Since early this year, many standard clinical trial processes have been significantly disrupted. Patients have been prevented from attending regular physician visits. Clinical research associates who traveled regularly to study sites to review and verify processes and data were unable to do so. Supply chain upheaval has forced schedule modifications and substitutions for products in short supply. Committees and boards accustomed to meeting in person were relegated to virtual gatherings, and clinical trial logistics had to be re-evaluated for time, cost, and quality expectations.
In these excerpts from their recent presentation, Premier Research’s Stacy Weil, Senior Vice President, Clinical Data Operations, Strategic Business Optimization, and Nach Dave, RPh., MSc, Vice President, Development Strategy, discuss the need to change the way patients participate in trials and how we collect and monitor data.