ARO-CRO Model in Clinical Trials

ARO-CRO Model in Clinical Trials

1. Definition & overview

• The ARO-CRO model is a hybrid trial-conduct structure in which an Academic Research Organization (ARO) supplies independent academic leadership and scientific oversight while a Contract Research Organization (CRO) supplies operational infrastructure and execution capacity for a (usually large, industry-sponsored) clinical trial — the two operating in a defined partnership rather than as substitutes (Goldenberg NA et al., Blood 2010;117:2089–92 [PMID 21068436]).
• A Contract Research Organization (CRO) is, per ICH-GCP E6(R2) §1.20, "a person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions" — i.e. an outsourced agent acting under the sponsor's authority (ICH-GCP E6(R2) §1.20 [ICH]).
• An Academic Research Organization (ARO) is a university-based, academic and/or non-profit entity that performs one or more functions in the conduct of clinical trials — ranging from academic leadership alone to full-service trial management (protocol design, site monitoring, data management, statistical analysis, safety monitoring, endpoint/clinical-events adjudication) (Goldenberg NA et al. 2010 [PMID 21068436]).
• KDT frames the backdrop: new-drug development is "highly complex, tedious, competitive, costly and commercially risky"; a new drug takes ≥10 years and 500–1000 million US$, so development is feasible only within large pharmaceutical houses with the resources, infrastructure and dedicated scientist teams to run the specialized stages — the economic driver that pushes sponsors to outsource trial conduct to CROs/AROs (KDT 8e Ch.5, p.88).
• A clinical trial is "a prospective, ethically designed investigation in human subjects to objectively discover/verify/compare the results of two or more therapeutic measures" — the activity that the sponsor, CRO and ARO are jointly delivering (KDT 8e Ch.5, p.84).
• The sponsor retains ultimate responsibility: under ICH-GCP E6(R2) §5.2, a sponsor "may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor"; any transferred duty must be specified in writing (ICH-GCP E6(R2) §5.2 [ICH]).
• The model is, in essence, an answer to a governance problem — how to retain credible, independent academic oversight and data integrity in trials that are commercially sponsored and operationally run by for-profit vendors (Goldenberg NA et al. 2010 [PMID 21068436]).