Master Protocols and Complex Innovative Design

The digital revolution has transformed many areas of our life including pharmaceutical drug development to enhance efficiency and optimize value in clinical trials. The session is meant to draw more attention in the face of the coronavirus disease 2019 (COVID-19) outbreak, which has caused unprecedented disruption in the conduct of clinical trials and presented considerable challenges and opportunities for clinical trialists and data analysts. Speakers will present opportunities with virtual, remote, digital, or decentralized clinical trials as viable options to enhance efficiency in drug development and, more importantly, in offering diverse patients easier and attractive means to participate in clinical trials. Case studies will be shared to highlight benefit and challenges in using digital data and telemedicine to clinical trials including data acquisition, processing, and analysis in a virtual trial setting. Issues of patient safety, measurement validity, and data integrity will be reviewed, and considerations are put forth with reference to the mitigation of underlying regulatory and operational barriers.