Improving academic leadership and oversight in large industry-sponsored clinical trials: the ARO-CRO model.
Standards for clinical trial design, execution, and publication have increased in recent years. However, the current structure for interaction among the pharmaceutical sponsor funding a drug or device development program, the contract research organization (CRO) that typically assists in executing the trial, regulatory agencies, and academicians, provides inadequate leadership and oversight of the development process. Conventional academic steering committees are not provided with the independent infrastructure by which to verify statistical analyses and conclusions regarding safety and efficacy. We propose an alternative approach centered on partnerships between CROs and university-based academic research organizations (AROs). In this model, the ARO takes responsibility for processes that address journal requirements and regulatory expectations for independent academic oversight (including oversight of Steering Committee and Data and Safety Monitoring Board activities), whereas the CRO provides infrastructure for efficient trial execution, site monitoring, and data management. The ARO engages academic experts throughout the trial process and minimizes conflicts of interest in individual industry relationships via diversification of sponsors, agents, and therapeutic areas. Although numerous models can be entertained, the ARO-CRO model is uniquely structured to meet the demand for greater assurance of integrity in clinical trials and the needs of each stakeholder in the process.
Department of Medicine, Section of Hematology/Oncology, University of Colorado, Aurora, CO, USA.
Neil A
NA
Goldenberg
Alex C
AC
Spyropoulos
Jonathan L
JL
Halperin
Craig M
CM
Kessler
Sam
S
Schulman
Alexander G G
AG
Turpie
Allan M
AM
Skene
Neal R
NR
Cutler
William R
WR
Hiatt
D000046:Academic Medical Centers; D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic / Q000191:economics / Q000941:ethics / Q000592:standards; D016265:Conflict of Interest; D003284:Contract Services; D004345:Drug Industry / Q000191:economics; D033161:Government Regulation; D006801:Humans; D007857:Leadership; D017146:Models, Organizational; D055818:Public-Private Sector Partnerships