Practical Problems in the Conduct of Non-US Studies from Which Data Will Be Used for US Registration

The use of clinical data generated outside the United States in US drug registration is becoming more common. In order for the FDA to accept such data, various requirements must be met by the study sponsor and investigators. Difficulties in meeting these requirements often arise in the areas of ethical review, patient informed consent, general record-keeping, and access to clinical records for audit purposes. Clear communication between the sponsor and investigator regarding regulatory requirements is the single most important factor for the success of these studies. Problems that are commonly experienced are identified and practical approaches to these problems are discussed.