Book reviews
Biophysics Problems: A Textbook with Answers P. Maróti, L. Berkes and F. Tölgyesi, Akadémiai Kiadó, Budapest, 1998, ISBN 963-05-7526-4, 495 pages, US$ 75. This book is part of a growing series of educational works which are essential texts for the professional education of biophysicists and biomedical engineers at both the undergraduate and postgraduate level. Senior scientists who need to know how physical methods and principles can be used to help their work, will also find this book extremely useful. The authors are faculty members of the Semmelweis Medical University in Budapest and the Jozsef Attila University in Szeged, Hungary (http://www.jate.u-szeged.hu/).The problems and their discussions profited greatly from the decades-long teaching experiences of the authors. More than 250 current problems from modern biophysics and related fields of application, together with detailed solutions are presented. The book is divided into 11 chapters and the topics follow the sequence of dimensions and diversity of the living world. It starts with the basic principles relating to the energetics of the living world (bioenergetics), and moves on to problems from the microworld (biophysics of molecules and biomembranes) and the macroworld (biomechanics, biophysics of organs, radiation and the environment). The subsequent chapters are devoted to problems concerning the application of different experimental methods in biology and in medicine (diagnostic and therapeutic methods and medical imaging). The problems in biostatistics help the reader to understand and to digest the concepts and the methods of evaluation of experimental data. The book is written for undergraduate and graduate students, with a view to improving their problem-solving ability. The reader is faced with the great challenge of finding solutions to the problems, but at the same time his or her knowledge of important concepts and relations is reinforced. The treatment of the problems is straightforward and well-documented, and their digestion does not usually demand any special background knowledge. The solutions provide full discussions of the problems and are well separated from the problems themselves. As the level of difficulty of the problems covers a wide range, both beginners and advanced readers will find pleasure in the book. In summary, Biophysics Problems is a highly topical, timely and well illustrated textbook which contains a wealth of practical problems with solutions associated with broad range of topics in biophysics. It will become an invaluable text for medical and pharmaceutical students interested in the application of physical principles to problems in biology and medicine. Biomedical engineers and physicists apply quantitative and integrative way of thinking about problems in biology, medical research and population dynamics and use wide spectrum of physical methods in their practice. This book is highly recommended to those studying and working in the above fields. Nándor Richter Email: nrichter@orki.hu Clinical Evaluation of Medical, Principles and Case Studies Karen Becker Witkin (Ed.), Humana Press, Totowa, New Jeresey, 1997, ISBN 0-896-03446-1, 256 pages, US$ 124.50 This book is primarily targeted at device companies. It is aimed at giving advice on standards for clinical trials with the aim of meeting regulations and providing a more efficient product development. The book is divided into two parts, the first one covering fundamentals of clinical study design and evaluation and the second part describing eight case studies. The first part gives an introduction to principles of clinical trials for development and marketing of medical devices. It gives a thorough discussion of differences between drugs and devices of importance for trials design, and gives an informative proposal to investigational plans for device trials. The authors describe in some detail the two main categories of investigation, viz. analytical (experimental) and observational (non-experimental). For some reason, they have found it worthwhile to devote a separate chapter to the latter category. The field of outcome measures (end points) for clinical studies of medical devices is shortly summarised. A list of recent studies is given, also describing types of outcome measures chosen in each study. The list shows that the endpoints often used are either performance measures or intermediary measures (surrogate end points), which do not give the ultimate global outcome in terms of clinical status and quality of life. The authors suggest that, in several cases, such measures would be informative with a great potential as additional measures. The last part of the general introduction describes regulatory requirements for clinical trials. It is much related to the US market and regulations by the Food and Drug Administration (FDA), although a section is devoted to studies conducted outside the US. A section is devoted to European standards for device clinical trials, however without mentioning the EU device directives. The case studies section deals with prosthetic heart valves, orthopaedics and total hip arthroplasty, collagen-based medical devices, in vitro diagnostic devices, a trial on a substance which is injected intra-articularly in osteo-arthritis of the knee and which is classified as a device by FDA, a study on device retrieval in substitute heart valves, and a study on pacemaker leads. This text definitely fills a need for a description of principles and approaches to clinical trials of medical devices. The elucidation of differences between drugs and devices with regard to the design of trials, including decisions on appropriate outcome measures, is an excellent summary and covers the important issues well, in my opinion. The outlined suggestion of an investigational plan, which may serve as a checklist for those planning and performing these studies, is indeed helpful. As an introduction to the field, I find it valuable that the basic issues of research designs, experimental and non-experimental, as well as the vast field of outcome measures are summarised in this manner. However, I find the approach a little limited outside the US due to the strong connection to this market. The choice of outcome measures are proposed with the needs of the companies in this market in mind. The focus is on living up to the existing regulations more than on the societal perspectives. It would have been valuable to, in addition, introduce the societal view on the micro, meso and macro levels in a publicly financed health system. Thereby, the perspectives of healthcare planners and policy makers could be dealt with. This perspective addresses implementation, adoption and diffusion of new devices into the healthcare system and the issues of setting priorities between alternatives on the clinical level, for clinical guidelines, as well as on a higher level, meaning comparisons between various areas of healthcare. This kind of reasoning is most relevant in publicaly financed healthcare systems and will increasingly have an impact on the medical device market. A detail in the book is that the sections on global outcomes are a bit obsolete and the list of references do not include recent achievements in this field. Intensive research in the area has provided developments and experiences of several global measures of health-related type quality of life and utility measures. One can foresee that companies in the development and marketing of new products will meet a better educated buyer in the future, with increased concern of effectiveness issues, taking the patients' ultimate health state and quality of life into consideration. The detailed case studies in the book illustrate well various study designs which have been applied to therapeutic as well as diagnostic products. In general these reports give useful general viewpoints on planning clinical trials. The reader should be aware that theses are basically related to FDA and of minor interest to other markets. Also, the registers and surveys mentioned are without exception from the US, this in spite of the fact that some internationally recognised high quality registers are held in Europe and Scandinavia, and are used by researchers as well as companies globally. A critical analysis of the principles for data recording and sources of errors is unfortunately not included in the text. To summarise, the book is an important contribution tot he field of evaluation of medical devices. It is well written and well structured and contains informative comparisons between the evaluation of drugs and the evaluation of medical devices. It is primarily targeted at companies who have the US market in focus. It lacks the perspective of publicly financed healthcare systems and the way these systems work in adopting and implementing new technologies. It also lacks updated contributions in outcome analysis of databases and surveys of various kinds. For those dealing with medical devices, for research and development, for implementation in healthcare, and for controlling the diffusion and pushing for good technologies and hampering non-effective technologies, the book is valuable and highly recommended. Jan Persson | ||