Essay: Should Cost Be Considered in the Overall Evaluation of Phase II Clinical Trials of New Antineoplastic Therapies? A Response

Abstract

The recent essay by Markman (1) raises the question of cost in the conduct of phase II clinical trials and appears to imply that cost should be a limiting factor in the development of novel therapies. The specific example of substantial cost discussed was that of dose-intense paclitaxel with G-CSF support. Whereas the basic question is valid, it may be worthwhile to examine in greater detail the specific example cited by Markman. Through such an examination, it might be possible to identify what costs should be considered, what level of improved efficacy may justify such increased costs, and what magnitude of increased cost is acceptable for a given level of improved efficacy. Such a discussion, using this specific example, might form the basis for a standardized approach to clinical treatment strategies in the future. As suggested by Markman, cost considerations should be discussed in the context of clinical efficacy.

Key Words:

• Ovarian cancer
• Paclitaxel
• G-CSF
• Dose intensity