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. 2021 May 4:22:100774.
doi: 10.1016/j.conctc.2021.100774. eCollection 2021 Jun.

Non-cancer clinical trials start-up metrics at an academic medical center: Implications for advancing research

Colin Cernik  1 , Elena Shergina  1 , Jeffrey Thompson  1 , Karen Blackwell  2 , Kyle Stephens  2 , Kim S Kimminau  3 , Jo Wick  1 , Matthew S Mayo  1 , Byron Gajewski  1 , Jianghua He  1 , Dinesh Pal Mudaranthakam  1
Affiliations

Non-cancer clinical trials start-up metrics at an academic medical center: Implications for advancing research

Colin Cernik et al. Contemp Clin Trials Commun. .

Abstract

The primary goal for any clinical trial after it receives a funding notification is to receive regulatory approval and initiate the trial for recruitment. Every trial must go through documentation and regulatory process before it can start recruiting participants and collecting data; this initial process of review and approval is known as the study start-up process (SSU). We evaluated the average time taken for studies to receive approvals. Using data from clinical trials conducted at the University of Kansas Medical Center, various times to reach the start of the study were calculated based on the dates of individual study. The results of this analysis showed that chart review studies and investigator-initiated trials had a shorter time to activation than other types of studies. Additionally, single-center studies had a shorter activation time than multi-center studies. The analysis also demonstrated that the overall processing time consistently had been reduced over time.

Keywords: Clinical trial activation; Institutional review board review.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
SSU stages.
Fig. 2
Fig. 2
Upset plot of the various types of studies and scopes.
Fig. 3
Fig. 3
SSU across study type and scope.
Fig. 4
Fig. 4
SSU across starting the year.
See this image and copyright information in PMC

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