Clinical-Trials Books

Ewing, a Distinguished Service Professor at the State University of New York's law school in Buffalo, employs the same case study format from Minds on Trial: Great Cases in Law and Psychology, this time using only cases in which he has been involved over his 30-year career as an expert witness. The book is well written and packed with details and lengthy segments of trial transcripts from ten riveting, high-profile cases, making it ideal for use as a teaching tool for students of mental health law or the social sciences.

Charles Patrick Ewing's new book, "Tales of a Forensic Scientist" is another treat. Ewing's prose is engaging and witty - written in plain English but in no way is it dummy-downed.

Ewing uses 10 cases in which he was called as an expert witness to illustrate both the benefits and the limits of expert testimony. Indeed, in every case in which he testified as an expert for the defense, the defense was unsuccessful at trial. His purpose in using some of these "losing cases," was not to show that he is unsuccessful as an expert witness. To the contrary, though his testimony had not achieved results at trial, it had collateral benefits in the sentences in the cases of Charlene Brundidge, Judith Neeley and (possibly) Felicia Morgan.

As a lawyer and a forensic psychologist, Ewing aptly describes the differing purposes between the two. A lawyer is an advocate while a forensic psychologist is (supposed to be) a neutral and detached professional. Ewing's bias is decidedly against the expert witness" who acts as advocate (the hired gun). Ewing minces no words in expressing his disdain for the "hired gun." For Ewing, the "hired gun" does a disservice to whatever field he may be testifying. This is not Ewing's first foray into the criticism of the "hired gun (Insanity: Murder, Madness, and the Law). The words of W.B. Yeats come to mind, "But was there ever dog that praised his fleas?"

According to Ewing, too much significance is attached to the testimony of the expert witness. Even when the expert (such as Ewing) renders a dispassionate reasoned opinion, he can still lose the "battle of the experts" to a hack hired gun.

David Salsburg is a statistician with a good knowledge of the foundations of statistics as well as being a practical statistician with a great deal of clinical trials experience. In Chapter 1 he discusses randomized controlled clinical trials. Chapters 2-5 deal with foundational issues in probability and statistics. It leads to the conclusion that hypothesis testing is appropriate for clinical trials and statistical power against alternatives is an important concept for choosing appropriate test statistics but (1)for most practical problems uniformly most powerful tests do not exist and (2)powerful tests can only be found if one is able to meaningfully restrict the class of alternative hypotheses being considered.
In Chapter 6, Salsburg makes the case for restricted tests by providing a real clinical example. Special methods are then covered in the remaining chapters. Chapter 8 deals with resampling approaches including permutation methods and the bootstrap. In Chapter 10, Neyman's often neglected theory of restricted chi-squared tests, is presented.

This is a well written and unusual book that covers methodology not seen in very many biostatistics books. However, these techniques are very relevant to the clinical trials commonly conducted at pharmaceutical companies. It is an important reference source for biostatisticians.

Those interested in statistical theory and its foundational issues will find clear and concise coverage in the first 5 chapters. However if you want more, take a look at Salsburg's new book "The Lady Tasting Tea" which just came out in 2001. In that book he raises all the same issues and more in the context of discussing the great statisticians of the 20th Century.

David Salsburg is a statistician with a good knowledge of the foundations of statistics as well as being a practical statistician with a great deal of clinical trials experience. In Chapter 1 he discusses randomized controlled clinical trials. Chapters 2-5 deal with foundational issues in probability and statistics. It leads to the conclusion that hypothesis testing is appropriate for clinical trials and statistical power against alternatives is an important concept for choosing appropriate test statistics but (1)for most practical problems uniformly most powerful tests do not exist and (2)powerful tests can only be found if one is able to meaningfully restrict the class of alternative hypotheses being considered.

In Chapter 6, Salsburg makes the case for restricted tests by providing a real clinical example. Special methods are then covered in the remaining chapters. Chapter 8 deals with resampling approaches including permutation methods and the bootstrap. In Chapter 10, Neyman's often neglected theory of restricted chi-squared tests, is presented.

This is a well written and unusual book that covers methodology not seen in very many biostatistics books. However, these techniques are very relevant to the clinical trials commonly conducted at pharmaceutical companies. It is an important reference source for biostatisticians.

Those interested in statistical theory and its foundational issues will find clear and concise coverage in the first 5 chapters. However if you want more, take a look at Salsburg's new book "The Lady Tasting Tea" which just came out in 2001. In that book he raises all the same issues and more in the context of discussing the great statisticians of the 20th Century.

Nancy Geller has done a great job in gathering together the top industrial biostatisticians to write chapter articles on some recent advances in clinical trial methodology that is of very useful in today's clinical trials. There are 12 chapters in the book. Each chapter represents a current research paper in clinical trials.

This text is a valuable resource for those struggling with some of the methodological challenges inherent in designing and evaluating patient-reported outcomes assessments for use in longitudinal research designs. The chapters are authored by practicing and recognized experts in their respective areas and most chapters are dense with information and useful illustrations.

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.

As a biostatistician who has written a book on bootstrap methods, been working in the medical device and pharmaceutical industry since 1995 I feel that I am especially qualified to comment on this book. Bioequivalence is a very important topic. When I was at Auxilium Pharmaceuticals Inc., I actually designed an adaptive cross-over trial for bioequivalence. There are many subtleties that separate bioequivalence trials from other clinical trials.

These auhtors are among the top researchers in this field. For example, I know Iris Pigeot and her fine work with Jun Shao at developing valid and consistent bootstrap tests for individual bioequivalence and for her very excellently written expository papers on the subject which were published in the drug information journal.

The author cover all the models, subtketies and regulatory issues surrounding the three types of bioequivalence, average, individual and population. The statistical community was able to develop successful methods for individual and population bioequivalence at the time when the decision was made to favor individual bioequivalence over average bioequivalence in clinical trial studies for the regulatory authorities. These authors were in the thicj of it. They describe all the methods and types of bioequivalence in detail. The book is very well written.

I was so excited about the role the bootstrap played as as methodologic tool and as an accepted method by the FDA that I wrote about it in the second edition of my bootstrap book. Unfortunately I soon learned that the FDA had reversed its stand on individual bioequivalence under pressure from the pharmaceutical companies. To me this is a black eye for the industry and the FDA who by and large have done a great job toward bringing safe and effective drugs to market.

In the chapter about population and individual bioequivalence the authors provide a detailed description of the events that led the FDA to rev erse its decision. My colleague, Terry Hyslop from Thomas Jefferson University Hospital was one of the statisticians who work on parametric methods for individual bioequivalence in her research and her dissertation at Temple University in the 1990s. Here is a woman who did excellent research on a topic that was very exciting to her but has totally moved away from the area after becoming disillusioned by the politics that has affected clinical development.

The authors of this book are very authoritative at covering the research literature and Terry's work is covered nicely in the chapter that covers individual and population bioequivalence. The text also does a very good job of covering the pharmacokinetics associateds with such studies.

For all these reasons I give the book five stars. My only disappointment was that I did not see any discussion of adaptive methods that are now being developed for all phases of clinical trials including sample size reestimation in bioequivalence trials. Well it is a lot to expect everything in one book. This is a book that all biostatisticians should read and perhaps even more so for the FDA statisticians!

Unless you have one of the rare cancers that has a greater than 98% 5-year survival rate, you need to seriously consider being part of a clinical trial.

This book tells what clinical trials are, details the differences between Phase I, II, and III clinical trials, and tells how to find trials that may be of interest to you. The most important part of the book details how to educate yourself to read the informed consent document and the experimental protocol, and how to choose a trial. It details the good and bad experiences that patients have had with doctors and with clinical trials.

Whenever a new treatment is hailed for cancer, it came through clinical trials. If you want the best possible treatment for you or a loved one, you need to read this excellent book, and then make an informed decision.

This is Mark Chang's third book on statistical designs emphasizing adaptive trial designs and I think it will be more popular than his other two successful books. I own all three of Mark's books. I know Mark and have collaborated with him for the past couple of years. Mark is a brilliant scientist and great conceptual thinker. He expresses important concepts very well in all his work. For this book he saw a need for a gap to be filled so that the clinical trial designer could intelligently design any fixed sample size and sequential and adaptive designs without worry about the calculations and mathematical details.

In this text he introduces ExpDesignStudio and provides it for you on the CD that comes with the text. I have checked out the software and it is extremely easy to use. He divides the world of trial design into 9 sections to click on. You simply pick the window to click on that applies to your situation. A dialog box or a sample size calculator comes up and you answer the necessary questions and the sample size comes up. For the fixed designs the software automatically produces the power curve. Mark calls this one stop shopping because he has put into it the fixed sample size deisgns that you would find in a package like nQuery or Power and Precision and also the sequential and adaptive designs that you might see in East or PASS. But each of those packages comes with a high price tag. You could use SAS or R macros but that requires some programming knowledge and in the case of SAS a SAS license. Amazingly you get all this free with the book. If you don't trust the software Mark gives you ways to validate the software in the back portion of the text. He also provides a simulation module that allows you to test and compare the performance of the various design to help make the best choice for your situation. While the East Adapt module provides some of this, most of Cytel's simulation capability requires a special separate software package.

The book itself provides a lot of detail about how to use the software package including a full chapter (Chapter 1) with screen shots and very detailed explanations. In each chapter where a new method is introduced the applications using ExpDesign Studio are given along with some screen shots.

The text itself emphasizes concepts and does not require an understanding of mathematical statistics in any great detail. Parts of it read like a powerpoint slide presentation. Equations are presented sparingly and the details are left to sections at the end of the chapter that can be skipped if the reader is not interested. He also supplies a very good set of references.

Keaven Anderson and I are in the process of writing an elementary test on group sequential and adptive designs for Wiley. Our book will be similar to Mark's but we will have different real world examples and will illustrate Keaven's software and contrast it with the other tools that are available today including ExpDesign Studio.

For a $100 investment there is no way you can get so much knowledge and software capability. It is a must buy for any clinical trials biostatistician and clinical trial practitioner.

This is an essential book for your library if you have ever been tasked to work in this area. Juvenile criminal law has a whole other set of laws and guidelines and if you are the hired expert, you need to know the area. This is a great addition to that expertise. And it's by Grisso, the leader in competence issues.

Dresser and Rosenbaum have carefully put together a valuable resource for anyone involved in or considering clinical research. This is a complete guide to performing research for new clinical products that will help prevent many of the pitfalls that are easily encountered in this line of endeavor. The wording is precise and clear and the outline logical and easy to follow. This is the first and arguably best guide for performing accurate and meaningful clinical research. The authors' strong backgrounds in this field validates their methods and guidelines. An essential for the library of anyone involved in clinical research.