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
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