Annals of Pharmacotherapy, Ahead of Print.
Clinical research used to substantiate Food and Drug Administration (FDA) drug approval is increasingly being conducted overseas. One of the enticements to move overseas is unequal oversight by the FDA, and these differences can result in poor quality research and human subject risk. Downstream, patients, clinicians, and payers of health care can be harmed by inaccuracies in the new drug approval process. The need of the hour is to bridge the gap in the standards by ensuring that the investigators in the developing countries adhere to the same quality standards as the domestic investigators.
Clinical research used to substantiate Food and Drug Administration (FDA) drug approval is increasingly being conducted overseas. One of the enticements to move overseas is unequal oversight by the FDA, and these differences can result in poor quality research and human subject risk. Downstream, patients, clinicians, and payers of health care can be harmed by inaccuracies in the new drug approval process. The need of the hour is to bridge the gap in the standards by ensuring that the investigators in the developing countries adhere to the same quality standards as the domestic investigators.
