In this issue of Clinical Cancer Research, we are pleased to introduce a new feature titled CCR Perspectives in Drug Approval. This feature will incorporate the popular Report from the FDA but will evolve to include perspectives from other regulatory groups addressing broad topics that affect the drug approval process, as well as discussions of how national regulatory bodies are approaching the challenges inherent in evaluating the value of novel anticancer therapies.
Fundamental scientific discoveries that contribute to a deeper understanding of oncogenesis and the identification of novel targets that may lead to the development of new drugs and other therapeutic strategies for cancer therapy continue to emerge at an ever-increasing pace. It is clear that the drug approval process must also evolve to accommodate our increasingly detailed understanding of cancer. In addition to this scientific revolution, drug evaluation and approval is now an international endeavor, with various criteria for drug approval being established across the globe. Even greater complexity is added when one considers the escalating costs of novel anticancer treatments, and the fact that many of these agents may extend survival only very slightly for patients with a short overall life expectancy. Thus, assessing the value of new cancer treatments is very difficult and at times very controversial.
Ultimately, our goal is to provide a scientific/scholarly forum for communicating these challenging issues to the oncology community. To lead off the CCR Perspectives in Drug Approval feature, Peter Littlejohns and colleagues of the National Institute for Health and Clinical Excellence (NICE) will describe the Institute's role in assessing the value of new cancer treatments in England and Wales. We hope our readership will find these articles useful, and would be happy to receive any feedback on this new feature.
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