Dr Mats Sundgren, a founding member of our Institute, gave a presentation at SCOPE 2020 earlier this month on a new Pragmatic Clinical Trial (PCT) launched by AstraZeneca. In this PCT, they use real world registry data to establish the efficacy and safety of an existing drug for a new clinical indication.
This is the first-of-its-kind, indication-seeking PCT in the industry. It demonstrates an important use of routinely collected health data to generate evidence to the quality demanded by medicines regulators to extend the license of a drug to a new clinical indication.
The DAPA-MI trial that was presented, is a pioneering Registry-based Randomized Controlled Trial (R-RCT) and combines “gold standard” RCT elements with innovative, real-world trial elements.
Its unique trial design could ultimately lead to a higher recruitment rate and lower overall costs in comparison to conventional clinical trials. R-RCTs are more efficient clinical trials – allowing for immediate access to data, lower per patient cost and streamlined delivery – enabled by fewer trial visits and patient-centric digital solutions.