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This book presents an overview of the development of targeted therapies for the treatment of cancer with an emphasis on clinical application. The volume covers the complexity of the rapidly developing area of targeted therapies for the treatment of patients with cancer. It is structured in a way so readers may begin with chapters that most interest them and work through the rest of the chapters in the order of their choice.
Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials.
There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.
This outstanding reference source on bone marrow transplantation has become recognised as the bible in the field. This fourth edition has been fully revised to reflect latest developments, and now features over 500 illustrations, including a colour plate section. The need for this new edition cannot be overstated - more than 13,000 new cases per year of haematopoietic stem cell transplantation have been reported to the International Bone Marrow Transplant Registry The original editor, Donnall Thomas, was a pioneer in stem cell research and won the 1990 Nobel Prize for his discoveries concerning organ and cell transplantation in the treatment of human diseases. The book also now includes a fully searchable CD with PDFs of the entire content.
The NCI-sponsored cooperative groups have made important contributions to improving treatment for many types of cancer, including breast, ovarian, colorectal, and childhood cancers. Cooperative group research has been instrumental in establishing innovative treatments that improve outcomes and quality of life. Despite these successes, the Cooperative Group Program has faced a number of challenges that threaten its effectiveness. To address this problem, the National Cancer Policy Forum (NCPF) convened a workshop titled "Multi-Center Phase III Clinical Trials and NCI Cooperative Groups" in Washington, DC, on July 1-2, 2008. The purpose of the workshop was to outline the challenges that the public clinical cancer research enterprise faces, and to identify possible solutions to these challenges.
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