International Interventional Clinical Studies: NCCAM Special Considerations

July 2012

Summary: In general, the National Center for Complementary and Alternative Medicine (NCCAM) support of investigator-initiated clinical trials that study an intervention delivered to human subjects will be limited to studies carried out within the United States and Canada, except in special settings (see Special Considerations below). NCCAM will continue to support highly meritorious international grants that propose non-interventional, observational, or epidemiologic clinical studies, as well as basic mechanistic and non-clinical translational research.

Background: Interest in research on complementary health practices, including interventions derived from systems of traditional medicine, is worldwide. Over the years, NCCAM has received inquiries about, and has periodically supported, investigator-initiated interventional clinical studies outside of the United States and Canada. However, these studies have proven to be extremely resource-intense because of: 1) the complexity and heterogeneity of global regulatory frameworks and social policies governing complementary health practices, and 2) the wide range of experience in clinical trials within the international complementary health research community.

Given the resulting scientific and regulatory challenges involved in designing, implementing, and overseeing interventional clinical studies outside of the United States and Canada, and available staff resources and funding, NCCAM must limit its support of interventional clinical trials in order to ensure necessary focus on investments in current strategic priorities of the Center.

Special Considerations: Special consideration may be given to: 1) applications for support of interventional clinical trials that are responsive to NCCAM funding opportunity announcements that specifically allow international studies, or 2) applications that are based in well-established international collaborations with extensive experience and a proven track record of success in carrying out international interventional clinical trials in other fields of investigation. 

Prior to submitting such applications for NCCAM support of interventional clinical studies that would be conducted outside of the United States and Canada, investigators must contact the appropriate program officer to discuss NCCAM interest in and willingness to support the project. Among factors to be considered by NCCAM are the following:

• The strength of preexisting and independently funded clinical research infrastructure at the proposed clinical site(s)
• The scope and nature of previous experience of the principal investigator (PI) and site staff in conducting collaborative, international interventional clinical trials in the proposed country and at the proposed site(s)
• Previous experience of the PI in working with all relevant U.S. and foreign regulatory authorities and complying with their requirements
• The need for and/or status of required U.S. and foreign regulatory approvals
• The needs and plans for data and safety monitoring in the country, including both an oversight monitoring committee and regular site auditing.