title: Contract research organizations in oncology clinical research: Challenges and opportunities.
abstract: Contract research organizations (CROs) represent a multibillion dollar industry that is firmly embedded in the contemporary clinical trial process. Over the past 30 years, and especially within the last decade, the reach of CROs has extended to service all phases of drug trials in an increasingly global research environment. The presence of CROs is particularly noticeable in medical oncology because of the large number of investigational compounds developed to treat cancer that are currently undergoing testing in human subjects. Although limited data are available with which to objectively define the effects that CROs have had on the clinical trial process, with the expansion of these organizations, several reports have called into question whether ethical and professional standards in research conduct are at times secondary to economic considerations. CROs can add considerable value to the clinical trial process, but difficulty communicating with CRO representatives and time spent answering trivial data queries generated by CROs are current obstacles for study site personnel interacting with CROs. Further study of the effect of the CRO industry on the clinical trial process is needed to ensure efficient data collection and patient safety while collaboratively developing novel therapies in an expedited fashion. Cancer 2016;122:1476-82. © 2016 American Cancer Society.
authors.affiliation: Department of Medicine, Saint Vincent Hospital, Worcester, Massachusetts.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Roberts
authors.affiliation: Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Hagop M
authors.initials: HM
authors.lastname: Kantarjian
authors.affiliation: Division of Hematological Malignancies, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
authors.forename: David P
authors.initials: DP
authors.lastname: Steensma
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000458:organization & administration; D003142:Communication; D003284:Contract Services / Q000379:methods* / Q000458:organization & administration; D006801:Humans; D008495:Medical Oncology / Q000379:methods* / Q000458:organization & administration
keywords: clinical trial; contract research organizations; drug trial; ethics