Book Description
Studies that are unimpeachably thorough, non-political, unbiased, and properly designedÂ… These are the standards to which everyone in clinical research aspires. Yet, the difficulties in designing trials and interpreting data are subtle and ever present. The new edition of Clinical Trials in Oncology provides a concise, nontechnical, and now thoroughly up-to-date review of methods and issues related to clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the major pitfalls that are seemingly inherent in these processes. This edition includes a new section that describes recent innovations in Phase I designs. Another new section on microarray data examines the challenges presented by massive data sets and describes approaches used to meet those challenges. As always, the authors use clear, lucid prose and a multitude of real-world trials as examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Although the book focuses on cancer trials, the issues and concepts are important in any clinical setting. Clinical Trials in Oncology, Second Edition works to improve the mutual understanding by clinicians and statisticians of the principles of clinical trials and helps them avoid the many hazards that can jeopardize the success of a trial.
Customer Reviews:
Knowing What Works in Health Care.......1999-12-15
I should begin by admitting that I had the opportunity to review this little masterpiece in manuscript. Good then, it's even better now.
It's good because it informs the reader, in sober prose, how to determine what works and what doesn't in medical practice, and what's safe and what isn't. It's good because it reveals what can go wrong when anecdotes ("it worked for me!") substitute for sound research as the basis for clinical practice. And it's good because it shows how serious are the consequences of even subtle failures to observe protocols in designing and carrying out clinical trials.
It is reassuring to read of the care and precautions advocated for government-sponsored research; it is accordingly unsettling to contemplate the pressure that commercial interests (drug companies, for-profit hospitals, equipment manufacturers) might bring on researchers to cut a few corners.
After reading "Clinical Trials" I came to appreciate that case studies, longitudinal studies, and retrospective questionnaires, so frequently hyped in the press and on television, are no substitute for actual well-designed and well-executed experiments. Because you and I are different, certainly genetically and probably in other essential ways, what helps you may well harm me. Only the proper application of statistics in designing clinical trials and in analyzing data from them can distinguish what's generally valuable from what's useless (however plausible and authoritatively touted it may be). Although the authors had the good taste to reject the aphorism, usually attributed to a nameless statistician, that "if experimentation be the queen of science, then statistics stands as the guardian of the royal virtue", its pithiness may give the reader the crucial insight into why alternative modes of research are untrustworthy.
Some readers may feel disheartened to learn the truth that many, probably most, promising therapies prove, when adequately tested, worthless, and some may feel in some fuzzy way that to accept this reality is cruelly to deny hope to those who need it badly. On the contrary, this book makes it clear that to offer false hope is the ultimate cruelty, for without experimentation there can be no knowledge, and without knowledge there can be no real hope.
Notwithstanding the slightly technical nature of this book (yes, there IS a chapter with mathematics), I recommend it highly for the general reader who is interested in such topics as personal health care, alternative medicine, managed care cost containment, and the like. Buy a copy for yourself, and, if you feel philanthropic, you might consider donating a copy to your health care provider. The world would be better if doctors' waiting rooms (like hotel rooms with their Gideon Bibles) all had a copy of "Clinical Trials in Oncology" available for patients' perusal.
Average customer rating:
- Not just for cancer victims!
- Mandatory Reading for Brain Tumor Patients
- A New Approach, A New Attitude
- A must-read for brain tumor sufferers
- The Bible of GBM
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Surviving Terminal Cancer: Clinical Trials, Drug Cocktails, and Other Treatments Your Oncologist Won't Tell You About
WilliamsfBenA
Manufacturer: Fairview Press
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Brain Tumors: Leaving the Garden of Eden--A Survival Guide to Diagnosis, Learning the Basics, Getting Organized, and Finding Your Medical Team
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Damn The Statistics, I Have a Life to Live!: Coping with a Brain Tumor My Personal Story
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Living with a Brain Tumor: Dr. Peter Black's Guide to Taking Control of Your Treatment
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Navigating Through a Strange Land: 2nd Edition: A Book for Brain Tumor Patients and Their Families,
ASIN: 1577491165 |
Book Description
Describes how to use the Internet and other sources to learn about experimental drug trials, effective forms of alternative medicine, and other breakthroughs with the potential for dramatically improving the odds of successful treatment.
Customer Reviews:
Not just for cancer victims!.......2007-01-12
This book was written by Dr. Williams, an eminent and widely published experimental psychologist in the field of learning theory and many other related fields. Dr. Williams was diagnosed in 1995 with a glioblastoma with, for all practical purposes, zero chance of survival. He immediately went on a quest for maximizing his chances of survival by evaluating and combining traditional and nontraditional treatment approaches. Today, in 2007, he is alive and well. This book should be of interest for anyone, even if not affected by cancer personally. I found it a remarkable account of how one can deal with catastrophic diagnoses and seemingly hopeless situations. It also critiques current FDA policies and conventional medical practice by providing a wealth of facts, literature citations, and well-developed logical arguments. There is also a very readable discussion of the statistical approach, written for a lay audience, of experimental design, and of implications for the methods for the social and medical/biological sciences. This book includes a systematic, open, thoughtful, and fair evaluation of so-called alternative treatments. The evaluation of these alternative treatments is so convincing because it was undertaken by someone like Dr. Williams, who knows the scientific approach so well. I call this book "inspirational" for anyone who has to tackle important life-and-death decisions.
Mandatory Reading for Brain Tumor Patients.......2006-11-12
The previous 5-star reviews of this book are right on target, so I mainly just want to echo their praise for this book (in addition to thanking these reviewers for steering me towards this book).
Ben Williams is a true hero for those with brain tumors, and to a large extent other cancers also. Drawing on both his own experience and his extensive review of the literature, he outlines the potentials and serious limitations of conventional medicine, while also informing readers of the vital importance of complementary medicine, especially "off-label" drugs and nutritional supplements.
He advocates a "cocktail" treatment approach which combines many agents, both conventional and unconventional, to simultaneously target multiple cancer mechanisms. This approach is gradually becoming accepted as the best approach, although this is happening far too slowly because of the many problems with how conventional medicine is organized. As a result, you are likely to encounter resistance from your doctors, and perhaps even family members, so be prepared to be very persistent.
If you or someone you care about has been diagnosed with GBM or another type of brain tumor, this should be the first book you read, and you should do so as quickly as your circumstances allow. However, even before you do that, be sure to read Ben's annual update entitled "Treatment Options for Glioblastoma and other Gliomas," which is available online at no cost at the Virtual Trials website.
Also be sure to look up the related and valuable work of Jeanne Wallace (see her Nutritional Solutions website) and John Boik (see the Oregon Medical Press website). Also have a look at my website, which can be found by Googling "brain tumor treatment" and "Alvi".
Good luck and best wishes!
A New Approach, A New Attitude.......2006-09-05
I found this book inspirationally. Not because the author beat the odds in surviving a cancer considered "terminal" by all of his physicians, but because he did it by rationally setting out to explore all of his options and did not just let the "experts" tell him what to do.
The most important lesson from this book for those of us exploring cancer/tumor treatment options is that we have to research beyond what we are likely to hear from our medical specialists. Each of them will have their particular bias (e.g., surgeons tend to want to cut things out, oncologists will tend towards other strategies).
Moreover, as the author points out, the range of treatments the medical specialists are willing to recommend are sharply limited by custom to things that have passed the FDA-mandated stage III clinical trials. Many very promising treatments have only passed stage II trials; and because of cost, never go beyond that. Nor do medical specialists in the U.S. look at successful treatments that are well-accepted by the medical specialists in other countries.
And while this book does discuss "alternative" medicine, that is not the focus. The author does evaluate some "alternative" medical approaches, debunking several of them but also notes where medical science has validated some of them.
Another critical point the author makes is that treating cancer should be like treating AIDs. Because of the probabilistic nature of any single treatment successfully eradicating a cancer, a "cocktail-style" drug regiment has the best chance of succeeding. He makes a powerful and convincing argument that this one change in approach could make a huge difference in reducing the recurrence of cancer and boosting the effectiveness of current treatments.
One more key insight of the author: the large pharmaceutical companies have no financial incentive to pursue promising cancer treatments that they can not patent and thereby recoup their multi-billion dollar investment. Because of that, the author believes many promising treatments are not fully explored. He is sharply critical of government policies that have not closed this gap.
CFC
A must-read for brain tumor sufferers.......2006-07-09
Dr. Williams' book is a blow by blow record of how he guided his own survival in spite of his doctors and the constraints of the FDA in overcoming a glioblastoma. His program was well-researched and gives excellent suggestions for options in taking an active part in one's own survival. Should be read by all cancer patients, particularly those suffering with brain tumors. He also published an annual online update of the information contained in the book.
The Bible of GBM.......2006-03-22
I bought this book when my dad was diagnosed with Glioblastoma Multiforme (GBM) in late 2005. At first I was skeptical of his harsh criticism of the medical institution as a whole, but as my dad's surgery, chemo and radiation went on, I realized how 100% RIGHT ON Dr. Williams is in this book. You MUST buy this if you know someone suffering from this agressive form of brain cancer. Our family purchased three copies so each of us could have their own for reference. If you don't buy any other book about GBM, buy this one. Dr. Williams has survived ELEVEN years from diagnosis with a type of brain cancer that has an average survival time of 14 months.
Book Description
A compendium of cutting-edge statistical approaches to solving problems in clinical oncology, Handbook of Statistics in Clinical Oncology, Second Edition focuses on clinical trials in phases I, II, and III, proteomic and genomic studies, complementary outcomes and exploratory methods. Cancer Forum called the first edition a "¼good reference book for statisticians who will be designing and analyzing cancer trials." The second edition includes over 1000 references, more than forty world-renowned contributors, and 300 equations, tables, and drawings. During the five years since publication of the first edition, there has been an explosion in the technological capabilities supporting genomic and proteomic research, which are is now firmly implanted in clinical oncology. Reflecting these developments, the second edition contains a new section devoted to analyses of high-throughput data and bioinformatics. Previous chapters of the first edition have been revised to reflect current state of the art in their respective domains. The intended audience is primarily statisticians working in cancer and more generally, in any discipline of medicine. But oncologists too will find the material accessible and will benefit from a rudimentary understanding of the fundamental concepts laid forth in each chapter. Completely revised while keeping the features that made the first edition a bestseller, this is the best single source for up-to-date statistical approaches to research in clinical medicine. More than just an update of the handbook that became the gold standard, this second edition brings you fully into the genomic era of medicine.
Book Description
This thoroughly updated and expanded second edition of Beverly Teicher's widely used classic survey provides a step-by-step guide to anticancer drug development from initial design through FDA approval. The authors have included new material on the use of high throughput screening in industry, on specialized in vitro/in vivo procedures employed by the National Cancer Institute (NCI) in preclinical drug evaluations, and on nonclinical testing to support both human clinical trials, as well as trials of biologic oncology products. The chapters on phase I, II, and III clinical trials and on novel phase II clinical trial designs for targeted therapies have been significantly updated, along with those on cancer drug development in Europe, working with the NCI, and the FDA's role in cancer drug development and setting requirements for approval.
Book Description
Phase I trials are a critical first step in the study of novel therapeutic approaches. They follow years of development in the laboratory, and precede Phase II and III trials where testing of the drug becomes more focused yet is conducted on a wider scale. The primary goals of Phase I trials are to identify the recommended dose, schedule and pharmacologic behaviour of new agents or new combinations of agents, and to describe the adverse effects of treatment. In cancer therapeutics, such studies have particular challenges. In general, because of the nature of the effects of treatment, most studies are conducted in patients with advanced malignancy, rather than in healthy volunteers. Furthermore, the endpoints of these trials are usually measures of adverse effects, but increasingly investigators are interested in assessment of the effects of new drugs on their molecular target. These factors render the design, conduct, analysis and ethical aspects of Phase I cancer clinical trials unique. This book provides a practical guide to Phase I cancer trials and is appropriate for oncology trainees or specialists interested in understanding cancer drug development. Topics covered include preclinical requirements needed for first-in-man investigation of new agents, principles and statistical design, ethical considerations of Phase I studies, pharmacokinetics, pharmacodynamics, and studies in special populations. Practical information on protocol development, study activation and conduct, as well as how to write reports of the results, are incorporated. Numerous appendices offer document templates to use in Phase I study development, and examples from actual Phase I trials are interspersed throughout, making this a true 'hands-on' guide. In an exciting time in cancer research, as the number and type of new potential anti-cancer drugs is increasing dramatically, this book provides much needed information on the first stage in getting a drug approved.
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Nutrition and Cancer Prevention
THOMAS ED. MOON
Manufacturer: CRC
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ASIN: 0824779932 |
Book Description
Scientific advances have led to the recognition that many chronic diseases such as cancer may be preventable. In this volume, 36 contributions test cancer prevention hypotheses, attempt to interpret their results, and provide a guide to the background, rationale, and selection of cancer prevention a
Book Description
Clinical Trials in Cancer provides concise, accessible and practical information on the practicalities of planning, designing, conducting, analysing, reporting, and interpreting phase III clinical trials predominantly, but also single-arm and randomized phase II trials. The book shows clearly how recent developments and current thinking can be implemented. Information on the need to decide and measure realistic target differences in trials, the conduct and interpretation of interim analyses, patient advocacy, good clinical practice, the study of quality of life, the role of meta-analyses, and informed consent and other ethical issues are also covered. This book will prove invaluable for medical, statistical, and biological cancer researchers, health care professionals, and researchers in the pharmaceutical industry. Trial sponsors, principal investigators, members of data monitoring and trial supervisory committees, specialists invited to provide independent assessments, and many others involved in all aspects of research related to clinical trials should also find this book helpful.
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Cancer Informatics
J., Ed. Silva
Manufacturer: Springer
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Binding: Hardcover
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ASIN: 0387953280 |
Book Description
Cancer Informatics: Essential Technologies for Clinical Trials describes the National Cancer Institute¿s vision of a Cancer Informatics Infrastructure (CII). By exploiting the best that the Internet and information technology have to offer, the CII will facilitate clinical trials, for all who are involved, including the patient along with the myriad of health professionals involved in cancer trials. To bridge the chasm between discoveries and best clinical practices, the editors describe the CII and how it can function to expedite the clinical trial life cycle, facilitate faster and safer drug development, and make more appropriate treatment choices available to cancer patients. Presented in four comprehensive sections edited by leading experts, the book highlights: ¿ E-commerce ¿ Digital libraries ¿ Standards development ¿ Public health informatics ¿ Common data elements (CDEs) ¿ Clinical trials information systems ¿ Consumer education and support Cancer Informatics: Essential Technologies for Clinical Trials is an indispensable guide to clinical trials. Its contributors speak to oncologists and primary care physicians, as well as researchers, trial managers, administrators, informaticians, and consumers. Today, science is extending our knowledge of genes, proteins, and pathways, and pharmaceutical companies are developing more and more new therapies. In this rapidly changing world, the technologies that cancer informatics provides are essential to efforts to translate cancer research into cancer care, control, and, ultimately, prevention. John S. Silva, M.D., Center for Bioinformatics, National Cancer Institute Marion J. Ball, Ed.D., Vice President, Clinical Solutions, Healthlink, Inc.; Adjunct Professor, The Johns Hopkins University School of Nursing Christopher G. Chute, M.D., Dr.P.H., Professor of Medical Informatics, Head, Section of Medical Information Resources, Mayo Clinic Judith V. Douglas, M.A., M.H.S., formerly Associate, First Consulting Group Curtis P. Langlotz, M.D., Ph.D., Assistant Professor of Radiology, Epidemiology, and Computer and Information Science, University of Pennsylvannia Joyce. C. Niland, Ph.D., Chair, Division of Information Sciences, Director, Department of Biostatistics, City of Hope National Medical Center William L. Scherlis, Ph.D., Principal Research Scientist, School of Computer Science, Carnegie Mellon University
Book Description
"The Best Options for Diagnosing and Treating Prostate Cancer" is a general help for anyone who has this disease. Chapters include:
* The best changes to make to possibly prevent prostate cancer
* The best tumor marker for monitoring prostate cancer for treatment
* The best choice for staging localized prostate cancer
* The best method for conducting a prostate biopsy
* The best method for applying external beam radiation to prostate cancer
* The best complementary therapy for prostate cancer patients
* The best radiation treatment for prostate cancer
* The best treatment for multiple bone sites
* The best combination of drugs for prostate cancer
* Developing a diagnostic and treatment plan by considering the "bests"
Customer Reviews:
something is wrong somewhere.......2000-06-07
I have just read 'The Best Options for Diagnosing and Treating Prostate Cancer' published by Health Education Literary Publisher, on which I could not find any information, but their ISBN suggests that they are a very tiny publisher - maybe self published?).
It is an extraordinary biased book giving the 'best' methods for possibly preventing, monitoring, staging, conducting a biopsy, treatment etc. It assumes the reader has already read and is aware of the basics of prostate cancer and, therefore, does not cover the material that is provided by most other books - it is the next stage on (which is good). The author (James Lewis - a non-doctor survivor) really puts himself on the line and open to challenge. Nevertheless it's the most helpful book I have read to date. It doesn't give wide ranges of percentages - it's specific, it doesn't pussyfoot about. For me, it is great book as it unashamedly gives his 'gold standard' for any treatment. It also has the most comprehensive bibliography (30 pages and about 250 references) so it appears to be exceptionally well researched.
It is highly evangelistic in its selling of Dr. Frank Ritz' prostRcision treatment at the Radiotherapy Clinics of Georgia, claiming that cancer free survival rates are at least equal to and probably much better than surgery, even that performed by Dr. Walsh's Johns Hopkins team - and with the added benefits of significantly less chance of erectile dysfunction and other side effects.
If what he says is anywhere near the truth there doesn't seem to be any other choice but to have prostRcision.
I find it disturbing that other books only seem to mention prostRcision as an aside. The books published by the American Cancer Society and the Mayo Clinic don't even make a single reference to prostRcision. So something is wrong somewhere!
Have you read it? If not, at this stage of my limited knowledge, I would highly recommend it.
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