Cereals & Grains Association
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Contract research organization perspective
C. COOK (1). (1) Biofortis Clinical Research, Addison, IL, U.S.A.

A Contract Research Organization (CRO) is a for-profit company specializing in the conduct of clinical trials. Originally, CROs provided clinical trial support services for the pharmaceutical development process, primarily in regulatory compliance to ensure human trials met the standards put forth by the Food and Drug Administration (FDA). Over time, CROs have expanded to include all aspects of clinical trial design and execution, while maintaining expertise in the stringent regulatory requirements for new drug development. CROs also offer the advantage of confidentiality as well as speed, due to efficiencies with respect to consolidation of resources and expertise in data management. As such, the use of CROs has extended beyond drug development to other industries, including food, with some CROs specializing in studies that aim to evaluate the safety and efficacy of food ingredients, packaged food products and dietary supplements. This shift in paradigm raises new issues with respect to conflict of interest and bias. For example, unlike most academic institutions, publication of study results is not a requirement, which may influence the integrity of study design as well as lead to bias in the scientific literature. Inherent to this issue is a lack of incentive to register the trial with a National or International registry, which is now a requirement of many peer-reviewed journals. Further, the CRO may be subject to be pressure from the sponsoring company to conduct multiple post-hoc analyses in an attempt to achieve more favorable efficacy or safety results than were determined by the <i>a priori</i> statistical plan. Adhering to clinical trial standards and following the principles of transparency and integrity minimizes the potential for conflict of interest in CROs, reducing bias and increasing scientific credibility for all stakeholders.

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