Development of clinical research process metrics and tracking improvement in quality assurance in clinical trials.

Abstract

e16572 Background: Quality assurance (QA), efficient timelines, improving risk management and cost effectiveness are critical to the clinical trials (CT) in academic centers in the current economic climate. Site selection is highly competitive and many academic centers are seeking innovative methods for attracting and managing CT effectively. The number and enrollment in cancer CT has been declining in North America since 2008, while global metrics are on the rise. In 2010, Princess Margaret Hospital reviewed their CT processes, developed a process improvement plan (PIP), and a QA program. Methods: PIP: Value Stream Mapping of the study start-up process (SSUP) and time to first patient fist visit (FPFV) was performed for CT activated in 2008/09. Time between SSUP submissions (Institutional Review Board (IRB), Grants and Contracts (G+C) and Impact Assessment (IA)) was analyzed. Times were described in days (d) using the median (MED) and inter-quartile range (IQR). Report Cards depicting SSUP and FPFV were issued to Principal Investigators (PI). Structured interviews were conducted to determine what enabled/hindered efficient SSUP and FPFV; differences in MED times were compared using non-parametric tests. QA: A review of CT quality parameters was conducted (16 studies/104 subjects) using a standardized review process. Internal QA reports and external audit reports were trended. Results: PIP: n=107. We looked at efficiency of SSUP based factors including CT staff experience, the sequence in submissions and PI involvement. QA: The top QA deficiencies were: informed consent process (46%), delegation of duties (44%), delayed AdEERS reporting (33%) and discrepancy in Recist response (31%). Training, tracked by QA metrics, significantly improved AdEERS reporting times (p=0.01). Conclusions: Findings have driven standard operating procedures and training initiatives. SSUP, FPFV and QA data are reported annually to ensure continuous improvement. Ongoing assessment and tracking of metrics are essential to maintaining high quality, accountability and efficiency for North American academic centers. Process MED (d) IQR (d) IRB 93 52-145 G+C 95 30-151 IA 36 20-78 SSUP 136 86-202 FPFV 54 15-121