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In 1998, R. Smith wrote that “The randomized clinical trial is the most important advance in scientific medicine in the twentieth century.” Smith’s view may surprise some of our clinical colleagues but is entirely defensible. Sequences of randomized trials have led to dramatic advances in chronic diseases such as breast cancer, childhood leukemia, HIV, cardiovascular disease, and many other areas. These and other diseases are biologically complex and, despite decades of research, still understood incompletely, at best. Adequately powered trials have led to the discovery of incremental advances that have cumulatively yielded substantial improvements in survival and disease control.
The contributions to this volume examine some issues in clinical trial design that have received attention in recent years. The collection is intended primarily for the statistical practitioner, especially the very busy trialist whose active collaboration in cancer, HIV, cardiology, or other areas of medical research makes it difficult to find the time to stay abreast of advances in trial methodology. The contributors and I share the opinion that while the large majority of trials are well-designed and conducted, newer methods for design and analysis linger too long in the methodology literature before appearing in mainstream use.
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