A Trial Activation Initiative to Accelerate Trial Opening in an Academic Medical Center

作者：Choi Yun Jung; Jeon HyeJung; Kim Sinae; In YunJeong; Park Soo Yeon; Park MiYeon; Park Sumi; Lee YooMi; Kim Sulhwa; Kim Kyu pyo; Koo Ha Yeong; Kim Tae Won^*

来源：Therapeutic Innovation & Regulatory Science, 2015, 49(2): 234-238.

DOI：10.1177/2168479014554399

• clinical trial agreement
• contract
• parallel submissions
• study start up
• cycle time

Delays in trial opening should be considered critical for the sake of not only the sponsor but the patients, as they may result in inequities of care. The Asan Medical Center, in Seoul, Korea, implemented a trial activation initiative in July 2012, in an aim to expedite the trial initiation timeline. Time intervals between trial initiation steps and the rate of institutional review board (IRB) and clinical trial agreement (CTA) parallel submission were assessed. A higher rate of parallel IRB and CTA submissions was observed after initiative implementation (25.5% vs 52.3%; P < .001). Initiative applications were shown to significantly accelerate the median trial opening time, from 114 to 81 days (P < .001). Strategic processing of parallel submissions greatly shortened the median time required for trial initiation from 117 to 61 days compared with sequential submissions (P < .001). A trial activation initiative including parallel IRB and CTA submissions is an effective tool for accelerating trial commencements.

• 出版日期2015-3