Last week I attended the excellent RQA International Conference titled “Quality that Works: Pragmatism Over Perfection.” It’s a theme that resonates with those of us in GCP QA, forced as we are by the speed and complexity of clinical trials to be ruthlessly pragmatic. It also dovetails with a current preoccupation of mine: Why do we do what we do in GCP QA? Could we be doing it better?
I trace back this crisis of faith to a moment several years ago when I was working with a study team on the root cause analysis of a deviation that occurred during study start-up. They just weren’t getting the concept of root cause. They claimed that the root cause of the issue was that a CRA had made a mistake, and the corrective action was that they had fired the CRA. I patiently (at first, anyway) explained that we needed to identify the underlying, systemic cause of the issue so we could prevent it from happening again. “But study start-up is over,” one of the team members told me. “It’s not going to happen again.”
Before I could open my mouth to remind the team that they would be starting up other studies, I took a breath to consider it from their perspective. This was a long oncology study with a small biotech. By the time the team started up the next study in the program, the entire team and, likely, all the vendors would have turned over. The study was complex, and there were lots of other issues competing for the team’s attention. If I weren’t in QA, I wouldn’t want to spend time on this root cause analysis, either.
This led me down a rabbit hole of questioning everything we do in GCP QA. Why do our SOPs need to have a Responsibilities section? Why do we manage some quality issues in QA, but not protocol deviations? What is the value in conducting qualification audits? My questions at first focused on rationale – what value does this add? – but progressed to history – how did this start? What are the historical foundations of this practice?
In this series of blog posts, we’ll trace back the history of Quality Assurance through the history of Quality to try to figure out how we got here. Next, we’ll examine GCP QA practices against our customers’ needs. Finally, we’ll consider how we might do things differently.
(The photo is Alice Roosevelt Longworth, daughter of US President Theodore Roosevelt, who allegedly kept a throw pillow on her sofa that said, "If you don't have anything nice to say, come sit by me.")
