Authors:Alecia Clary , Ph.D., MSW (AC) (Corresponding author)Affiliation: The Reagan-Udall Foundation for the FDA, Washington, DC, USA Address: 1333 New Hampshire Ave, NW Suite 420, Washington DC 20036, USA Email: aclary@reaganudall.org Phone: 202-849-2075 ORCID ID: 0000-0002-7774-9808Nancy D Lin , (NDL) Affiliation: IQVIA Real World Solutions, Bridgewater, NJ, USA Address: 77 Corporate Drive, Bridgewater, NJ 08807 Email: Nancy.lin@iqvia.comTamar Lasky , (TL) Affiliation: The United States Food and Drug Administration, Office of Data, Analytics, & Research, Office of the Commissioner, Washington DC, USA Address: 10903 New Hampshire Avenue, Silver Spring, MD, USA. Email: Tamar.lasky@fda.hhs.govMatthew W Reynolds , (MR) Affiliation: IQVIA Real-World Solutions, Washington, DC, USA Address: 201 Broadway, Cambridge, MA, USA. Email: Matthew.Reynolds@IQVIA.comAnand Chokkalingam , (ACH) Affiliation: Gilead Sciences, Foster City, California, USA Address: 333 Lakeside Drive Email: Anand.Chokkalingam@gilead.comCarla Rodriguez-Watson, (CRW)Affiliation: The Reagan-Udall Foundation for the FDA, Washington, DC, USA Address: 1333 New Hampshire Ave, NW Suite 420, Washington DC 20036, USA Email: crodriguezwatson@reaganudall.orgThis paper has not been previously printed, currently has not been submitted for publication in any other journal and is not pending acceptance in any other journal. We have not had any prior correspondence with the journal about the manuscript.