Setting a Real-World Strategy in an Evolving Clinical Research Environment

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. We need to change the way patients participate in trials and how we collect and monitor data. Adopting processes that are more flexible and agile while maintaining data integrity and quality has emerged as a primary focus for everyone involved in conducting clinical trials. This webinar will focus on these process steps: • Quality data capture. What types of technology can be used to evolve processes that require a renewed focus on remote data capture? Where will the data come from and where will it live? • Data access. Who will handle the data? How it will it be transmitted and processed? • Information review. Once data becomes information, how will it be reviewed? What initiatives are driving collaborative, data-driven decision-making? There is growing consensus that researchers and regulators must adopt a holistic product development approach versus the limited approach of years past. Developers will need to build development plans that include traditional clinical trials and then some. Areas that will complement the traditional randomized clinical trial data will include use of real-world data and evidence to support future clinical trial submissions, building economic strategies in support of product development, and understanding how traditional and non-traditional data points will contribute to an overall data strategy for a product or a portfolio of products.