The National Academies Press

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Introduction
Pages 1-2

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From page 1... ... Only a small percentage of drug candidates ultimately become useful therapies. The novel and more mechanistically based cancer drugs may be even more inclined to fail traditional clinical trials, which are not tailored to the combination testing that may be required, or to the different standards or procedures needed when The planning committee's role was limited to planning the workshop, and the work shop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Read the entire page →
From page 2... ... and Phase 0 trials, adaptive trials, trials that target mul tiple pathways with multiple drugs, and preclinical model systems that better inform clinical studies • Molecular imaging, including molecular imaging strategies in drug development and how they can facilitate clinical trials • Screening for predictive markers • Collaborations among academia, the pharmaceutical or diagnostics industries, and government, including ways to reduce the costs and regulatory burdens of clinical trials and increase patient accruals • Regulatory issues, including the laws, regulations, and policies that help or hinder improvements in cancer clinical trials In addition, participants in five small-group discussions explored the following topics: • Phase 0 trials • Adaptive trial design • Imaging • Use of proteomics/genomics to assign therapy in lung cancer • Use of genetics/genomics to assign therapy This document is a summary of the conference proceedings, which will serve as input to the deliberations of an Institute of Medicine committee Read the entire page →

From page 1...

... Only a small percentage of drug candidates ultimately become useful therapies. The novel and more mechanistically based cancer drugs may be even more inclined to fail traditional clinical trials, which are not tailored to the combination testing that may be required, or to the different standards or procedures needed when The planning committee's role was limited to planning the workshop, and the work shop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop.

Read the entire page →

From page 2...

... and Phase 0 trials, adaptive trials, trials that target mul tiple pathways with multiple drugs, and preclinical model systems that better inform clinical studies • Molecular imaging, including molecular imaging strategies in drug development and how they can facilitate clinical trials • Screening for predictive markers • Collaborations among academia, the pharmaceutical or diagnostics industries, and government, including ways to reduce the costs and regulatory burdens of clinical trials and increase patient accruals • Regulatory issues, including the laws, regulations, and policies that help or hinder improvements in cancer clinical trials In addition, participants in five small-group discussions explored the following topics: • Phase 0 trials • Adaptive trial design • Imaging • Use of proteomics/genomics to assign therapy in lung cancer • Use of genetics/genomics to assign therapy This document is a summary of the conference proceedings, which will serve as input to the deliberations of an Institute of Medicine committee

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Introduction Pages 1-2

Introduction
Pages 1-2