extract: Balancing Access and Evaluation in the Approval of New Cancer Drugs, June 8, 2011 — JAMA (patient safety etc)

".....Patients with cancer who lack effective treatment desperately seek novel interventions that might extend their lives. They do not have time to wait for the US Food (blogger's note - or any other nation) and Drug Administration's (FDA’s) regular approval process, which requires that sponsors demonstrate “substantial evidence of clinical benefit (or efficacy) from adequate and well-controlled investigations.”........