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Manual for the planning and implementation of therapeutic studies
238
Book reviews
independently from tests using clinical trials which are difficult to design and expensive to conduct. The use of computing to discover potentially viable but only partially substantiated hypotheses is intriguing. This is a book for those interested in medical records and their exploration and will certainly stimulate them to take up the challenge. J. ANDERSON
Manual for the Planning and Implementation of Therapeutic Studies, by S. Biefang, W. Kopcke and M.A. Schreiber. From the series entitled: Lekture Notes in Medical Informatics, edited by D.A.B. Lindberg and P.L. Reichertz, Springer-Verlag, Berlin
1982, 100 pp. ($11.40). This book is a survey of the methodology of clinical trials including their planning and termination. It also covers the use of information processing methods to improve the analysis of data and the results of such endeavours. The book begins with a review of the methods of therapeutic studies and briefly explains the terminology, types of studies and experimental design, including the steps that are usually taken in drug testing. It stresses the important role of study protocols and the use of documentation for collecting data. The importance of randomisation to control the unknown factors influencing the outcome is stressed. The requirements for prospective and non-randomised observational studies are outlined and discussed using examples. In relation to the planning, implementation and evaluation of such clinical therapeutic studies, the documentation and organisation is explored. There is emphasis placed on data collection which is important in that it has to be valid and reliable. Development of appropriate documentation in these circumstances can be difficult. The different ways of processing such data for appropriate analysis is explored briefly. Emphasis is given to the need to have a good organ&&ion to carry out such studies and to guide the analysis of data. The special problems that arise during the implementation of multi-centre therapeutic studies are briefly analysed and the methods used for quality control of data explored. Problems of patient recruitment and drop-out are indicated and also the difficulties that arise when deciding to terminate such therapeutic studies. Also of importance are the environmental conditions in which the therapeutic studies take place. Naturally there are, depending on the type of therapeutic study, ethical and legal considerations which deserve due attention. There are also problems in providing incentives for participation in such studies, not only by the research worker but also by patients. A brief section describes the simple measures that may be used to improve and promote the development of such therapeutic trials. It is
Book reviews
239
obvious, however, that these trials are expensive and that the bulk of medical data will still be collected by observational methods other than by comparative trials. This book is for those interested in learning the elementary facts about the planning and implementation of therapeutic studies. More detail would be required if they were going to go into the information side but it would be helpful to those starting in the field from the informatics or medical point of view. J. ANDERSON
Book reviews
independently from tests using clinical trials which are difficult to design and expensive to conduct. The use of computing to discover potentially viable but only partially substantiated hypotheses is intriguing. This is a book for those interested in medical records and their exploration and will certainly stimulate them to take up the challenge. J. ANDERSON
Manual for the Planning and Implementation of Therapeutic Studies, by S. Biefang, W. Kopcke and M.A. Schreiber. From the series entitled: Lekture Notes in Medical Informatics, edited by D.A.B. Lindberg and P.L. Reichertz, Springer-Verlag, Berlin
1982, 100 pp. ($11.40). This book is a survey of the methodology of clinical trials including their planning and termination. It also covers the use of information processing methods to improve the analysis of data and the results of such endeavours. The book begins with a review of the methods of therapeutic studies and briefly explains the terminology, types of studies and experimental design, including the steps that are usually taken in drug testing. It stresses the important role of study protocols and the use of documentation for collecting data. The importance of randomisation to control the unknown factors influencing the outcome is stressed. The requirements for prospective and non-randomised observational studies are outlined and discussed using examples. In relation to the planning, implementation and evaluation of such clinical therapeutic studies, the documentation and organisation is explored. There is emphasis placed on data collection which is important in that it has to be valid and reliable. Development of appropriate documentation in these circumstances can be difficult. The different ways of processing such data for appropriate analysis is explored briefly. Emphasis is given to the need to have a good organ&&ion to carry out such studies and to guide the analysis of data. The special problems that arise during the implementation of multi-centre therapeutic studies are briefly analysed and the methods used for quality control of data explored. Problems of patient recruitment and drop-out are indicated and also the difficulties that arise when deciding to terminate such therapeutic studies. Also of importance are the environmental conditions in which the therapeutic studies take place. Naturally there are, depending on the type of therapeutic study, ethical and legal considerations which deserve due attention. There are also problems in providing incentives for participation in such studies, not only by the research worker but also by patients. A brief section describes the simple measures that may be used to improve and promote the development of such therapeutic trials. It is
Book reviews
239
obvious, however, that these trials are expensive and that the bulk of medical data will still be collected by observational methods other than by comparative trials. This book is for those interested in learning the elementary facts about the planning and implementation of therapeutic studies. More detail would be required if they were going to go into the information side but it would be helpful to those starting in the field from the informatics or medical point of view. J. ANDERSON