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A Justifiable Objective

Arch Intern Med. 2006;166:1446-1448.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

INTRODUCTION

Much has been written over the past decade regarding the ethics of phase 1 studies in patients with malignant disease.^1-8 A primary focus of this literature has been on the expressed concern that patients, and often their physicians, "misinterpret" the fundamental aims of such studies, believing either consciously, or unconsciously, that participation will be of direct clinical benefit to the research subject. Rather, the argument goes, the purpose of phase 1 trials is to "determine the metabolism and pharmacologic actions of the drug in humans, the adverse effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness,"⁹ information that will hopefully be of benefit to future patients.

To support their argument, commentators have pointed to a number of analyses that documented that fewer than 5% to 6% of patients who enter phase 1 anticancer trials experience biological evidence of tumor regression (ie, "partial" or "complete" response).^10-15 . . . [Full Text of this Article]

UNDERSTANDING THE DEFINITION OF PHASE 1 CLINICAL TRIALS AS APPLIED TO ONCOLOGY

ADMINISTRATION OF A COMBINATION OF ESTABLISHED AND INVESTIGATIVE ANTICANCER AGENTS

ANTICIPATED DEVELOPMENT OF NOVEL BIOLOGIC AGENTS THAT HAVE A HIGH PROBABILITY OF ACHIEVING TUMOR REGRESSION

PUBLISHED DATA

CONCLUSIONS

AUTHOR INFORMATION

Maurie Markman, MD

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