This book describes the principles around which cancer research and clinical trials can be developed. Additionally, by describing the particularities of planning and implementing cancer research in developing countries, this book provides valuable practical information for researchers in resource-rich countries who contemplate cooperating with scientists from limited-resource countries in performing research.Written and edited by leaders in the field who work in these developing countries, Cancer Research and Clinical Trials in Developing Countries: A Practical Guide will appeal to a wide range of researchers, students, and physicians who are engaging in cancer research and clinical trials. It focuses on methodology and statistics while structured around the needs of cancer research. It provides valuable information regarding international collaboration, funding mechanisms as well as publishing and dissemination of research findings.

In 1890, General Francis A. Walker, president of both the Massachusetts Institute of Technology and the American Statistical Association, wrote There is reason to wish that all citizens, from the highest to the lowest, might undergo so much of training in statistics as should enable them to detect the errors lurking in quantitative statements regarding social and economic matters which may … be ad­ dressed to them as voters or as critics of public policies. [E A. Walker, 1890; reprinted in Noether, 1989] It has been more than a century since Walker stated his wish, but progress has been slow, just as advancement in the establishment of statistical principles and methodology has been laborious and difficult over the centuries. We have tried to describe the milestones in this development and how each generation of scientists built on the heritage and foundations laid by their predecessors. Many historians dismiss the "great man theory," which alleges that giant "leaps of human knowledge are made by great thinkers who transcend the boundaries of their times; great scientists don't leap outside their time, but somewhere else in their own time" (Hevly, 1990). We found this to be the case in the history of statistics. Even the innovative writings of Karl Pearson and Sir Ronald Fisher that became the foundation of modern mathematical statistics were the outcome of two centuries of antecedent ideas and information.

A unique overview that melds the concepts of conditional probability and stochastic processes into real-life applications
The role of randomization techniques in clinical trials has become increasingly important. This comprehensive guide combines both the applied aspects of randomization in clinical trials with a probabilistic treatment of properties of randomization. Taking an unabashedly non-Bayesian and nonparametric approach to inference, the book focuses on the linear rank test under a randomization model, with added discussion on likelihood-based inference as it relates to sufficiency and ancillarity. Developments in stochastic processes and applied probability are also given where appropriate. Intuition is stressed over mathematics, but not without a clear development of the latter in the context of the former.

Clinical trials are experiments designed to evaluate new interventions to prevent or treat disease in humans. The interventions evaluated can be drugs, devices (e.g., hearing aid), surgeries, behavioral interventions (e.g., smoking cessation program), community health programs (e.g. cancer screening programs) or health delivery systems (e.g., special care units for hospital admissions). We consider clinical trials experiments because the investigators rather than the patients or their doctors select the treatment the patients receive. Results from randomized clinical trials are usually considered the highest level of evidence for determining whether a treatment is effective because trials incorporates features to ensure that evaluation of the benefits and risks of treatments are objective and unbiased. The FDA requires that drugs or biologics (e.g., vaccines) are shown to be effective in clinical trials before they can be sold in the US.