Process Innovation Improves Trial Operation Efficiency.
Background: Despite the fact that unaddressed delays in clinical trial operation could severely compromise the overall effort invested, there seems to be a lack of concerted effort in reforming such delays. This study evaluated the composite effect of initiatives in reforming trial operation efficie...
| Published in: | Therapeutic Innovation & Regulatory Science Vol. 50; no. 4; pp. 510 - 515 |
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| Main Authors: | , , , , , , , , , , , |
| Format: | research tables/charts Journal Article |
| Published: |
Springer Nature
Jul2016
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=116426792&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 116426792 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 21684790 FUHO jtl: Therapeutic Innovation & Regulatory Science issn: 21684790 maglogo: N pubinfo: dt: Jul2016 vid: 50 iid: 4 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 116426792 116426792 116426792 10.1177/2168479016634148 116426792 ppf: 510 ppct: 5 formats: tig: atl: Process Innovation Improves Trial Operation Efficiency. aug: au: Choi, Yun Jung Kim, Kyu-pyo Park, Sumi Park, MiYeon Kim, Sulhwa Kim, Younkyoung Bae, Kyun-Seop Beck, Sung-Ho Choi, Ki-Eun Chung, Jong Woo Lim, Young–Suk Kim, Tae Won affil: Asan Medical Center, Clinical Trial Center, Seoul, Korea sug: subj: Program Implementation Clinical Trials Time Factors Productivity Funding Source Academic Medical Centers South Korea Institutional Review Retrospective Design Chi Square Test Fisher's Exact Test Data Analysis Software Descriptive Statistics Pretest-Posttest Design Mann-Whitney U Test ab: Background: Despite the fact that unaddressed delays in clinical trial operation could severely compromise the overall effort invested, there seems to be a lack of concerted effort in reforming such delays. This study evaluated the composite effect of initiatives in reforming trial operation efficiency. Methods: A high-volume academic medical center in Korea has implemented various initiatives to improve the trial operation efficiency by expediting times from institutional review board (IRB) submission to approval, from IRB submission to trial open for subject enrollment, and from trial open to first patient-in. The initiatives include implementation of the protocol preliminary review, parallel processing of the clinical trial agreement review in line with the protocol submission to the IRB, and involvement of project manager for operational risk management. Times from IRB submission to approval, from IRB submission to trial open, and from trial open to first patient-in before and after implementation of initiatives were compared. Results: The median time required in IRB approval was meaningfully shorter in the postinitiative group (19 vs 14 days; P < .001). The median times from IRB submission to trial open for subject enrollment and from trial open to first patient-in were reduced significantly in the postinitiative group (trial open: 25 vs 18 days, P < .001; first patient-in: 111.5 vs 100 days, P = .014). Conclusions: The initiatives were effective in reforming trial operational efficiency. Additional studies to address the cause of operational delay and modifiable factors influencing subject enrollment are needed to further improve operational efficiency. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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