We represent 7 of the largest contract research organizations (CROs) in the United States. We agree with the authors of the recent commentary on sponsorship of clinical trials1 that all research must be conducted and reported objectively, dispassionately and with the highest levels of scientific accuracy and integrity.
The perception stated in the commentary of “head-to-head” competition between CROs and academic sites is mistaken and does not portray accurately the roles, objectives and operations of CROs in the clinical research process. CROs work on a sponsor's behalf in a highly regulated environment to implement and manage a clinical trial according to the study protocol. They provide research services including consultation regarding study design, facilitation of the recruitment of investigators and study patients, assurance of patient protection and data integrity, and data analysis to maximize the quality of the research, and guidance through the complex regulatory environment. CROs do not sponsor clinical trials, do not own trial data, do not provide routine patient care and do not participate in agreements concerning publication rights and responsibilities, which are negotiated between sponsors and investigators. The CRO's contractual obligation is to ensure the integrity of data and compliance with US Food and Drug Administration and international regulations, not specific results. This enhances, not erodes, the quality and standards of clinical trials.
Both academic and community-based investigators participate in CRO-managed clinical investigations, and many of them participate in the development of study protocols. In CRO-managed studies the investigator is neither our employee nor our customer but rather an integral partner in the research process. The breadth of our research spectrum encourages us to seek the best and brightest physician- scientists across all clinical disciplines.
We maintain that CROs contribute to high-standard clinical research by working with — not competing with — clinical investigators in both academic medical centres and community-based clinics.
Reference
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