1. Twombly R. Slow start to phase 0 as researchers debate value. J Natl Cancer Inst 2006; 98(12): 804–806.
2. Guidance for industry, investigators, and reviewers. Exploratory IND studies. U.S. department of health and human services. Food and drug administration. Center for drug evaluation and research (CDER). January 2006.
3. Kola L, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 2004; 3(8): 711–715.
4. Kinders R, Parchment RE, Ji J et al. Phase 0 clinical trials in cancer drug development: from FDA guidance to clinical practice. Mol Interv 2007; 7(6): 325–334.
5. European Medicines Agency, Committee for medicinal products for human use. Position paper on non-clinical safety studies to support clinical trials with a single microdose. London, June 23, 2004.
6. Bertino JS Jr, Greenberg HE, Reed MD. American colleague of clinical pharmacology position statement on the use of microdosing in the drug development process. J Clin Pharmacol 2007; 47(4): 418–422.
7. Kummar S, Kinders R, Rubinstein L et al. Compressing drug development timelines in oncology using phase “0” trials. Nat Rev Cancer 2007; 7(2): 131–139.
8. Johnson JI, Decker S, Zaharevitz D et al. Relationships between drug activity in NCI preclinical in vitro and in vivo models and early clinical trials. Br J Cancer 2001; 84(10): 1424–1431
9. Von Hoff DD, Turner J. Response rates, duration of response, and dose response effects in phase I studies of antineoplastics. Invest New Drugs 1991; 9(1): 115–122.
10. Abdoler E, Taylor H, Wendler D. The ethics of phase 0 oncology trials. Clin Cancer Res 2008; 14(12): 3692–3697.
11. Pocard M, Soria JC, Aldaz-Carroll L et al. Phase 0 clinical trials in oncology: an exploratory methodology for constructing a study with patients undergoing surgery for metastatic disease. J Clin Oncol 2010; 28(30): 4551–4553.
12. Kummar S, Kinders R, Gutierrez ME et al. Phase 0 clinical trial of the poly (ADP-ribose) polymerase inhibitor ABT-888 in patients with advanced malignancies. J Clin Oncol 2009; 27(16): 2705–2711.