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Indian Journal of Cancer, Vol. 47, No. 1, January-March, 2010, pp. 70 Letter To Editor Phase 0 (Zero) clinical trials: A myth or reality? Jain A Department of Medical Oncology, Kidwai Memorial Institute of Oncology, Bangalore - 600 029, India Code Number: cn10015 PMID: 20071795 DOI: 10.4103/0019-509X.58863 Sir, 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
Copyright 2010 - Indian Journal of Cancer |
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