Design and results of phase I cancer clinical trial: three- Stat Med. 1994;13: 1799-1806. studies. Stat Med

Purpose: Alternatives to the standard design for con-ducting phase I trials are proposed with increasing fre-quency. This study was undertaken to determine how phase I trials are currently conducted and to provide a basis for evaluation of evolving methodology. Subjects and Methods: All published phase I trials from a single institution over a 3-year period were re-viewed to determine the method of selection of the rec-ommended dose for a phase II trial of a new agent, type and extent of toxicity, number of patients treated at the recommended dose, and clinical response. Results: All 23 published trials used the standard method of entering cohorts of patients at increasing dose levels and observing toxic effects to determine the dose recommended for phase II study. Among 610 patients