title: Future vision for the quality assurance of oncology clinical trials.
abstract: The National Cancer Institute clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based process improvements for clinical oncology patient care. The cooperative groups are undergoing a transformation process as we further integrate molecular biology into personalized patient care and move to incorporate international partners in clinical trials. To support this vision, data acquisition and data management informatics tools must become both nimble and robust to support transformational research at an enterprise level. Information, including imaging, pathology, molecular biology, radiation oncology, surgery, systemic therapy, and patient outcome data needs to be integrated into the clinical trial charter using adaptive clinical trial mechanisms for design of the trial. This information needs to be made available to investigators using digital processes for real-time data analysis. Future clinical trials will need to be designed and completed in a timely manner facilitated by nimble informatics processes for data management. This paper discusses both past experience and future vision for clinical trials as we move to develop data management and quality assurance processes to meet the needs of the modern trial.
authors.affiliation: Quality Assurance Review Center Lincoln, RI, USA ; Department of Radiation Oncology, University of Massachusetts Medical School Worcester, MA, USA.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Fitzgerald
authors.forename: Maryann
authors.initials: M
authors.lastname: Bishop-Jodoin
authors.forename: Walter R
authors.initials: WR
authors.lastname: Bosch
authors.forename: Walter J
authors.initials: WJ
authors.lastname: Curran
authors.forename: David S
authors.initials: DS
authors.lastname: Followill
authors.forename: James M
authors.initials: JM
authors.lastname: Galvin
authors.forename: Richard
authors.initials: R
authors.lastname: Hanusik
authors.forename: Steven R
authors.initials: SR
authors.lastname: King
authors.forename: Michael V
authors.initials: MV
authors.lastname: Knopp
authors.forename: Fran
authors.initials: F
authors.lastname: Laurie
authors.forename: Elizabeth
authors.initials: E
authors.lastname: O'Meara
authors.forename: Jeff M
authors.initials: JM
authors.lastname: Michalski
authors.forename: Joel H
authors.initials: JH
authors.lastname: Saltz
authors.forename: Mitchell D
authors.initials: MD
authors.lastname: Schnall
authors.forename: Lawrence
authors.initials: L
authors.lastname: Schwartz
authors.forename: Kenneth
authors.initials: K
authors.lastname: Ulin
authors.forename: Ying
authors.initials: Y
authors.lastname: Xiao
authors.forename: Marcia
authors.initials: M
authors.lastname: Urie
keywords: Clinical Trials Cooperative Group Program; National Cancer Institute; oncology clinical trials; quality assurance; radiation oncology