The mission of Ethics and Real-World Evidence Research Project is to research and advance policy approaches for the generation and interpretation of real-world evidence and data. As a project of NYU Langone’s Division of Medical Ethics Working Group on Compassionate Use and Preapproval Access, we center ethical concerns, patient welfare, and societal issues at the core of our work.

Our goals are to identify best practices for the ethical usage of real-world evidence by industry, regulatory bodies, and payers, with a specific focus on data from non-trial preapproval access to investigational interventions. Our members are experts in bioethics, biostatistics, industry, patient advocacy, and big data.

Our Team

Alison Bateman-House, PhD, MPH
Co-chair
alison.bateman-house@nyulangone.org

Hayley Belli, PhD
Co-chair
hayley.belli@nyulangone.org

Alen Agaronov, ScD
alen.agaronov@nyulangone.org

Arthur L. Caplan, PhD
arthur.caplan@nyulangone.org

Sanket Dhruva, MD
sanket.dhruva@ucsf.edu

Holly Fernandez Lynch, JD, MBE
lynchhf@pennmedicine.upenn.edu

Cláudia Hirawat
chirawat@vozadvisors.com

Andrew McFadyen, BA, BEd
mcfadyena@me.com

Jennifer Miller, PhD
jennifer.e.miller@yale.edu

Tobias Polak, BSc, MSc
t.polak@erasmusmc.nl

Barbara Redman, PhD, MBE, RN
bkredman@comcast.net

Tom Watson, BS
tom.watson@bionicalemas.com

Learn more about our team and other members of NYU Langone’s Division of Medical Ethics Working Group on Compassionate Use and Preapproval Access.

For questions about the Ethics and Real-World Evidence Research Project, please contact John Massarelli, program coordinator of the Working Group on Compassionate Use and Preapproval Access, at john.massarelli@nyulangone.org.