Junhao Liu1, Jo A Wick1, Dinesh Pal Mudaranthakam1, Yu Jiang2, Matthew S Mayo1, Byron J Gajewski1,3. 1. Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, KS, USA. 2. Division of Epidemiology, Biostatistics, and Environmental Health, School of Public Health, The University of Memphis, Memphis, TN, USA. 3. University of Kansas Cancer Center, Kansas City, KS, USA.
Abstract
BACKGROUND: Monitoring subject recruitment is key to the success of a clinical trial. Accordingly, researchers have developed accrual-monitoring tools to support the design and conduct of trials. At an institutional level, delays in identifying studies with high risk of accrual failure can lead to inefficient and costly trials with little chances of meeting study objectives. Comprehensive accrual monitoring is necessary to the success of the research enterprise. METHODS: This article describes the design and implementation of the University of Kansas Cancer Center Accrual Prediction Program, a web-based platform was developed to support comprehensive accrual monitoring and prediction for all active clinical trials. The Accrual Prediction Program provides information on accrual, including the predicted completion date, predicted number of accrued subjects during the pre-specified accrual period, and the probability of achieving accrual targets. It relies on a Bayesian accrual prediction model to combine protocol information with real-time trial enrollment data and disseminates results via web application. RESULTS: First released in 2016, the Accrual Prediction Program summarizes enrollment information for active studies categorized by various trial attributes. The web application supports real-time evidence-based decision making for strategic resource allocation and study management of over 120 ongoing clinical trials at the University of Kansas Cancer Center. CONCLUSION: The Accrual Prediction Program makes accessing comprehensive accrual information manageable at an institutional level. Cancer centers or even entire institutions can reproduce the Accrual Prediction Program to achieve real-time comprehensive monitoring and prediction of subject accrual to aid investigators and administrators in the design, conduct, and management of clinical trials.
BACKGROUND: Monitoring subject recruitment is key to the success of a clinical trial. Accordingly, researchers have developed accrual-monitoring tools to support the design and conduct of trials. At an institutional level, delays in identifying studies with high risk of accrual failure can lead to inefficient and costly trials with little chances of meeting study objectives. Comprehensive accrual monitoring is necessary to the success of the research enterprise. METHODS: This article describes the design and implementation of the University of Kansas Cancer Center Accrual Prediction Program, a web-based platform was developed to support comprehensive accrual monitoring and prediction for all active clinical trials. The Accrual Prediction Program provides information on accrual, including the predicted completion date, predicted number of accrued subjects during the pre-specified accrual period, and the probability of achieving accrual targets. It relies on a Bayesian accrual prediction model to combine protocol information with real-time trial enrollment data and disseminates results via web application. RESULTS: First released in 2016, the Accrual Prediction Program summarizes enrollment information for active studies categorized by various trial attributes. The web application supports real-time evidence-based decision making for strategic resource allocation and study management of over 120 ongoing clinical trials at the University of Kansas Cancer Center. CONCLUSION: The Accrual Prediction Program makes accessing comprehensive accrual information manageable at an institutional level. Cancer centers or even entire institutions can reproduce the Accrual Prediction Program to achieve real-time comprehensive monitoring and prediction of subject accrual to aid investigators and administrators in the design, conduct, and management of clinical trials.
Entities:
Keywords:
Cancer center; patient recruitment; subject accrual; web-based tool
Authors: Caroline S Bennette; Scott D Ramsey; Cara L McDermott; Josh J Carlson; Anirban Basu; David L Veenstra Journal: J Natl Cancer Inst Date: 2015-12-29 Impact factor: 13.506
Authors: Benjamin Kasenda; Junhao Liu; Yu Jiang; Byron Gajewski; Cen Wu; Erik von Elm; Stefan Schandelmaier; Giusi Moffa; Sven Trelle; Andreas Michael Schmitt; Amanda K Herbrand; Viktoria Gloy; Benjamin Speich; Sally Hopewell; Lars G Hemkens; Constantin Sluka; Kris McGill; Maureen Meade; Deborah Cook; Francois Lamontagne; Jean-Marc Tréluyer; Anna-Bettina Haidich; John P A Ioannidis; Shaun Treweek; Matthias Briel Journal: Trials Date: 2020-08-21 Impact factor: 2.279
Authors: Dinesh Pal Mudaranthakam; Milind A Phadnis; Ron Krebill; Lauren Clark; Jo A Wick; Jeffrey Thompson; John Keighley; Byron J Gajewski; Devin C Koestler; Matthew S Mayo Journal: Contemp Clin Trials Commun Date: 2020-05-27