Redefining feasibility in clinical trials: Collaborative approaches for improved site selection.

Beau Bruneau¹, Kristin Surdam², Amy Bland³, Amy Krueger⁴, Andrew Wise⁵, Ani Cotarlan⁶, Asher Leviton⁶, Elena Jouravleva⁷, Grace Fitzgerald⁸, Heather N Frost⁹, Honora F Cutler¹⁰, Joshua Buddle¹¹, Luis G Diaz¹², Michele Cohen^6,6, Nancy A Sacco¹³, Ryan Washington¹⁴, Susan Mauermann¹⁵, Victor Chen¹⁶, Andrea Bastek¹⁷

¹Florence Healthcare, USA.

²KOL & Strategy, Florence Healthcare, USA.

³Clinical Research, Baptist Health Little Rock, USA.

⁴Bon Secours Mercy Health, USA.

⁵Elevation GCP Consulting, LLC, USA.

⁶Icahn School of Medicine at Mount Sinai, USA.

⁷Corporate Quality and Education, Sarah Cannon Research Institute, USA.

⁸Site Enablement League, USA.

⁹Global Clinical Information Solutions, Information Management, Pfizer Research & Development, Pfizer, USA.

¹⁰Clinical Research Operations, Drexel University, USA.

¹¹Clinical Operations, Flatiron Health, USA.

¹²Regulatory, University of South Florida and Tampa General Hospital, USA.

¹³Clinical and Site Development Ops, SiteBridge Research, Inc, USA.

¹⁴Cancer Clinical Trials Office, SUNY Stony Brook Cancer Center, USA.

¹⁵Medical College of Wisconsin, USA.

¹⁶Clinical Trials Program, The Permanente Medical Group, USA.

¹⁷Innovations, Florence Healthcare, USA.

PubMed PMC DOI PDF

Abstract

BACKGROUND: This Site Feasibility Task Force convened to assess the complex and burdensome process of site feasibility in clinical trials. The objective was to create mutual understanding of challenges and provide suggestions for improving collaboration among sponsors, contract research organizations (CROs), and sites. METHODS: The task force was composed of representatives from sponsors, CROs an…

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