TAG ARCHIVES FOR clinical trial data

18
Sep2019

The International Conference of Harmonization (ICH), which is made up of the regulatory bodies and pharmaceutical trade associations of key drug developing countries, recently released their  revised “E8(R1) General Considerations for Clinical Studies” document. On September 16, PRIM&R submitted comments approving of ICH’s work to modernize their guidelines and suggesting that the document could benefit from a better discussion of the broad ethical principles that underlie many of the human subject protections the document details. We also recommend that the ICH consider reorganizing some of its guidelines to make it easier for those designing and conducting research to learn more about these fundamental ethical principles and related best practices. If you are based in the United States, we encourage you to consider submitting your own comments on the newly revised E8 document before the September 30 deadline. You are welcome to cite or quote PRIM&R’s comments. Read more