Document Detail


Improving academic leadership and oversight in large industry-sponsored clinical trials: the ARO-CRO model.
MedLine Citation:
PMID:  21068436     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Neil A Goldenberg; Alex C Spyropoulos; Jonathan L Halperin; Craig M Kessler; Sam Schulman; Alexander G G Turpie; Allan M Skene; Neal R Cutler; William R Hiatt;
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2010-11-10
Journal Detail:
Title:  Blood     Volume:  117     ISSN:  1528-0020     ISO Abbreviation:  Blood     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-02-18     Completed Date:  2011-03-31     Revised Date:  2013-07-03    
Medline Journal Info:
Nlm Unique ID:  7603509     Medline TA:  Blood     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2089-92     Citation Subset:  AIM; IM    
Affiliation:
Department of Medicine, Section of Hematology/Oncology, University of Colorado, Aurora, CO, USA.
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MeSH Terms
Descriptor/Qualifier:
Academic Medical Centers
Clinical Trials Data Monitoring Committees
Clinical Trials as Topic* / economics,  ethics,  standards
Conflict of Interest
Contract Services
Drug Industry* / economics
Government Regulation
Humans
Leadership
Models, Organizational*
Public-Private Sector Partnerships
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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