title: Exciting investigator-initiated clinical trials.
abstract: In Japan, the media often announce investigator-initiated clinical trials (IIT). However, experts and reliable information remain limited. As most of the physicians involved do not have enough experience with the development of new medical drugs and devices, they need support from a contract research organization (CRO). The author recently managed two rituximab trials, one for immune thrombocytopenia (ITP) and the other for thrombotic thrombocytopenic purpura (TTP). It is hoped that the present lecture will be useful for investigators who are planning new IIT.
authors: Division of Hematology, Department of General Internal Medicine, Saitama Medical University.
authors: Yoshitaka
authors: Y
authors: Miyakawa
mesh_terms: D035843:Biomedical Research / Q000191:economics; D002986:Clinical Trials as Topic; D006801:Humans; D018579:Patient Selection; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000188:drug therapy*; D011697:Purpura, Thrombotic Thrombocytopenic / Q000188:drug therapy*; D000069283:Rituximab / Q000627:therapeutic use
chemical_list: D000069283:Rituximab