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Clinical research in pharmaceutical development
Book Reviews
461
but they provide an interesting comparison with randomized trials. They describe the difficulties of interpreting observational studies and concentrate on the types of biases that can occur. It is a pity that the book contained no chapter on the role of overviews as a way of combining the results of many trials. Also, it is a pity that the book, although peppered with examples of different trials, did not mention more problems with individual trials, because problems are sometimes more informative than successes. These omissions are, however, minor and distract little from the book as a whole. The book provides a much needed authoritative account of many of the issues in AIDS clinical trials, and should prove useful to both clinicians and trialists. Tim EA Pete Abdel G Babiker Janet H Darbyshire MRC HIV Clinical Trials Centre University College London Medical School London, United Kingdom PII SO197-2456(96)00239-5 Clinical Research in Pharmaceutical Development edited by Barry Bleidt and Michael Montagne, Marcel Dekker, Inc., New York, 1996, 368 pages, ISBN: o-8247-9745-0, $135, hard cover. This is the 75th volume in a series entitled Drugs and the Pharmaceutical Sciences (James Swarbrick, Executive Editor, Marcel Dekker, Inc., New York). In this book, Bleidt and Montagne introduce the reader to (a) the growth of drug development and clinical research and (b) guidelines for organizing and performing research activities in the process of drug development and registration. The book is divided into five parts. Each chapter begins with a table of contents, allowing the reader to determine its scope quickly. In Part I, Chapter 1, Bleidt and Montagne review each of the remaining chapters in the book. The chapter ends with a table of citations of federal regulations applicable to clinical research. Chapter 2 briefly reviews the process of new product development at the molecular level. Part II consists entirely of one chapter written by A. Hofmann, who gives an account of his own laboratory experiences as a scientist involved in new drug discovery. Although Parts I and II are interesting, the theme of the book becomes much more evident beginning with the next section. Part III reviews the drug development process. Chapter 4 describes milestone events attributed to the development of clinical research methods, the evolution of clinical research in drug development and the emergence of federal regulatory involvement. This chapter is informative for its overview of the origins and growth of pharmaceutical research and of the expanding influence of today’s Food and Drug Administration. This chapter also exposes the reader to two themes that recur throughout the remainder of the book: informed consent and regulatory control in the drug development process. Chapter 5, which introduces the stages of pharmaceutical development, including brief descriptions of preclinical testing, clinical testing, and postmarketing surveillance, is a useful primer on the drug-approval process in the United States and
462
Book Reviews
the benchmark stages of FDA approval. In understandable terms, it describes each of the four phases of clinical testing in humans and provides schematics of the regulated drug development and approval process. Chapter 6 builds upon Chapter 5 by describing the regulatory stages through which drug development and registration must navigate. The descriptions of IND preparation, clinical protocol development and execution, human subject protection, and informed consent are relevant to the planning of clinical research. An overview of the roles and responsibilities of sponsors and investigators and of what to expect during an FDA audit is also informative. This chapter would be most helpful to anyone newly responsible for performing clinical trials. It introduces applicable terms and definitions and gives a step-by-step overview of the documentation required of both sponsor and investigator for conducting studies in compliance with Good Clinical Practice guidelines. Part IV introduces fundamental principles of clinical research. Chapter 7 introduces concepts related to pharmacokinetics and pharmacodynamic assessment. Chapter 8 reviews the coordination and monitoring of clinical trials. This chapter provides a helpful summary of key steps to successful management of drug trials. Chapter 9, which builds upon the concepts introduced in Chapter 8, includes a detailed outline of the organization and content of a study protocol. While Chapters 8 and 9 do not provide details about the logistics of study management, they present a quick review of the basics for planning a study. Chapter 10 introduces outcomes research and its rapidly emerging importance in clinical research and drug development. To the novice, this chapter provides a concise review of the terminology, approaches, and application of health outcomes in evaluating drug usefulness. Chapter 11 describes pharmacoeconomics and quality-of-life evaluations and their roles in the drug development process. It builds upon the cost analysis methodologies introduced in Chapter 10 and provides examples for measuring outcomes and indices of quality of life. Chapters 10 and 11 introduce the concept that social issues affect drug development. This theme carries through into the next and final part of the book. Part V presents social and legal aspects of pharmaceutical development, Chapter 12 introduces the issues of pharmaceutical marketing and its involvement in the drug development process from its earliest stages. Whether or not one agrees with the content, this chapter does make the reader aware that marketing cannot be ignored. Chapter 13, which explores ethical issues in clinical therapeutics research, reminds the reader of the requirements for protection of human subjects and informed consent. It discusses the roles and duties of sponsor, scientist, clinical investigator, and patient as well as research and ethical issues concerning the use of placebos, recruitment of subjects, and clinical testing in special populations. A section on ethical principles is written in a manner that is informative for all those who have not trained in law or ethics. Chapter 14 reviews legal issues affecting drug development in the United conflict of interest, clinical trial States, including advertising restrictions, agreements, reporting requirements, misconduct, and government inspections. The final chapter of Part V, which covers the topic of social aspects in pharmaceutical development, presents an interesting overview of pharamacoepidemiology and the application of social factors in predicting drug behaviors from both medical and nonmedical perspectives.
Book Reviews
463
This book would be useful for those new to pharmaceutical and clinical research who wish to obtain an overview of the drug development process in the United States. It introduces the reader to the regulatory, legal, and ethical issues of clinical research in the drug development process. The chapters that review federal regulations and guidelines for organizing clinical trials are informative. There are a few redundancies across some chapters, and once or twice the objectives of the book are lost. Although the cost is rather high for a personal collection, this book is a candidate for institutional and departmental libraries. Rita M. Pelusio, MSEd NAD Research & Development Johnson & Johnson Clinical Diagnostics Rochester, New York PI1 SO197-2456(97)00077-9
461
but they provide an interesting comparison with randomized trials. They describe the difficulties of interpreting observational studies and concentrate on the types of biases that can occur. It is a pity that the book contained no chapter on the role of overviews as a way of combining the results of many trials. Also, it is a pity that the book, although peppered with examples of different trials, did not mention more problems with individual trials, because problems are sometimes more informative than successes. These omissions are, however, minor and distract little from the book as a whole. The book provides a much needed authoritative account of many of the issues in AIDS clinical trials, and should prove useful to both clinicians and trialists. Tim EA Pete Abdel G Babiker Janet H Darbyshire MRC HIV Clinical Trials Centre University College London Medical School London, United Kingdom PII SO197-2456(96)00239-5 Clinical Research in Pharmaceutical Development edited by Barry Bleidt and Michael Montagne, Marcel Dekker, Inc., New York, 1996, 368 pages, ISBN: o-8247-9745-0, $135, hard cover. This is the 75th volume in a series entitled Drugs and the Pharmaceutical Sciences (James Swarbrick, Executive Editor, Marcel Dekker, Inc., New York). In this book, Bleidt and Montagne introduce the reader to (a) the growth of drug development and clinical research and (b) guidelines for organizing and performing research activities in the process of drug development and registration. The book is divided into five parts. Each chapter begins with a table of contents, allowing the reader to determine its scope quickly. In Part I, Chapter 1, Bleidt and Montagne review each of the remaining chapters in the book. The chapter ends with a table of citations of federal regulations applicable to clinical research. Chapter 2 briefly reviews the process of new product development at the molecular level. Part II consists entirely of one chapter written by A. Hofmann, who gives an account of his own laboratory experiences as a scientist involved in new drug discovery. Although Parts I and II are interesting, the theme of the book becomes much more evident beginning with the next section. Part III reviews the drug development process. Chapter 4 describes milestone events attributed to the development of clinical research methods, the evolution of clinical research in drug development and the emergence of federal regulatory involvement. This chapter is informative for its overview of the origins and growth of pharmaceutical research and of the expanding influence of today’s Food and Drug Administration. This chapter also exposes the reader to two themes that recur throughout the remainder of the book: informed consent and regulatory control in the drug development process. Chapter 5, which introduces the stages of pharmaceutical development, including brief descriptions of preclinical testing, clinical testing, and postmarketing surveillance, is a useful primer on the drug-approval process in the United States and
462
Book Reviews
the benchmark stages of FDA approval. In understandable terms, it describes each of the four phases of clinical testing in humans and provides schematics of the regulated drug development and approval process. Chapter 6 builds upon Chapter 5 by describing the regulatory stages through which drug development and registration must navigate. The descriptions of IND preparation, clinical protocol development and execution, human subject protection, and informed consent are relevant to the planning of clinical research. An overview of the roles and responsibilities of sponsors and investigators and of what to expect during an FDA audit is also informative. This chapter would be most helpful to anyone newly responsible for performing clinical trials. It introduces applicable terms and definitions and gives a step-by-step overview of the documentation required of both sponsor and investigator for conducting studies in compliance with Good Clinical Practice guidelines. Part IV introduces fundamental principles of clinical research. Chapter 7 introduces concepts related to pharmacokinetics and pharmacodynamic assessment. Chapter 8 reviews the coordination and monitoring of clinical trials. This chapter provides a helpful summary of key steps to successful management of drug trials. Chapter 9, which builds upon the concepts introduced in Chapter 8, includes a detailed outline of the organization and content of a study protocol. While Chapters 8 and 9 do not provide details about the logistics of study management, they present a quick review of the basics for planning a study. Chapter 10 introduces outcomes research and its rapidly emerging importance in clinical research and drug development. To the novice, this chapter provides a concise review of the terminology, approaches, and application of health outcomes in evaluating drug usefulness. Chapter 11 describes pharmacoeconomics and quality-of-life evaluations and their roles in the drug development process. It builds upon the cost analysis methodologies introduced in Chapter 10 and provides examples for measuring outcomes and indices of quality of life. Chapters 10 and 11 introduce the concept that social issues affect drug development. This theme carries through into the next and final part of the book. Part V presents social and legal aspects of pharmaceutical development, Chapter 12 introduces the issues of pharmaceutical marketing and its involvement in the drug development process from its earliest stages. Whether or not one agrees with the content, this chapter does make the reader aware that marketing cannot be ignored. Chapter 13, which explores ethical issues in clinical therapeutics research, reminds the reader of the requirements for protection of human subjects and informed consent. It discusses the roles and duties of sponsor, scientist, clinical investigator, and patient as well as research and ethical issues concerning the use of placebos, recruitment of subjects, and clinical testing in special populations. A section on ethical principles is written in a manner that is informative for all those who have not trained in law or ethics. Chapter 14 reviews legal issues affecting drug development in the United conflict of interest, clinical trial States, including advertising restrictions, agreements, reporting requirements, misconduct, and government inspections. The final chapter of Part V, which covers the topic of social aspects in pharmaceutical development, presents an interesting overview of pharamacoepidemiology and the application of social factors in predicting drug behaviors from both medical and nonmedical perspectives.
Book Reviews
463
This book would be useful for those new to pharmaceutical and clinical research who wish to obtain an overview of the drug development process in the United States. It introduces the reader to the regulatory, legal, and ethical issues of clinical research in the drug development process. The chapters that review federal regulations and guidelines for organizing clinical trials are informative. There are a few redundancies across some chapters, and once or twice the objectives of the book are lost. Although the cost is rather high for a personal collection, this book is a candidate for institutional and departmental libraries. Rita M. Pelusio, MSEd NAD Research & Development Johnson & Johnson Clinical Diagnostics Rochester, New York PI1 SO197-2456(97)00077-9