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Year : 2010  |  Volume : 47  |  Issue : 1  |  Page : 70

Phase 0 (Zero) clinical trials: A myth or reality?

Department of Medical Oncology, Kidwai Memorial Institute of Oncology, Bangalore - 600 029, India

Date of Web Publication12-Jan-2010

Correspondence Address:
A Jain
Department of Medical Oncology, Kidwai Memorial Institute of Oncology, Bangalore - 600 029
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0019-509X.58863

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How to cite this article:
Jain A. Phase 0 (Zero) clinical trials: A myth or reality?. Indian J Cancer 2010;47:70

How to cite this URL:
Jain A. Phase 0 (Zero) clinical trials: A myth or reality?. Indian J Cancer [serial online] 2010 [cited 2021 Dec 1];47:70. Available from: https://www.indianjcancer.com/text.asp?2010/47/1/70/58863


Phase 0 trials are the first human trials with no therapeutic or diagnostic intent, with a limited number of patients (less than 15) and with limited drug exposure (drug doses are much lower than those used in Phase I clinical trials). [1] In phase 0 trials the drugs with wider therapeutic index can be evaluated pharmacodynamically (PD) if the agent inhibits the intended target, and the drugs with narrow therapeutic index can be evaluated pharmacokinetically if they achieve adequate drug levels. The phase 0 trials can decrease the total cost of drug development in a significant manner because the failure rate of a new oncology drug is about 90%. [2] Recently published recommendations on the development of phase 0 (Zero) clinical trials from the task force on the Methodology for the Development of Innovative Cancer Therapies (MDICT), have eloquently explained the methodology to conduct phase 0 trials . [3]

The problems of phase 0 trials are poor recruitment of patients because of lack of therapeutic benefit, and the development of strong PD markers before the start of phase 0 trials is cumbersome and expensive.

The concept of phase 0 trials is encouraging for pharmaceutical industries in developing countries because of the significant decrease in the total cost of new drug development.

If successful in Oncology drug development, phase 0 trials can open new horizons for developmental therapeutics in other fields of Internal Medicine also..

  References Top

1.US Department of Health and Human Services, Food and Drug Administration. Guidance for industry, investigators, and reviewers, exploratory IND studies. January 2006. Available from: .  Back to cited text no. 1      
2.Kola I, Landis J. Can the pharmaceutical industry reduce the attrition rates? Nat Rev Drug Discov 2004;3:711-5.   Back to cited text no. 2  [PUBMED]  [FULLTEXT]  
3.Kummar S, Doroshow JH, Tomaszewski JE, Calvert AH, Lobbezoo M, Giaccone G, et al. Phase 0 (Zero) clinical trials: Recommendations from the task force on methodology for the development of innovative cancer therapies. Eur J Cancer 2009;45:741-6.  Back to cited text no. 3  [PUBMED]  [FULLTEXT]  


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