THOUGHT LEADERSHIP

As a Senior Medical Writer, I participated in the 2024 annual conference of the American Medical Writers Association (AMWA) to lead a roundtable on protocol QC and keep up to date on trends and best practices in documents related to clinical research. While many of the best attended sessions were related to the current and upcoming use of AI in the field of medical writing, there were plenty of sessions and workshops (as well as discussions during the protocol QC roundtable) that served as reminders that it is still the human aspect of projects that make the greatest impact in the timeliness and quality of a document or project.

On the surface, a medical writer has a simple calling: communicate medical information and research results clearly to the intended audience. How one achieves this goal is what sets apart a great medical writer. Arriving at a high-quality final document requires planning, clear communication, coordination between team members, and building consensus among stakeholders. These are not directly related to writing per se but are central to the success of our projects, so how does a medical writer learn and hone such skills?

Over the past 15 – 20 years, projected peak sales and return on investment (ROI) of new drugs has been shrinking (source: Statista and Deloitte Centre for Health Solutions). To offset this, pharmaceutical companies are pushing to get more drugs to market and multiple indications for each agent.

Decentralized clinical trials (DCT) seems to have burst on to the scene in just the last few years, so it is easy to get swept up into how we can best implement them into our clinical trials. However, it is worth examining the past of this supposedly “new” method of conducting clinical trials.

“PROMETRIKA invites you to read and enjoy a two-part blog series on risk-based monitoring (RBM) and the different clinical trial monitoring approaches based on our clinical operations team’s experience and research objectives.  We will explore the differences between the traditional 100% source document verification (SDV) approach and RBM through the lens of two hypothetical clinical research associates (CRAs) as told in the style of an afternoon soap opera.”