TAG ARCHIVES FOR drug trials


Expanded access, which is treatment access to experimental drugs (also referred to as "compassionate use" or "pre-approval access"), has generated increasing interest and debate over the last several years. Currently, US federal regulations allow manufacturers to provide Investigational New Drugs (INDs) to patients with serious diseases or conditions who have exhausted approved therapeutic options, and cannot participate in a clinical trial. As key players in the pre-approval access process, IRBs must review and approve expanded access protocols in accordance with FDA guidelines. Moreover, the new “Right to Try” laws currently taking effect on both the federal and state levels make it especially crucial that IRB members stay informed about ongoing developments and potentially thorny ethical issues. Read more


This week’s Research Ethics Roundup covers President Trump’s call for removing a majority of FDA regulations, the argument for calling for efficacy data before human research begins, USDA’s decision to remove Animal Welfare Act records, and FDA’s case for conducting phase three testing. Read more