Description
Real-world evidence is increasingly of interest in developing clinical guidelines, regulatory reporting and in clinical trials. We present our implementation and evaluation of real-time adverse event reporting through patient-reported outcomes in the ongoing I-SPY2 platform trial for early breast cancer.
Learning Objective: Challenges in implementing an ePRO in a Phase II clinical trial
Provide workflows on improving completion rates at the point of care
Understanding of interoperability challenges of sending ePROs from clinical trials back to EHRs
Authors:
Adam Asare (Presenter)
UCSF
Smita Asare, Quantum Leap Healthcare Collaborative
Amrita Basu, UCSF
Sue Dubman, Quantum Leap Healthcare Collaborative
Mitra Rocca, US Food and Drug Administration
Aheli Chattopadhyay, UCSF
Jessica Hong, Quantum Leap Healthcare Collaborative
Lisa Weiss, Quantum Leap Healthcare Collaborative
Ruby Singhrao, UCSF
Amy Wilson, Quantum Leap Healthcare Collaborative
Garry Peterson, UCSF
Devon McCabe, Quantum Leap Healthcare Collaborative
Jeff Matthews, Quantum Leap Healthcare Collaborative
Cal Collins, OpenClinica
Karyn DiGiorgio, Quantum Leap Healthcare Collaborative
Bev Parker, I-SPY Advocacy Group
Susie Brain, I-SPY Advocacy Group
Diane Heditsian, I-SPY Advocacy Group
Laura Esserman, UCSF
Michelle Melisko, UCSF
Presentation Materials: