Guide to Clinical Interpretation of Data [antikvár]

Preface Over the last few decades there has been a trend to emphasize the role of statistics in the interpretation of investigational data. This has been appropriate and has helped advance the standards of clinical study design, conduct, and interpretation. Clinical interpretation of data, however, has often not received its rightful recognition and emphasis for the role it plays in data interpretation. There are numerous well-written monographs and articles on statistics, formal logic, and causality, but none that solely describes the clinical interpretation of data. A number of texts emphasize the concepts of both statistics and logic, usually related to the field of epidemiology (Süsser, 1973; Riegelman, 1981; Fletcher et al., 1982; Feinstein, 1985; Sackett et al., 1985). This book reemphasizes the essential role that clinical interpretation plays in data evaluation and considers various perspectives in viewing data. These include the perspective of the interpreter in a private medical practice, pharmaceutical corporation, academic environment, or government regulatory agency. These individuals focus attention on the type of data generated (e.g., safety, efficacy), the population evaluated (e.g., according to age, physiological function), and/or the modality evaluated (e.g., biofeedback, radiation therapy, surgery, hyperthermia). The importance of statistics in data analysis and as a basis for deriving an accurate cUnical interpretation is affirmed and stressed. There is a natural progression from the statistical to the clinical evaluation of data. Involvement of both disciplines is usually necessary to attain an adequate interpretation of the data. A coordination and an integration of the two approaches and disciplines are desirable. This volume was written as a sequel to Guide to Clinical Studies and Developing Protocols. That hook described the various processes involved in planning clinical studies, preparing protocols, and initiating, conducting, and terminating sUidies. This book describes various ways of approaching and interpreting the data that result from a clinical study. This volume is intended for individuals in medical practice, academic institutions, pharmaceutical corporations, hospitals, or government regulatory and administrative agencies who are involved in either the interpretation of clinical data or the evaluation of clinical interpretations. Physicians must often decide whether to prescribe a specific drug for a specific patient in a specific situation. Their decision is based largely on their interpretation of data they have read and heard. Individuals who read and evaluate documents with statistical concepts also must often evaluate clinical data and assessments. This book provides principles and tools to assist in these endeavors. This volume differs from others in that it describes and elaborates on the clinical approach to interpretation of data without relying on statistics or formal logic. There are five sections in this book. The first, "Fundamental Principles, Considerations, and Techniques," describes the processes used in the clinical interpre-