Take Home Points: Introduction

After reviewing the Introduction's Basic Concepts and Introduction Section of the Protocol Roche M66001E, here are some important "Take Home" points:

• Regulatory guidance from International Conference on Harmonization (ICH), the U.S. Code of Federal Regulations (for studies conducted under an IND) and other groups define components that must be included in the research protocol.
• It is essential to acknowledge that an inherent imbalance of power exists between the researcher and study participant. This can be addressed, in part, through effective participant education about the trial and full disclosure of the risks and benefits of participation.
• Ethics inform regulation. Eight ethical principles and benchmarks for multinational research proposed by Emmanuel and colleagues underpin much of the regulatory framework governing clinical trial conduct.
• While significant advances have been made, scientific and operational obstacles continue to thwart anti-cancer drug development. As new targeted therapies, based on rational drug design, reach late phase testing, improved understanding of targets known to play a key role in cancer cell growth and survival. will be critical to the future of anti-cancer drug discovery.
• Improved coordination of the global research effort is needed. In addition, adequate resources from public and private stakeholders must be committed to support coordination and to fund basic science,drug design, standardization of monitoring, and clinical trial capacity.