- Email: [email protected]
Presentation of clinical data
TIBTECH- DECEMBER 1990 [Vol. 8]
363
A measure of microbial metabolism BIOTECHNOLOGY
-- A TEXTBOOK OF
INDUSTRIAL MICROBIOLOGY,
2ND EDN
by Wulf Crueger and Anneliese Crueger, Sinauer Associates, 1990. £35.95 (357 pages) ISBN O87893 131 7 This is the second edition of a good and well-used university text on industrial microbiology. The book has been translated directly from German and the translator is to be highly commended since it is very readable and there are remarkably few spelling mistakes. Many biotechnology books attempt to cover a wide area of the subject, with the inevitable consequence of either not being comprehensive or lacking in enough detail to be useful. However, this book is more targetted, focusing on the products of microbial metabolism, whether produced during fermentation or biotransformation. There is a detailed, but very clear, introduction to genetics, which has been considerably updated since the first edition, to include the use of recombinant DNA (rDNA) technology for strain selection and the production of pharmaceutical proteins. Perhaps slightly surprising for German authors, there is no discussion of the regulatory issues currently surrounding the implementation of rDNA technology. The chapters which follow, on fermentation, are first class with well laid out diagrams and illustrative examples throughout. However, this thoroughness is not followed through, and a distinct weakness of the book is the chapter on product recovery. Many industrial biotechnological processes fail because of the difficulties of downstream p~ocessing and recovering products from the microorganism. In my view a longer and more detailed section could easily have been justified on this important topic, especially since the interaction of the upstream fermentation with product recovery is now well established. The majority of the rest of the book is devoted to discussion of the manufacture of a whole series of microbial products: ethanol and or-
ganic feedstocks, organic acids, amino acids, nucleosides and related compounds, enzymes, vitamins, antibiotics, ergot alkaloids, and single cell proteins. Throughout much of the book the emphasis is on products and the enormous potential of microbial production systems. Much more could have been made of the processes and the technology required to bring these products to the market. Three chapters do make amends to this with discussion of microbial biotransformations, []
[]
[]
[]
sewage treatment and microbial leaching. Two general criticisms of the book are the lack of up-to-date references, especially for a second edition, and the absence of discussion about recent control developments and computer-aided fermentation. However, the overall impression is of an excellently laid out book, ideal for fermentation teaching at undergraduate and postgraduate levels. Consequently, it is a little disappointing that in hardback the book is out of the reach of most student pockets. J. M . W O O D L E Y
SERC Centre for Biochemical Engineering, Department of Chemical and Biochemical Engineering, University College London, Torrington Place, London WCIE 7JE, UK. []
[]
[]
[]
What to do with data PRESENTATION
OF CLINICAL DATA
by B. Spilker and J. Schoenfelder, Raven Press, 1990. US$100.00 (553 pages) ISBN 0 881 67566 0 To present voluminous and complex clinical data in a clear and concise way is often difficult even for specialists in the field. This book not only gives a useful introduction but also provides more detailed information for the initiated on specific topics. Much of the book comprises examples of different types of data display, with comprehensive legends, augmented by brief notes, suggesting alternative methods of display and identifying significant features of each technique. Many examples are taken from the literature cited in the comprehensive bibliography. When discussing the ways of using different types of presentation, the data formats are dealt with in a logical sequence: tables, then graphs and finally figures. The book is enhanced by a useful index. Chapter 1 introduces types of tables and figures available for data presentation. Many examples are illustrated and it is likely even those experienced in this field will find some new ideas from this section. The types and methods of display for lecture presentations are addressed
in a brief second chapter. This is a deviation from the main thrust of the book and is adequately covered in many other texts. However, it does no harm to remind potential speakers that people sitting at the back of a lecture theatre cannot read a full page of standard typed A4 paper, when enlarged and projected on to a screen. Ways of illustrating study designs are described in Chapter 3. Many diagrams are used to describe forms of study design, including: (1) the overall study form (e.g. parallel or crossover, single entity or combination study), (2) treatment groups within a study, (3) periods of a study (e.g. screening, baseline, treatment and follow-up), (4) sections of a study (e.g. open label section, blinded section), (5) duration of each study period, (6) type of blinding used in each period of the study, (7) dosing schedule used in each period of the study, and (8) critical time points (e.g. times of treatment, retreatment and efficacy evaluation). The next eight chapters deal with certain categories of patient data. The title of Chapter 4, 'Demographics and patient accountability', does not reveal its contents. As well as covering patients' basic statistics (including height, weight, age and sex), it also includes prior therapy. This
364
information is often crucial to the interpretation of a study. 'Patient accountability' refers to the number of patients in each section of a study (e.g. of a total of 100 patients interviewed, only 85 may be screened, only 80 of these may be entered onto the study, and only 50 of those entered may be evaluable). Such a breakdown provides a useful and reassuring check on the total number of subjects presented in later analyses and is an important component of any clinical registration package submitted to a regulatory authority for a product licence. 'Vital signs' and 'Laboratory data' receive attention with an emphasis on displaying what is clinically relevant from a large body of data. For example, layouts are illustrated which show baseline and treatmentperiod vital signs adjacent to each other, together with the difference between them. The importance of describing changes in values and relating these to critical _time points in the study is emphasized. Examples show how values can be given as a percentage of the baseline rather than in the original units. A significant amount of space is devoted to illustrating data from electrocardiograms, which is perhaps of limited appeal. There are usually more laboratory data than other types of data in a study. The authors suggest several ways of summarizing important data (e.g. showing only those values which are clinically significant, or only those which lie outside a specified range). Interestingly, the authors also suggest standardizing data from multiple sites to a scale from 0 to 100 (where 0 represents the lower limit of a specified range and 100 the upper limit). A nice idea this, but clinicians, who are used to seeing certain tests always displayed in the same units, may find it hard to accept. The chapter on adverse drug reactions (ADRs) suggests many ways of expressing the incidence of these in a population. Much ADR and laboratory data relates to the severity of an event. However, the authors do not point out that the amount of data displayed can be reduced by selecting (for each group of observations and for each event) the maximum severity or maximum 'treatment relatedness'. Efficacy varies greatly between studies and consequently,
TIBTECH - D E C E M B E R 1990 [Vol. 8]
the chapter discussing this (Chapter 8) is the longest one in the book and covers many different types of clinical investigation. Three short chapters follow which cover ptiarmacokinetic data, quality of life and (in a rather mixed Chapter 11) patient compliance, concomitant therapy and the cost benefits of treatment. These do not contribute much to the book, unlike Chapter 12 on meta-analyses, where the guidelines for selecting data from different studies for the analysis are outlined. Examples are given where data are displayed separately for each study on a particular topic, and where the data from different studies are pooled. The book finishes off with a chapter on complex or confusing []
[]
[]
[]
presentations. Here the authors show how not to display data and suggest simple and clear ways of illustrating the same information. Overall, Spilker and Schoenfelder's book provides a useful introduction to the field of clinical data display, as well as a reference for those already familiar with the area. I know several experienced people who could benefit from consulting its pages at the beginning of a study program. RICHARD M A T H E R
Cyanamid (GB) Ltd, Cyanamid International Research Centre, Shearwater House, 21 The Green, Richmond, Surrey TW9 1PJ, UK. []
[]
[]
[]
Not enough bread and beer B I O T E C H N O L O G Y IN THE FOOD INDUSTRY
edited by M. P. Tombs, Open University Press, 1990. £14.99 (ix + 189 pages) ISBN 0 335 15898 6 This book is the tenth title in The Biotechnology Series. Although more books on the same subject have appeared recently (e.g. Food Biotechnology, R. Angold, G. Beech and J. Taggart, eds, Cambridge University Press, 1989) this book is enjoyable because food biotechnology is approached from the industrial standpoint. This aspect is put forward in Chapter I, which, besides providing a general introduction to the biochemical principles of biotechnology, gives an overview of the time-scale and economics for the entry of a novel enzyme into industrial production. A number of industrial applications of biotechnology are described in the following four chapters. Although it is impossible to cover the total field mentioned in the title, I have the impression that most facets of the interdisciplinary subject of biotechnology are touched upon. Besides the success story of artificial sweeteners, the (possible) use of enzymes in modification of structure-building components of food is described. More recent developments in biotechnology are also mentioned (e.g. genetic and protein engineering) and the use of plant-
cell cultures. The last chapter is concerned with hazards associated with foodstuffs and the part which biotechnology might play in reducing them. My only real criticism of the book is that there is no balance in the amount of detail given for the various subjects. Protein gelation and stability are described in much detail, while the biotechnologica] possibilities of cereals in baking and brewing, for example, are mentioned only superficially. Being an 'insider' on this subject, I missed a more detailed description of the role which (biotechnologically produced and/or adapted) yeasts and enzymes (may) play in the world's most important foodstuffs (bread and beer). In the description of some other subjects, the industrial standpoint is completely overruled by scientific dreaming. However, the author states 'this book is intended as an introductory text for third-year undergraduates and people engaged in research and development in the food industry', and I would indeed recommerid this book to those groups, because it will serve as a good introduction to the potential use of biotechnology. Suggestions for further reading are given at the end of the book. JAN D. R. HILLE
Gist-brocades NV, PO Box 1, 2600 MA Delft, The Netherlands.
363
A measure of microbial metabolism BIOTECHNOLOGY
-- A TEXTBOOK OF
INDUSTRIAL MICROBIOLOGY,
2ND EDN
by Wulf Crueger and Anneliese Crueger, Sinauer Associates, 1990. £35.95 (357 pages) ISBN O87893 131 7 This is the second edition of a good and well-used university text on industrial microbiology. The book has been translated directly from German and the translator is to be highly commended since it is very readable and there are remarkably few spelling mistakes. Many biotechnology books attempt to cover a wide area of the subject, with the inevitable consequence of either not being comprehensive or lacking in enough detail to be useful. However, this book is more targetted, focusing on the products of microbial metabolism, whether produced during fermentation or biotransformation. There is a detailed, but very clear, introduction to genetics, which has been considerably updated since the first edition, to include the use of recombinant DNA (rDNA) technology for strain selection and the production of pharmaceutical proteins. Perhaps slightly surprising for German authors, there is no discussion of the regulatory issues currently surrounding the implementation of rDNA technology. The chapters which follow, on fermentation, are first class with well laid out diagrams and illustrative examples throughout. However, this thoroughness is not followed through, and a distinct weakness of the book is the chapter on product recovery. Many industrial biotechnological processes fail because of the difficulties of downstream p~ocessing and recovering products from the microorganism. In my view a longer and more detailed section could easily have been justified on this important topic, especially since the interaction of the upstream fermentation with product recovery is now well established. The majority of the rest of the book is devoted to discussion of the manufacture of a whole series of microbial products: ethanol and or-
ganic feedstocks, organic acids, amino acids, nucleosides and related compounds, enzymes, vitamins, antibiotics, ergot alkaloids, and single cell proteins. Throughout much of the book the emphasis is on products and the enormous potential of microbial production systems. Much more could have been made of the processes and the technology required to bring these products to the market. Three chapters do make amends to this with discussion of microbial biotransformations, []
[]
[]
[]
sewage treatment and microbial leaching. Two general criticisms of the book are the lack of up-to-date references, especially for a second edition, and the absence of discussion about recent control developments and computer-aided fermentation. However, the overall impression is of an excellently laid out book, ideal for fermentation teaching at undergraduate and postgraduate levels. Consequently, it is a little disappointing that in hardback the book is out of the reach of most student pockets. J. M . W O O D L E Y
SERC Centre for Biochemical Engineering, Department of Chemical and Biochemical Engineering, University College London, Torrington Place, London WCIE 7JE, UK. []
[]
[]
[]
What to do with data PRESENTATION
OF CLINICAL DATA
by B. Spilker and J. Schoenfelder, Raven Press, 1990. US$100.00 (553 pages) ISBN 0 881 67566 0 To present voluminous and complex clinical data in a clear and concise way is often difficult even for specialists in the field. This book not only gives a useful introduction but also provides more detailed information for the initiated on specific topics. Much of the book comprises examples of different types of data display, with comprehensive legends, augmented by brief notes, suggesting alternative methods of display and identifying significant features of each technique. Many examples are taken from the literature cited in the comprehensive bibliography. When discussing the ways of using different types of presentation, the data formats are dealt with in a logical sequence: tables, then graphs and finally figures. The book is enhanced by a useful index. Chapter 1 introduces types of tables and figures available for data presentation. Many examples are illustrated and it is likely even those experienced in this field will find some new ideas from this section. The types and methods of display for lecture presentations are addressed
in a brief second chapter. This is a deviation from the main thrust of the book and is adequately covered in many other texts. However, it does no harm to remind potential speakers that people sitting at the back of a lecture theatre cannot read a full page of standard typed A4 paper, when enlarged and projected on to a screen. Ways of illustrating study designs are described in Chapter 3. Many diagrams are used to describe forms of study design, including: (1) the overall study form (e.g. parallel or crossover, single entity or combination study), (2) treatment groups within a study, (3) periods of a study (e.g. screening, baseline, treatment and follow-up), (4) sections of a study (e.g. open label section, blinded section), (5) duration of each study period, (6) type of blinding used in each period of the study, (7) dosing schedule used in each period of the study, and (8) critical time points (e.g. times of treatment, retreatment and efficacy evaluation). The next eight chapters deal with certain categories of patient data. The title of Chapter 4, 'Demographics and patient accountability', does not reveal its contents. As well as covering patients' basic statistics (including height, weight, age and sex), it also includes prior therapy. This
364
information is often crucial to the interpretation of a study. 'Patient accountability' refers to the number of patients in each section of a study (e.g. of a total of 100 patients interviewed, only 85 may be screened, only 80 of these may be entered onto the study, and only 50 of those entered may be evaluable). Such a breakdown provides a useful and reassuring check on the total number of subjects presented in later analyses and is an important component of any clinical registration package submitted to a regulatory authority for a product licence. 'Vital signs' and 'Laboratory data' receive attention with an emphasis on displaying what is clinically relevant from a large body of data. For example, layouts are illustrated which show baseline and treatmentperiod vital signs adjacent to each other, together with the difference between them. The importance of describing changes in values and relating these to critical _time points in the study is emphasized. Examples show how values can be given as a percentage of the baseline rather than in the original units. A significant amount of space is devoted to illustrating data from electrocardiograms, which is perhaps of limited appeal. There are usually more laboratory data than other types of data in a study. The authors suggest several ways of summarizing important data (e.g. showing only those values which are clinically significant, or only those which lie outside a specified range). Interestingly, the authors also suggest standardizing data from multiple sites to a scale from 0 to 100 (where 0 represents the lower limit of a specified range and 100 the upper limit). A nice idea this, but clinicians, who are used to seeing certain tests always displayed in the same units, may find it hard to accept. The chapter on adverse drug reactions (ADRs) suggests many ways of expressing the incidence of these in a population. Much ADR and laboratory data relates to the severity of an event. However, the authors do not point out that the amount of data displayed can be reduced by selecting (for each group of observations and for each event) the maximum severity or maximum 'treatment relatedness'. Efficacy varies greatly between studies and consequently,
TIBTECH - D E C E M B E R 1990 [Vol. 8]
the chapter discussing this (Chapter 8) is the longest one in the book and covers many different types of clinical investigation. Three short chapters follow which cover ptiarmacokinetic data, quality of life and (in a rather mixed Chapter 11) patient compliance, concomitant therapy and the cost benefits of treatment. These do not contribute much to the book, unlike Chapter 12 on meta-analyses, where the guidelines for selecting data from different studies for the analysis are outlined. Examples are given where data are displayed separately for each study on a particular topic, and where the data from different studies are pooled. The book finishes off with a chapter on complex or confusing []
[]
[]
[]
presentations. Here the authors show how not to display data and suggest simple and clear ways of illustrating the same information. Overall, Spilker and Schoenfelder's book provides a useful introduction to the field of clinical data display, as well as a reference for those already familiar with the area. I know several experienced people who could benefit from consulting its pages at the beginning of a study program. RICHARD M A T H E R
Cyanamid (GB) Ltd, Cyanamid International Research Centre, Shearwater House, 21 The Green, Richmond, Surrey TW9 1PJ, UK. []
[]
[]
[]
Not enough bread and beer B I O T E C H N O L O G Y IN THE FOOD INDUSTRY
edited by M. P. Tombs, Open University Press, 1990. £14.99 (ix + 189 pages) ISBN 0 335 15898 6 This book is the tenth title in The Biotechnology Series. Although more books on the same subject have appeared recently (e.g. Food Biotechnology, R. Angold, G. Beech and J. Taggart, eds, Cambridge University Press, 1989) this book is enjoyable because food biotechnology is approached from the industrial standpoint. This aspect is put forward in Chapter I, which, besides providing a general introduction to the biochemical principles of biotechnology, gives an overview of the time-scale and economics for the entry of a novel enzyme into industrial production. A number of industrial applications of biotechnology are described in the following four chapters. Although it is impossible to cover the total field mentioned in the title, I have the impression that most facets of the interdisciplinary subject of biotechnology are touched upon. Besides the success story of artificial sweeteners, the (possible) use of enzymes in modification of structure-building components of food is described. More recent developments in biotechnology are also mentioned (e.g. genetic and protein engineering) and the use of plant-
cell cultures. The last chapter is concerned with hazards associated with foodstuffs and the part which biotechnology might play in reducing them. My only real criticism of the book is that there is no balance in the amount of detail given for the various subjects. Protein gelation and stability are described in much detail, while the biotechnologica] possibilities of cereals in baking and brewing, for example, are mentioned only superficially. Being an 'insider' on this subject, I missed a more detailed description of the role which (biotechnologically produced and/or adapted) yeasts and enzymes (may) play in the world's most important foodstuffs (bread and beer). In the description of some other subjects, the industrial standpoint is completely overruled by scientific dreaming. However, the author states 'this book is intended as an introductory text for third-year undergraduates and people engaged in research and development in the food industry', and I would indeed recommerid this book to those groups, because it will serve as a good introduction to the potential use of biotechnology. Suggestions for further reading are given at the end of the book. JAN D. R. HILLE
Gist-brocades NV, PO Box 1, 2600 MA Delft, The Netherlands.