After record attendance and a high energy atmosphere at SCOPE 2020 in Orlando last week, the ArcheMedX team wanted to share our key takeaways:
- With an entire track dedicated to Quality & Monitoring it is clear that whether you are focused on your broader risk-based quality management strategy or still zoomed in on risk based monitoring, data visualization is key to identifying the insights that support decisions to mitigate risk. It was also evident that we are still chasing lagging indicators of risk and our models will benefit from identifying earlier leading indicators of potential issues.
- Jennifer Ross solidly guided us through a discussion of basket, umbrella, and platform protocol designs and the necessary randomization methodologies. These different designs and their growing utilization continues to increase the complexity of the clinical trial landscape and reminds us of the essential nature of preparing project teams and site staff to execute on these designs.
- Easing the burdens of participation for sites and patients was a theme that crossed multiple tracks. Whether it was partnering with advocacy groups, exploring the benefits of active listening, developing novel ways to collect protocol design feedback from sites and direct from patients, or demonstrating the continued technological improvements across our industry, removing obstacles and minimizing the burden for patients and sites to participate garnered much warranted attention.
- It was refreshing to hear multiple speakers debunk the hype around the potential for AI and ML to transform clinical research and instead focused on more practical use cases. These presentations and the hallway conversations that ensued explored how sponsors and CROs are currently applying data analytics (and some meaty algorithms) to inform research teams today on how they can optimize study design, protocol feasibility, site selection, and risk based monitoring.