Fundamentals of Clinical Trials [antikvár]

PrefaceThe clinical trial is "the most detinitive tool for evaluation of the applicability of clinical research." It represents "a key research activity with the potential to improve the quality of health care and control costs through careful comparison of alternative treatments.'""Wliile many reported clinical trials are of high quality, a careful reviewer of the medical literature will notice that a significant number have deficiencies in design, conduct, analysis, presentation, or interpretation of results. Although improvements have occurred in clinical studies,^ there is still considerable doubt that major progress has occurred.-^ " Certainly, many studies could have been upgraded if the authors had had a better understanding of the fundamentals. The U.S. Food and Drug Administration (FDA) has issued stricter guidelines for drug approval that are consistent with the principles expressed in this book."' Similar guidelines for the approval of devices have also been established by the FDA.Since the publication of the first (1981) and second (1985) editions of this book, several other texts on cUnical trials have appeared.* Few of them, however, discuss general as well as specific issues involved in the development, management, and analysis of clinical trials. The purpose of this third edition is to update areas in which considerable progress has recently been made, and to broaden the scope, in the light of clinical trials in new areas. All chapters have been updated; several have been substantially expanded or cover additional topics.In this book we hope to assist investigators in academia and industry in improving the quality of clinical trials by discussing fundamental concepts with examples from our experience and the literature. It is intended for investigators with some clinical trial experience as well as for those who plan to conduct a trial for the first time. It is also intended to be used as a textbook in the teaching of clinical trial methodology and to assist members of the scientific and medical community who wish to evaluate and interpret published reports of trials. Although not a technically oriented text, it may be used as a reference for a graduate course on statistical methods in clinical trials.The first half of the book concerns design and development phases of a trial. These chapters are relevant for all investigators. Chapter 9 reviews recruitment techniques and may be of special interest to investigators not having ready access to participants. Methods for collecting high quality data and some common problems in data collection are included in Chapter 10. Chapters 11 and 12 focus on the important areas of assessment of adverse effects and quality of life. Measures to enhance and monitor participant adherence are presented in Chapter 13. ChapterReferences: 1, 5, 6, 8, 9, 10, 12, 14, 15, 16, 17.vii