Benchmarking Site Activation and Patient Enrollment

Mary Jo Lamberti; Abigail Dirks; Nicholas Kikuchi; Neha Patel Cervantes; Kenneth Getz

doi:10.1007/s43441-024-00638-1

Benchmarking Site Activation and Patient Enrollment

Ther Innov Regul Sci. 2024 Apr 3. doi: 10.1007/s43441-024-00638-1. Online ahead of print.

Authors

Mary Jo Lamberti¹, Abigail Dirks², Nicholas Kikuchi³, Neha Patel Cervantes⁴, Kenneth Getz²

Affiliations

¹ Tufts Center for the Study of Drug Development, Tufts University, 145 Harrison Avenue, Boston, MA, 02111, USA. mary_jo.lamberti@tufts.edu.
² Tufts Center for the Study of Drug Development, Tufts University, 145 Harrison Avenue, Boston, MA, 02111, USA.
³ Roche, Basel, Switzerland.
⁴ GSK, Philadelphia, PA, USA.

PMID: 38568347
DOI: 10.1007/s43441-024-00638-1

Abstract

Clinical trial conduct poses numerous challenges, many pertaining to patient recruitment. The primary objectives of this study were to update benchmarks on site activation and patient enrollment gathered in previous Tufts CSDD studies and examine current usage of recruitment and retention tactics. The data collection focused on site activation and patient enrollment metrics used for studies. Analyses were conducted comparing results from 2012, 2019 and 2023. The results indicate that actual enrollments exceeded planned enrollments for a majority of studies and timelines were shorter than expected. In addition, differences were found for enrollment achievement by global region and site type. Further investigation into studies conducted during a later time frame and post-pandemic could be compared with current benchmarks to examine differences.

Keywords: Patient enrollment; Recruitment and retention tactics; Site activation.