All Times EDT
Keywords: Historical trial data, HTD, innovative designs, regulatory guidance, COVID-19
The utilization of historical trial data (HTD) in clinical trials offers innovative opportunities to accelerate the development of life saving treatments and delivery to patients in need. This is accomplished by developing efficient study designs and through effective data exploration and interpretation.
Attendees to this Roundtable will increase their understanding of existing HTD regulatory guidance related to historical trial data, as well as discuss suggestions to expand the applicability of such methods. In particular, attendees will discuss the differences between HTD and real-world data/evidence (RWD/RWE) with respect to data quality, availability, and regulatory acceptance. Attendees will also learn from and discuss real examples and use cases as shared by one another and as explored through TransCelerate’s Historical Trial Data Sharing Initiative. Attendees will have the opportunity to learn about existing repositories of high-quality HTD, such as the DataCelerate database, and various approaches the TransCelerate Historical Trial Data Sharing Initiative workstreams have taken to ensure better data through collaboration with regulatory bodies and industry subject matter experts. Finally, attendees will discuss potential uses of historical trial data sharing in COVID-19 trials.