ACRO calls for sufficient resources for FDA to monitor foreign clinical trials

The Association of Clinical Research Organizations, which represents the global CRO industry, today released the following statement regarding a report from the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) titled Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials.

"ACRO supports the recommendations outlined in the HHS report, and we have been actively advocating for increased funding for the FDA's Office of International Programs (OIP) to provide the agency with sufficient resources to ensure research quality is maintained around the world. The association continues to encourage development of a robust global research infrastructure to facilitate accelerated drug development.

"Our members are committed to the highest levels of patient safety and research quality and are global leaders in adherence to good clinical practice (GCP) principles set by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). CROs train research staff around the world in GCP principles and proof of compliance is required by drug regulators in every major pharmaceutical market. The association believes that all participants in clinical research - no matter where they live or the environment in which research takes place - must be protected by the same level of safety, ethical considerations and standards of care.

"We promote efforts to strengthen the globalization of the clinical research enterprise in order to speed the development of life-saving medicines and treatments for patients who need them. Findings from a July 2009 study concluded that globalized trials can reduce development time by more than half while maintaining quality and safety. ACRO will continue its efforts to collaborate with stakeholders around the world to enhance clinical development and encourage clinical research participation."