Clinical-Trials Books

This is a true account of a well-known Napa Valley family that is torn apart when daughter, Holly, reveals repressed memories of sexual abuse. The story covers details of the family's early years to allow the reader to understand the dynamics and the people involved later on when the accusations begin. This is a very in-depth coverage of a very dysfunctional family.

I connected well with author Moira Johnston. She tells the story smoothly, in a matter-of-fact manner. This is a long read, but I was held captive right up to the end. A lot of legal facts and psychology jargon are included, but the author does well to explain and break it down for the layman. The legal issues focus on the reliability of memories, the involvement of therapists and doctors, medical malpractice, medical science, and involves the input of experts from various psychological fields.

The author also brings the emotions of the family into play, as well as friends, business associates, the community, and even long-distant supporters who attended the trial. Moira Johnston writes from a neutral position, laying the facts without imposing personal influence.

I enjoyed this book and I'm glad I read it.

I first learned of this fine volume--named from an expression born during the Salem witch trials--while at a skeptic's meeting the keynote speaker for which had gone through a bogus "therapy" which ended her marriage and nearly her life. The person who told me of the book pointed out that the book's alleged victim, the one who'd "recovered" her memories--one of the turns for the worst of the victim culture--is now a therapist. Why does that not surprise me?

The author, Moira Johnston, did a remarkable job of examining all dimensions of the incident. In fact, her closing chapter lists how she proceeded with the investigation. While reading the text, I felt she was clearly in favor of the alleged culprit, Gary Romano, whose life was forever changed, and nearly destroyed, by the incident. But after reading the technique Johnston employed, I had to reconsider. The case which Mr. Romano had filed against the therapists and the institutions in which the memories were "recovered" provided enough evidence to convince a jury that there had been malpractice, i.e., there was not enough evidence to convince the jury that Romano had raped his daughter Holly, the future therapist--repeatedly according to her between the time she was a toddler until she was about 16--despite her therapists' encouraging her to believe that he had. So the author at best took the same stand as the jury.

The story was not atypical of recovered memory cases. A young woman suffering from her own problems, in this case bulimia, went to a therapist. Johnston provides a thorough background by showing that of the 46,000 of the type of therapist Holly was seeing, half of them were in California. (The requirements expected of that sort of therapist were comical at that time too!) They therefore, she surmises, had to develop a niche for themselves. The "recovered memory" niche was just becoming popular. One such case had convicted a father--also in California--not long before this trial of having killed his daughter's friend a couple of decades before. The ostensible evidence of this crime was memories which the daugther allegedly "recovered" while she was under the care of another therapist. (That case was later overturned. But not to get sidetracked...) Holly couldn't understand what was going on with her, and her therapist helped her "recover" memories of having been repeatedly sexually abused by her father. After Holly insisted that she partake of the "truth serum" sodium amytal, and her therapist(s) encouraged her to believe what she "remembered" while blitzed on that stuff, she confronted her father with the "facts." He was caught totally off guard and, to make a long story short, lost is wife, his job, and nearly everything as a consequence.

Ramona wanted to file suit against the therapists but his attorneys insisted that (1) no such case had ever been filed by someone not directly affected by a therapist's malpractice (i.e., patient/client)and (2) Holly's therapy records, probably the prime evidence, could not be used as evidence as they're strictly confidential. When Holly eventually filed criminal charges against him, those files could be opened, and the case began, setting a precedent for malpractice against "mental health professionals."

At the same time this memory recovery fad was picking up steam, scientists were studying memory, but that was still pretty much confined to the Ivory Tower. There were "true believers" in the recovered memory concept, among them Holly and her mother Stephanie. There were, however, scholars who refuted the concepts. And they became some of Romano's key witnesses, challenging the claims of Holly's therapists whose livings depended on their encouraging the ill-founded concept.

The trial itself was a sideshow. Between discussion of Gary Romano's sexual idiosyncrasies--personal details that would embarass anyone not truly insane--and Stephanie's claims that were transparently false, even jury members began to wonder where the justice system was headed.

The verdict: The therapists were guilty of malpractice. However the benefits to Gary were few. He'd been making upwards of $500,000 a year on the job he lost--partly because of the gossip following the allegation, according to one element of the case. He was awarded the equivalent of one year's salary. Nonetheless, Romano felt vindicated. He HAD set a precedent; the recovered memory "movement" was given a profound setback (followed by many since the book's publication).

I have to hand it to Johnston. While she did, at least inferrably, side with the jury, she did include other sides of the story. Her investigative technique included conversations with all parties including defense attorneys and Holly and Stephanie and their allies. And her eye for detail is remarkable, from the mannerisms of the witnesses and their potential influence on the jury and the audience to the clothing chosen by each.

And, after her detailed description of what happened--this isn't a short read but full of relevant detail--she includes a chapter on what continues to happen with the "recovered memory" nonsense. She included pieces from prestigious law journals, written by, for example, feminist ideologues who feel the Romano verdict was more evidence of patriarchal lack of concern for women's well-being--and those of other feminists who remind their fellow attorneys that a concern for the rights of the accused needs to overshadow ideological shading.

In short, it's a fine book that I solidly recommend to anyone who's been accused of anything based on something as shady as "recovered memory," anyone who knows anyone who has, or anyone who will be. And that means just about all of us. So it may be time to consider the punishment, not just fines, for unethical "mental health professionals," prosecutors, and law enforcement quacks who capitalize off of bogus concepts such as "recovered memory."

A thoughtful reader will ask how this book can be purported to be objective when a key person (Holly Ramona) was never interviewed. A key to the slant of this book is in the title itself, "Spectral Evidence," which is suggestive of "no evidence." What, then, could account for the estrangement of Holly, her sister and mother, from Gary Ramona?

What and how do we really remember? Is memory ever really "the truth"? And why are all these people remembering things that supposedly never happened, yet are willing to destroy their lives in the process of asserting their perception of reality? Although this book has more questions than answers, it is very thought provoking and enlightening.

Destined to be a "classic" of all the books on the memory wars. The author masterfully recounts a tragic case of alleged incest by a father against his daughter, and captivates and educates the reader. This book excellently reounts the family's background, the therapy and the confrontation, the science and the theories and counter-theories involved, and the court case and its aftermath. This is a must read for anyone interested in false and recovered memories, and the legal cases spawned by the same.

Overall, an enjoyable read. The character definition was a little stereotypical. The plot was somewhat predictable, yet satisfying. It became a page-turner as I got deeper into the book. Better than average.

I loved this author's previous book, FINAL REMEDY, and enjoyed this one even more. Dylan Ice is a truly flesh-and-blood character we come to care about deeply, and the twisted political-medical intrigue he finds himself embroiled in is shocking yet all-too-possible. Daniel Steven brings together a knowledge of medicine, the law, and human nature to weave a story I literally couldn't put down until I knew how it would end--and I didn't know that until the very last page. I recommend Daniel Steven enthusiastically to all fans of deeply textured thrillers, and I eagerly await his next novel!

The authors have experience conducting clinical trials in the pharmaceutical industry and this shows in their approach. All the issues that arise in an NDA submission to the FDA are covered. In the introduction the authors describe the regulatory process and the role of the FDA. They even provide organizational charts for the FDA Center for Drug Evaluation and Research. I have been working as a senior biostatistician for medical device companies for the last 5 years. Most of the trials I have worked on were regulated by the FDA and a number of issues that have been important to the FDA include (1) multiple comparisons, (2) intention-to-treat versus per protocol analysis, (3) pooling centers, (4) baseline data and demographics, (5) data monitoring and (6) safety. They are all covered in chapters 11 and 12 of this book.

Chapter 10 emphasizes sample size determination and interim analyses are covered in chapter 9. Randomization and blinding are covered in chapter 4. These topics are emphasized because of their importance in regulated clinical trials. One does not find them covered very much in other statistics texts on survival analysis or clinical trials.

The mathematics level is intermediate. The authors write well and incorporate the important practical interplay between the statistician, the clinician and the physician.

They provide many good references. The book is a good reference for anyone interested in clinical trials. Points are illustrated through the use of real trials.

Recent advances in Bayesian methods, resampling and meta analysis are not covered but most important topics are covered including group sequential methods.

The authors have experience conducting clinical trials in the pharmaceutical industry and this shows in their approach. All the issues that arise in an NDA submission to the FDA are covered. In the introduction the authors describe the regulatory process and the role of the FDA. They even provide organizational charts for the FDA Center for Drug Evaluation and Research. I have been working as a senior biostatistician for medical device companies for the last 5 years. Most of the trials I have worked on were regulated by the FDA and a number of issues that have been important to the FDA include (1) multiple comparisons, (2) intention-to-treat versus per protocol analysis, (3) pooling centers, (4) baseline data and demographics, (5) data monitoring and (6) safety. They are all covered in chapters 11 and 12 of this book.
Chapter 10 emphasizes sample size determination and interim analyses are covered in chapter 9. Randomization and blinding are covered in chapter 4. These topics are emphasized because of their importance in regulated clinical trials. One does not find them covered very much in other statistics texts on survival analysis or clinical trials.

The mathematics level is intermediate. The authors write well and incorporate the important practical interplay between the statistician, the clinician and the physician.

They provide many good references. The book is a good reference for anyone interested in clinical trials. Points are illustrated through the use of real trials.

Recent advances in Bayesian methods, resampling and meta analysis are not covered but most important topics are covered including group sequential methods.

This is really the first really good book for statisticians on quality of life issues and methods with authoritative references. The author provides practical advice for qol studies in a clinical trials setting and provides sage advice on design of the study. Actual quality of life surveys are discussed and the importance of defining objectives is emphasized. Some real cancer trials are discussed and used as examples throughout the book. There is detailed treatment of missing data and how to deal with it including the latest statistical methodology. Much of the methodological development could apply to hard endpoints as well as qol endpoints.
I got this book and a good taste of its contents in a short course presented by the author at the Joint Statistical meetings in New York in August 2002. The only drawback of the book is that it does not spend much time on the issue of instrument validation. Also the author's experience is with cancer trials in an academic setting. The issues related to conducting qol surveys for a manufacturer that needs labeling or FDA approval efficacy and safety approvals is a prospective that I would like to see but the author does not have.
Excellent examples illustrated in SAS and SPlus.

This is really the first really good book for statisticians on quality of life issues and methods with authoritative references. The author provides practical advice for qol studies in a clinical trials setting and provides sage advice on design of the study. Actual quality of life surveys are discussed and the importance of defining objectives is emphasized. Some real cancer trials are discussed and used as examples throughout the book. There is detailed treatment of missing data and how to deal with it including the latest statistical methodology. Much of the methodological development could apply to hard endpoints as well as qol endpoints.

I got this book and a good taste of its contents in a short course presented by the author at the Joint Statistical meetings in New York in August 2002. The only drawback of the book is that it does not spend much time on the issue of instrument validation. Also the author's experience is with cancer trials in an academic setting. The issues related to conducting qol surveys for a manufacturer that needs labeling or FDA approval efficacy and safety approvals is a prospective that I would like to see but the author does not have.

Excellent examples illustrated in SAS and SPlus.

not only include the basic ideal about the survival analysis but also the concept about the sample size needed for trail design

A well-written introductory book. Broad range of material make it a good reference for new comers in survival analysis.

This is one of two excellent books on group sequential methods and adaptive designs. All three authors are ASA Fellows. Wittes and Proschan have worked at the NIH and Proschan formerly worked at the FDA. Gordan Lan has published widely on group sequential methods and has developed software with David deMets that can be downloaded for free from deMets' website at the University of Wisconsin. Lan and deMets developed the theory of alpha spending functions that are commonly used in software such a EaSt (Cytel Corporation) to help determine an appropriate shape to the stopping boundary. Two group sequential methods with markedly different spending functions are the Pocock design anf the O'Brien-Fleming design. I have written a detailed book review for Technometrics, that also compares the book to Jennison and Turnbull's text. Both of these books will be classics. my review will appear in the May 2007 issue of Technometrics.

The topics listed in the table of contents of the book are really interesting. On the other hand, the notations used in the book make it so much more difficult to read. For example, the letters chosen for many variables used have no relation at all with their meaning, so that constantly, throughout the book, you need to go back to previous chapters. Also, various statistical results are just used, without any proof or at least hints for proof. Therefore, one needs to read this book while having another graduate stats inference book at hand.

A good book on clinical trials of the first ste

Mark Elwood's new book will surely enable you to discover the Clinical Trials' world in an uncommon way. Focused on the causation perspective of
medical clinical problems, you will get into the different types of trials from the design aspects to the most accurate and precise statistical methods to analize results. You will learn to evaluate research findings with confidence and improve your outcomes. "Critical Appraisal of Epidemiological Studies and Clinical Trials" will be a useful tool for anyone who wants a genuine search of evidence-based medicine whether designing a clinical trial or simply studying up-to-date medical literature by sistematically reviewing its relevance, validity and results to specific situations.

Like most books in this series of monographs on statistics and applied probability this book is a well-written and concise treatment of the topic by an expert in the field. In addition to this book I have a similar text by Stephen Senn. I prefer Senn's book because of his writing style and his emphasis on the controversial issues that arise when considering a cross-over design. Also doing the analysis correctly in SAS can be a little tricky and Senn points out the care needed to correctly estimate the components of bariance particularly the within subject variability.

Whitehead has proposed a triangular stopping boundary that has optimal properties under certain assumptions for a fully sequential trial. The method can be extended to the group sequential approach but I believe it does lose its optimality properties. Jennison and Turnbull provide the best and most comprehensive text on group sequential methods. Whitehead present this approach and has software that he used to construct such a group sequential design. My colleague, Patrick Rojas, had the book and was considering the Whitehead design for one of his study trial. I don't think Whitehead's approach is anywhere near as popular as the family of models that is used in East. The East models include Pocock designs and O'Brien - Fleming as special cases and the Lan-DeMets alpha spending function approach is also available in East. None of this is available in Whitehead's software and none of these ideas are covered much in the book. That is why I prefer Jennison and Turnbull. Also East now has a lot of adaptive design capability.