ISO/TC 157/WG 20 - Clinical trials

ISO 11249:2018 provides guidance on the design and conduct of clinical studies to determine the performance characteristics of new intrauterine devices. It also provides advice on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers, researchers and regulatory bodies. ISO 11249:2018 is intended to ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, and to assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. Certain clinical trial concerns are not addressed in this document, including subject compensation, confidentiality of subjects and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in great detail in ISO 14155.

ISO 29943-2:2017 is intended to help in the design, execution, analysis, and interpretation of clinical function studies conducted in accordance with the requirements of ISO 25841 for female condoms. These clinical studies compare the performance of a new female condom to an established female condom during vaginal intercourse (not anal intercourse). In particular, these studies are designed to assess acute failure events during use. ISO 29943-2:2017 also provides direction on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers and regulatory bodies. Certain clinical trial elements are not addressed in this document, including compensation, confidentiality of individuals and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in greater detail in ISO 14155.

ISO 29943-1:2017 is intended to help in the design, execution, analysis and interpretation of clinical function studies conducted in accordance with the requirements of ISO 23409 for male synthetic condoms. These clinical studies compare the performance of a new male condom to an established male condom during vaginal intercourse (not anal intercourse). In particular, these studies are designed to assess acute failure events during use (i.e. clinical slippage and clinical breakage). ISO 29943-1:2017 also provides direction on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers and regulatory bodies. Certain clinical trial elements are not addressed in this document, including compensation, confidentiality of individuals and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in greater detail in ISO 14155.