Tracey Blog: Guidance for Industry: Acceptance of Foreign Clinical Studies

The Guidance for Industry: Acceptance of Foreign Clinical Studies was released as a final guidance in March 2001. This guidance can be found online at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm124939.pdf.

Target Audience:

The sponsor (financial supporter, often a pharmaceutical company) of a clinical trial

Laws and Regulations Referenced:

• Title 21 of the Code of Federal Regulations, part 312 (Investigational New Drug Application [IND]); referred to as 21 CFR Part 312.
• Title 21 of the Code of Federal Regulations, part 812 (Investigational Device Exemptions [IDE]); referred to as 21 CFR Part 812.
• Title 21 of the Code of Federal Regulations Part 814 (Premarket Approval of Medical Devices)

Rationale:

In the United States prior to testing new drugs or devices on humans the FDA requires sponsors to complete an Investigational New Drug Application (IND) for drugs or an Investigational Device Exemption (IDE) for a medical device. The regulations for clinical studies conducted under an IND or IDE, including ethical standards the FDA expects to be followed during the conduct of these clinical trials, are described in Title 21 CFR Part 312 and Part 812, respectively.

In general, the international medical community adheres to the ethical principles outlined in the Declaration of Helsinki. This declaration was originally adopted by the World Medical Association’s in 1964 and has since been revised 5 times. With each new version the FDA assesses the changes and decides whether the relevant regulations should be updated. At this time, the regulation for INDs (21 CFR Part 312) incorporates language from the 1989 version of the declaration; the regulation for IDEs (21 CFR Part 814 incorporates the 1983 version of the Declaration of Helsinki.

Studies conducted outside the United States may or may not be conducted under an IND or IDE. The FDA has written Guidance for Industry: Acceptance of Foreign Clinical Studies to provide their expectations with regards to the ethical treatment of people participating in clinical studies conducted in countries other than the United States.

Recommendations:

Foreign studies conducted under and IND or IDE must comply with the same regulations as those conducted in the United States. However, the FDA will also accept foreign studies that were not conducted under an IND if they adhere to the ethical standards outlined in the 1989 version of the Declaration of Helsinki. Studies conducted under an IDE will be accepted if they adhere to the ethical standards outlined in the 1983 version of the Declaration of Helsinki. Both types of studies will be accepted by the FDA if they were conducted using the ethical principles of local regulatory authorities if their principles provided greater participant protection than the declaration.

Impact:

As more clinical trials are being conducted the competition for study participants is also increasing. In addition, research is being conducted on diseases that do not occur in this country. In these cases clinical studies may be conducted in the location where the disease is found. As a result, sponsors are going into countries where there may be little or no oversight regarding the ethical treatment of study participants. Therefore, this guideline is essential. Although most sponsors of drugs and devices are ethical, for those who might be motivated by money to cut corners that might but study participants at risk, the FDA is forcing them to put people first. With this guidance the FDA is making a statement: follow the guidelines or risk spending a lot of money on data that cannot be used to support approval of a drug or medical device.