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eTRIALS. OPPORTUNITIES AND CHALLENGES

Chairpersons : Rob Califf (Durham, USA), Bram Zuckerman (FDA, USA)
8.00 am – 1.00 pm
 This session aims at discussing the current state of the use of digital technology
and mobile health in clinical trials in cardiovascular medicine, what data is
available for utilizing digital technology as a supportive tool or an intervention in
clinical trials, and how can digital technology be used to streamline clinical trial
conduct (reduce visits, enrollment/recruitment, subject retention, safety data
collection, “site-less” remote clinical trials).
 Potential outcomes (ex. PRO, HR/BP, and activity trackers) can be used with
digital health. Can these be used for new drug registration trials and/or postmarketing
trials?
 Experts in large IT data platforms will present case studies and discuss what can
be gained in CV clinical trial conduct and what are the barriers/challenges to
utilizing digital technology in global CV clinical trials.
Keynote lecture
Integrating Data Science with Evidence Generation
Rob Califf (Former commissioner, FDA, People centered Research Foundation,
Verily, Durham, USA)
Opportunities and challenges with medical informatics use for clinical trials?
Adrian Hernandez (Durham, USA)
IBM Watson Health
Irene Dankwa-Mullan (IBM, USA)
Health eHeart Study and Health eHeart Alliance
Carol Maguire (San Francisco, USA)
Approach to Virtual Trials (eConsent to ePROs)
Anthony Costello (Medidata, USA)
The National Patient Centered Clinical Research Network (PCORnet)
Adrian Hernandez (Durham, USA)
Issues in the acquisition, analysis, and sharing of data in the field of
cardiovascular science
Elliot Antman (Boston, USA)

How to move from hospital visit and patient reported outcomes to real-life
objective measurements
Pierre-Yves Frouin (Bioserenity, FRA)
Utility of geofencing to capture missing hospitalizations in clinical trials.
Abhinav Sharma (Stanford, USA and Nancy, FRA)
Methodology/statistical viewpoint
Nancy Geller (NHLBI, USA)
Investigator viewpoint
Mintu Turakhia (Stanford, USA)
Industry viewpoint
Helina Kassahun (Amgen, USA), Kenneth Stein (Boston Scientific, USA), Nancy Dreyer
(Quintiles, USA)
Patient's Perspective for Clinical E-Trials
Debbe McCall (Murrieta, USA)
Regulatory viewpoint
Bakul Patel (FDA, USA), Gail Pearson (NHLBI, USA), Krishna Prasad (EMA, GBR),
Bram Zuckerman (FDA, USA)
The Forum. Moderated discussion with the audience
Chairpersons : Rob Califf (Durham, USA) , Bram Zuckerman (FDA, USA)
Panelists: Elliot Antman (Boston, USA), Rob Califf (Durham, USA), Anthony Costello
(Medidata, USA), Debbe McCall (Murrieta, USA), Irene Dankwa-Mullan (IBM, USA),
Nancy Dreyer (Quintiles, USA), Pierre-Yves Frouin (Bioserenity, FRA), Nancy Geller
(NHLBI, USA), Adrian Hernandez (Durham, USA), Stefan James (Uppsala, SWE),
Helina Kassahun (Amgen, USA), Carol Maguire (San Francisco, USA), Bakul Patel
(FDA, USA), Gail Pearson (NHLBI, USA), Krishna Prasad (EMA, GBR), Mintu Turakhia
(Stanford, USA), Kenneth Stein (Boston Scientific, USA), Bram Zuckerman (FDA, USA)