, interpreting and representing trial outcomes, and providing consistent communication to stakeholders. To dive deeper into the essential role of a medical writer, we spoke with Janet Hillary from Southern Star Research to explore the intricacies of the job, its challenges, and how medical writers collaborate across the teams to drive successful trials.

Q: How did you become a medical writer and start working at Southern Star Research?

Janet: I hold degrees in chemistry and biochemistry, a PhD in pathogenic microbiology, and a BA in communications. My journey began in academic research before moving into clinical research as a Clinical Research Associate (CRA). I've been with Southern Star Research for five years now, and my diverse background has perfectly prepared me for the world of medical writing.

Q: What does a medical writer do in a typical week?

Janet: Each week starts with reviewing each project’s status and priorities, ensuring timelines are on track. I collaborate with colleagues and attend meetings, which are crucial to progressing each document. Most of the week is dedicated to writing, whether drafting protocols, Investigator’s Brochures (IBs), or Clinical Study Reports (CSRs). It requires focused time at the computer, researching, reading, and synthesizing information.

Q: How does a medical writer collaborate with stakeholders during a trial?

Janet: We mostly communicate with clients through project managers (PMs), who send any queries we have to the sponsor while we work on the draft document. However, when getting close to delivery, we will also communicate directly with the sponsor via email or in meetings.

Internally, we collaborate with the medical monitor, lead statistician, data management, and clinical operations teams to ensure accuracy and coherence in the trial documents. We aim to create practical, easy-to-understand documents for study sites and data management teams. Clarity and consistency are crucial throughout the document, from the synopsis to the detailed schedules and assessments. We work hard to avoid discrepancies and ensure the information is clear and aligned with trial objectives.

Q: Which is the most challenging clinical trial-related document for you to write?

Janet: I can't really pick just one! Each of the big three (protocol/CIP, IB, CSR/CIR) are all challenging in their own way and require different approaches.

Q: What information is needed for you to start writing a protocol?

Janet: The sponsor will usually provide at least a synopsis or draft protocol document as a basis, and we will start preparing the full document using our own tried and tested template (usually). The synopsis may contain an outline of the study design, objectives/endpoints, eligibility criteria, and a schedule of assessments, although the SSR team can also assist with fleshing all of these out where required. 

It is also very useful to understand the context in which the IP is being tested and the regulatory aims of the study. Any correspondence with regulatory agencies and/or regulatory advice is beneficial to ensure we are on the right track with study design, objectives/endpoints, and to provide references to applicable regulatory guidelines. 

Q: What do you need from the sponsor to write an Investigators’ Brochure?

Janet: We need immediate access to all nonclinical study reports and any clinical study reports associated with the study product, characterisation of the study product documents, and relevant reference lists. It is also helpful to understand the regulatory landscape for the document, including any correspondence with regulatory agencies for the investigational product. 

Q: What information do you need to finalize the Clinical Study Report?

Janet: We need finalised TFLs, study documents (e.g., all protocol versions, CRF, study information) and all associated CSR documents to be finalised (e.g., PK report). For a CSR to be finalized we need to prepare the appendices as per ICH E3.

The client or sponsor will need to review drafts, plus approve finalization. Then, the CSR is often reviewed, approved and signed by the Principal or Coordinating Investigator, depending on regulatory requirements and Sponsor preference. 

Southern Star Research's medical writing team is committed to producing high-quality trial documents that meet regulatory and scientific standards. Our expertise helps clinical trials progress smoothly and equips sponsors with the tools for successful drug development.

Medical writers may work behind the scenes, but their contributions are pivotal in ensuring clinical research is communicated clearly, accurately, and effectively. Their role continues to be essential in advancing medical science and improving patient outcomes.

If you want to learn more about working with an Australian clinical research team that is professional, dedicated, and committed to safe and scientifically sound studies, get in touch with us today.

Southern Star Research is a full-service Australian Contract Research Organization. We help sponsors run safe and efficient trials that meet regulatory requirements, ensure scientific excellence, and demonstrate the commercial viability of your product. If you're looking for an agile and dedicated team to help you run a successful trial, contact us today.