Year: 2008
Type: letter
Abstract: We agree with the concepts that phase I studies should be designed to take advantage of the opportunity to observe clinical activity early in drug development, and that biologic markers of clinical activity should be used to help with identification of the OTD.However, proven biomarkers for human epidermal growth factor receptor 2 inhibition are still not readily available.7 Intracellular phosphorylation markers require serial biopsies and tissue sample processing, which are difficult to execute.In the absence of a valid or technically feasible biomarker, assessing a targeted drug may seem to follow the cytotoxic paradigm until sufficient clinical activity data are obtained to enable more rational study design and dose definition.The optimal design of clinical trials with targeted agents, alone or in combination with cytotoxic agents, requires a balance between the theory of best practice and the reality of the limitations of what patient volunteers can accommodate, available technology, and resources for implementation.Hurdles in drug development need to be understood by health care providers, especially those involved as investigators, who are in a position to help overcome them, so we can achieve our common goal of improving patient care.
Source: Journal of Clinical Oncology
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: bronze
OpenAlex ID: W4238743695