In response to the growing number of clinical trials outsourced to foreign countries in support of market authorizations for drugs and medical devices, Health Canada announced on June 5, 2009 that it is examining the issue of foreign clinical studies to determine if specific guidance in this issue is required1. According to recent reports2, an increasing number of clinical trials are being outsourced to emerging economies such as India, China and Eastern Europe, in order to limit expense and avoid the strict regulations governing research on humans in Canada and in other jurisdictions with advanced medical systems. This trend has caused concern about the quality and applicability of foreign clinical trials, the treatment of patients involved in such studies, and ultimately, whether the results can be relied upon to substantiate the safety and effectiveness requirements for market authorization for drugs and medical devices in Canada.
In the interim, Health Canada has reminded sponsors that clinical study results submitted in support of a Canadian market authorization must be conducted in accordance with internationally recognized Good Clinical Practice standards. In relation to medical devices, Health Canada recognizes the following international standard for the ethical and scientific conduct of clinical research:
- Global Harmonization Task Force (GHTF) ISO TC 194 for the conduct and performance of clinical investigations of in vivo medical devices, which is comprised of ISO 14155-1 (general requirements) and ISO 14155-2 (clinical investigation plans)3.
Health Canada has also advised that when clinical data from studies conducted outside of Canada are included in an application for a Medical Device License or other market authorization, it will scrutinize that data to determine whether the results are considered to be accurate and reliable. If Health Canada has concerns about the data, it will require the sponsor to provide satisfactory evidence to establish that the data was obtained meeting the required recognized standard or an equivalent. The evidence required will be considered on a case by case basis, and if it is not considered to be satisfactory, the market authorization will be refused.
In terms of further guidance on the issue of foreign clinical trials, Health Canada has advised that stakeholders will be consulted as this initiative moves forward, and that further information will be available on the Health Canada Website.