- Email: [email protected]
Trials without tribulations
in survivors of breast cancer treatment was included in this chapter. The next chapter then reviews genetic aspects of breast cancer, with emphasis on mutations in ~53, BRCAl, and BRCAZ, and the following chapter discusses the complex role of growth factors in breast cancer. The authors skillfully managed to summarize this extremely difficult subject by providing simplified models. The next two chapters are written in a very smooth fashion and explain the current status of steroid-receptor research in breast cancer, hormone dependence and resistance, and the controversial role of progesterone in stimulating breast cancer. Antiestrogens and aromatase inhibitors are currently the most important hormonal tools in the treatment of breast cancer. The two final chapters in this section provide two excellent re-
views about tamoxifen and the more recently developed antiestrogens and aromatase inhibitors. The section on prostate cancer opens with a clinical introduction. The next three chapters emphasize the importance of differentiating between carcinomas that need treatment and those with a benign clinical course. Recent research concerning molecular and genetic defects in prostate carcinomas, as well as the role of growth factors and androgen receptors, is presented. Next, two chapters emphasize the role of glucocorticoids in leukemia treatment. Recent knowledge about the relationship of glucocorticoids to apoptosis and its regulation is presented. The final two chapters describe the genetics and molecular biology of acute promyelocytic leukemia and its treatment with retinoids.
We enjoyed
reading
this book
cover to cover. It is a collection lent review articles experts
that were written by
in the molecular
of cancer; probably
from
of excel-
however,
endocrinology
most
readers
focus on the articles
will
that are
related to their information search research. This important contribution the field of hormone-responsive is recommended
or to
cancer
to both basic scientists
and clinicians. Khaled Zeitoun Serdar E. Bulun
Cecil H. and Ida Green Center for Reproductive Biology Sciences University of Texas Southwestern Medical Center Dallas, TX 75235-9051, USA PII SlO43-2760(97)00098-Z
Trials Without Tribulations
This book is a concise account of the reasons why randomized controlled trials (RCTS) are needed, the methods by which RCTs achieve their objectives, and the manner in which results from RCTs should be evaluated, interpreted, and used. Those who read the book should come away from it understanding why a randomized design is better than any other design, why the findings of a single RCT cannot be considered definitive, and why several RCTs using the same hypothesis can produce widely discrepant results. The authors tackle several still contested issues that generate considerable confusion among clinical investigators: the requirement for an “intention-to-treat analysis,” the tenet of “once randomized, always analyzed,” the need to adjust for multiple comparisons and for baseline differences in the characteristics of enrolled patients, and the need to present this material completely and thoroughly in the methods section of a manuscript. The au-
thors’ position on all these issues is unambiguous, but their presentation is nonjudgmental. Difficult or controversial topics are illustrated with several examples from the literature. Academic and practicing physicians who wish to evaluate and interpret published reports of RCTs, or to understand the new reporting requirements of leading medical journals for RCTs, can benefit greatly from reading this book. The work can also be used as a textbook for courses on clinical trial methodology as the discussion of epidemiological concepts is supplemented by statistical coverage of randomization methods, sample size calculations, and survival analysis and response-variable monitoring techniques. The clarity of presentation in the statistical sections is exceptional, as is the case for the rest of the book. Prospective investigators can also use this book to gain an understanding of how RCTs are conducted, as the mechanics of randomization, the recruitment of study participants, the quality control and quality monitoring of the collected data, the assessment of participant adherence, and the termination procedures for RCTs are covered adequately. Readers who are interested only in a
Vol 8, No. 7, 1997
0
Fundamentals of Clinical Trials By Lawrence M. Friedman, Carl D. Furburg, and David L. DeMets. St.
Louis, Mosby, 1996, $49.95 (xvii •t 361 pages), ISBN 0-8151-3356-1.
1997, Elsevier
Science
Inc.,
1043.2760/97/$17.00
few “how to” tips and in resolving specific problems arising over the course of a trial may not find this book helpful. The work is meant to be read in its entirety, as opposed to being used as a reference. For example, the final chapter is devoted to multicenter RCTs, but discussion of the issues that apply to both single center and multicenter RCTs is found throughout the book. Those who need only to look up the basics in order to participate in a multicenter trial as clinical investigators might be better served by other sources of information. Also, there is no special chapter pertaining to the Food and Drug Administration guidelines or to other regulatory issues and requirements. In summary this book is highly recommended for any careful reviewer of the clinical literature. If it is widely read by members of the medical profession, it should help improve the quality of reports of clinical research. Eleftherios C. Vamvakas
Blood Transfusion Service Massachusetts General Hospital Department of Pathology Harvard Medical School Boston, MA 02114-2698, USA PI1 SlO43-2760(97)00099-4
291
views about tamoxifen and the more recently developed antiestrogens and aromatase inhibitors. The section on prostate cancer opens with a clinical introduction. The next three chapters emphasize the importance of differentiating between carcinomas that need treatment and those with a benign clinical course. Recent research concerning molecular and genetic defects in prostate carcinomas, as well as the role of growth factors and androgen receptors, is presented. Next, two chapters emphasize the role of glucocorticoids in leukemia treatment. Recent knowledge about the relationship of glucocorticoids to apoptosis and its regulation is presented. The final two chapters describe the genetics and molecular biology of acute promyelocytic leukemia and its treatment with retinoids.
We enjoyed
reading
this book
cover to cover. It is a collection lent review articles experts
that were written by
in the molecular
of cancer; probably
from
of excel-
however,
endocrinology
most
readers
focus on the articles
will
that are
related to their information search research. This important contribution the field of hormone-responsive is recommended
or to
cancer
to both basic scientists
and clinicians. Khaled Zeitoun Serdar E. Bulun
Cecil H. and Ida Green Center for Reproductive Biology Sciences University of Texas Southwestern Medical Center Dallas, TX 75235-9051, USA PII SlO43-2760(97)00098-Z
Trials Without Tribulations
This book is a concise account of the reasons why randomized controlled trials (RCTS) are needed, the methods by which RCTs achieve their objectives, and the manner in which results from RCTs should be evaluated, interpreted, and used. Those who read the book should come away from it understanding why a randomized design is better than any other design, why the findings of a single RCT cannot be considered definitive, and why several RCTs using the same hypothesis can produce widely discrepant results. The authors tackle several still contested issues that generate considerable confusion among clinical investigators: the requirement for an “intention-to-treat analysis,” the tenet of “once randomized, always analyzed,” the need to adjust for multiple comparisons and for baseline differences in the characteristics of enrolled patients, and the need to present this material completely and thoroughly in the methods section of a manuscript. The au-
thors’ position on all these issues is unambiguous, but their presentation is nonjudgmental. Difficult or controversial topics are illustrated with several examples from the literature. Academic and practicing physicians who wish to evaluate and interpret published reports of RCTs, or to understand the new reporting requirements of leading medical journals for RCTs, can benefit greatly from reading this book. The work can also be used as a textbook for courses on clinical trial methodology as the discussion of epidemiological concepts is supplemented by statistical coverage of randomization methods, sample size calculations, and survival analysis and response-variable monitoring techniques. The clarity of presentation in the statistical sections is exceptional, as is the case for the rest of the book. Prospective investigators can also use this book to gain an understanding of how RCTs are conducted, as the mechanics of randomization, the recruitment of study participants, the quality control and quality monitoring of the collected data, the assessment of participant adherence, and the termination procedures for RCTs are covered adequately. Readers who are interested only in a
Vol 8, No. 7, 1997
0
Fundamentals of Clinical Trials By Lawrence M. Friedman, Carl D. Furburg, and David L. DeMets. St.
Louis, Mosby, 1996, $49.95 (xvii •t 361 pages), ISBN 0-8151-3356-1.
1997, Elsevier
Science
Inc.,
1043.2760/97/$17.00
few “how to” tips and in resolving specific problems arising over the course of a trial may not find this book helpful. The work is meant to be read in its entirety, as opposed to being used as a reference. For example, the final chapter is devoted to multicenter RCTs, but discussion of the issues that apply to both single center and multicenter RCTs is found throughout the book. Those who need only to look up the basics in order to participate in a multicenter trial as clinical investigators might be better served by other sources of information. Also, there is no special chapter pertaining to the Food and Drug Administration guidelines or to other regulatory issues and requirements. In summary this book is highly recommended for any careful reviewer of the clinical literature. If it is widely read by members of the medical profession, it should help improve the quality of reports of clinical research. Eleftherios C. Vamvakas
Blood Transfusion Service Massachusetts General Hospital Department of Pathology Harvard Medical School Boston, MA 02114-2698, USA PI1 SlO43-2760(97)00099-4
291