1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer [
online
], (2004).
2. Fujiwara, Y. Future perspectives of registration-directed clinical trials from the standpoint of large academic hospital [Japanese]. Farumashia 44, 789–794 (2008).
3. UMIN Clinical Trials Registry [
online
], (2009).
4. JMACCT Clinical Trial Information Registration [
online
], (2009).
5. US Department of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs: Guidance for Industry: Guideline for the Monitoring of Clinical Investigations [
online
], (1998).