On-Demand Webinar: In the midst of the COVID-19 global pandemic, the biopharma/biotech industry has engaged in the rapid development of diagnostic tests, treatments, and vaccines for novel coronavirus. Because this is a new pathogen with substantial morbidity and mortality, programs including treatment trials are moving forward quickly, although data on viral shedding, seroprevalence, and transmissibility are still accumulating. Clinical development and medical affairs scientists as well as operational specialists engaged in clinical research must balance the lack of information and uncertainty with the urgent need to be agile, pragmatic, and creative in the design and implementation of real-world pandemic studies. In this webinar, we will share design considerations and challenges for a real-world data (RWD) external control arm for a COVID-19 treatment. We will discuss core scientific considerations for the development of an external control arm to rapidly collect standard of care (SOC) data in treatment trials lacking randomization to an SOC comparator. Additionally, we will discuss the operational strategies to rapidly deliver RWD on SOC during a global pandemic.
Discussion Points
This webinar will discuss:
Foundational scientific principles inherent in rapidly assembling and analyzing data from a robust real-world external control arm in the midst of a pandemic, including:
- Sampling frame
- Nature and scope of the variables needed for effective matching
- Case Report Form design
- Control of confounding
- Appropriate outcomes
Operational strategies and flexibility needed to rapidly deliver data for RWD external control arms during an active pandemic, including:
- Site selection strategy
- Feasibility and speed of data acquisition
- Presence of key variables
- Pandemic influences
Key Learning Objectives
By the end of this webinar, participants should understand:
- Key challenges/considerations (both scientific and operational) inherent in assembling and analyzing data from a robust RWD external control arm in the midst of a pandemic
- Concepts of a concurrent (or historical) external comparator arm
- Principles of ensuring comparability of the external control group to patients enrolled in active treatment trials
- Sources of RWD used to assemble an external comparator
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