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.
With an increasing degree of early phase clinical research driven by smaller pharmaceutical and biotech companies, there is a drive toward moving fast (while NOT breaking things) that requires project teams, including medical writers, to achieve deliverables on ever shortening timelines. However, in the regulated clinical research space, a high degree of quality needs to be maintained given potential negative outcomes of poor quality when it comes to the conduct of a study, treatment of patients with investigational product, and interactions with regulatory authorities.
While technology (including AI) can be utilized to improve productivity, such tools may not always be available or cost-effective within a company or department. However, at least as of today, actions that will have significant impact on timelines can be implemented at a team and individual level without new tools being required, and much of it boils down to effective communication and knowledge sharing. Some examples are provided below.
A well-integrated team is a core element of generating a quality document in a timely manner, but how do we build such a team, especially when its members are usually spread across multiple companies and time zones? A kickoff meeting is often a requirement, but it is also an opportunity to put faces to names, clarify expectations and roles, and starting building a sense of shared goals. Ongoing communication, both ad hoc and with regular meetings (not too often), ensures that there are frequent opportunities to share risks and solve problems as a team. This environment of open communication between team members makes it more likely that problems are identified and addressed early which in turn prevents delays and quality issues.
Based on the roundtable on protocol QC, an increasingly common challenge is the need for in‑depth QCs of complex protocols with shorter and shorter turnaround times. To achieve this, both the lead writer and the QCer play a part. For the medical writer, they should make it as easy as possible for the QCer to find the supporting materials they need to compare against the primary document. This can be through detailed annotation and a meeting with the QC if the complexity of review warrants it. For the QCer’s part, it is important that significant findings or patterns of issues be communicated early to the medical writer to allow time to research or, in case of a misunderstanding, forestall unnecessary review findings.
Human considerations are paramount even when considering implementation of AI tools. While AI tools are “new and shiny” and offer promising benefits, teams of people will be the ones using it, and as with most projects, the right tool is significantly better at getting the job done than a tool that is just good enough. There needs to be team input from the beginning on their needs and what would be helpful for the work they do; once a suitable tool is selected, the team input should continue with a process by which early users can provide feedback, tips, and guidance on how best it can be utilized. These lessons can then be shared with all users to make the roll-out that much smoother with less wasted time and effort.
As clinical research continues to evolve with new tools, innovative study designs, and a changing regulatory landscape, what remains constant is that a strong team with good communication will be better able to manage these changes and the time pressures that come with them. My experience with the PROMETRIKA team is that we value building teams, both within our company (and across departments) and with our sponsors and other partners, and this has been a cornerstone in how we provide quality service.
