The ARO-CRO Model in Pharmaceutical and Biotechnology Industries

Historically, Contract Research Organizations (CROs) have played a significant role in the design, execution, monitoring, and data analysis of clinical trials. Most small pharmaceutical and biotechnology companies rely on the services CROs provide in order to conduct national or international clinical trials mostly because without their contribution the companies would not be able to conduct such studies. Nevertheless, it’s becoming more and more common for large companies to subcontract their researches to CROs in order to lower operational costs and expedite their investigations by hiring experts in design, execution, and oversight of clinical trials. This partnership between pharmaceutical/biotechnology companies and CROs has been the conventional or standard system in industry-sponsored clinical trials and, so far, it has delivered excellent results. However, some critics argue that the current interaction among sponsors, CROs, and academic experts—which also play an important but limited role in the oversight and safety monitoring of clinical trials—does not ensure the integrity and transparency of the studies and does not support the interests of patients, clinicians, and regulatory agencies. This is why Goldenberg et al. (2011) proposes a new and improved model for independent oversight in industry-sponsored clinical trials: the Academic Research Organization-Contract Research Organization (ARO-CRO) model. This new structure is intended to integrate academicians to work hand-in-hand with CROs in the whole process of drug development and give them more responsibilities that they normally have when they form part of conventional steering committees or data and safety monitoring boards.

The Ideas Behind the ARO-CRO Model

Large industry-sponsored clinical trials are typically managed by the study’s sponsor, a Contract Research Organization (CRO) and a steering committee constituted by academic experts. Main control of the trial’s design, monitoring, and execution rest in the hands of the sponsor and the CRO; academicians play a significant role as they are also responsible of oversight and safety monitoring, however, their work depends on the structure of the interaction between the sponsors and the CRO and on the data that is made available to them as they not always have complete access to the study’s data. This is why Goldenberg et al. argue that the integration of an independent non-profit data and safety monitoring board would satisfy the need for integrity, efficient monitoring, and transparency. This non-profit board would be an Academic Research Organization (ARO).

Goldenberg et al. does not propose to completely eliminate CROs but to integrate AROs to the whole picture and to create a collaborative structure between them. The idea is to have a wide array of academicians from different institutions to avoid any conflict of interest and to ensure the integrity of the oversight process. The ARO would have some unique functions and other shared responsibilities but their oversight, evaluation, and analysis would be independent from the CRO. Some of their unique responsibilities—which in my opinion would provide great benefits—include: verification of statistical findings, mentoring of young investigators, and reporting or follow-up data.

The ARO-CRO model represents a great alternative to the conventional model as it provides an efficient way to integrate an independent non-profit organization to support the oversight of such studies. This new proposed mechanism could help address the integrity and ethical issues surrounding clinical trials. While do not consider that the “lack of expertise” of CROs it’s the reason why the ARO-CRO model should be implemented I do think the model would be strongly beneficial for both patients and sponsors. Maybe a gradual integration of AROs in clinical trials would be the best way to start implementing this model. 

Reference:

Goldenberg, N.A., et al. (2011). Improving academic leadership and oversight in large industry-sponsored clinical trials: The ARO-CRO model. Blood, 117(7), 2089-2092. doi:10.1182/blood-2010-09-308858