Sponsor Accrual of Investigative Add-On Sites

Date

2016-05-01

Authors

Arbov, Eli

ORCID

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Abstract

Meeting enrollment goals in clinical research trials has become increasingly more difficult due to heightened regulations and more stringent study protocols. This practicum report explores some of the reasons why sponsors in clinical research trials occasionally need to enlist the aid of investigative add-on sites, and highlights some of the unique opportunities that are presented to prospective add-on sites. Advanced Care Research Centers (ACRC) Trial’s current involvement in a contraceptive study, as an investigative add-on site, provides this report with a case study, where observations and the analysis of enrollment data can appraise their success as an add-on site. Past trials are also assessed in order to supplement other themes raised in this discussion.

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