Clinical-Trials Books

This is a pretty good medical/mystery/thriller book that takes a look from the other side of the tracks. The main character Isabel is working on the Black Feet reservation when several people are struck by the Hantavirus. Isabel manages to save a few but cannot not save everyone. In response to her helplessness she writes a scathing article in a medical journal blaming the lack of a vaccine on the lack of money to be found in combating the virus. Out of the blue Isabel recevies a offer from Immuvac a drug company that had been working on a vaccine but had abandoned it to move on to "greener fields". With the new attention on the virus Immuvac is looking to earn money and gather some goodwill with drug companys that might invest in the first company to come up with a viable drug. Isabel accepts but the new attention alerts her ex-husband to where she is, and he will use any means neccesary to destroy Isabel as she destroyed his career by exposing his medical mal-practice. Also thrown in to the mix is WRI a desperate mining company that is looking to get mining rights on the reservation, this of course brings out local oppostion led by Monty Four-Bear who soon finds himself falling for the doctor even though he thinks she is out use the Indians for her own needs...

This is a pretty good medical thriller. The author does a good job of showing the various sides of people so until the end your never really sure who's good, who's bad and who doesnt matter. Also it is an interesting take on the good and bad with the preservation. Every decison can seems like the Indians are being used or decevied, every choice seems like it can take somthing away. Which makes it easier to see why Monty is so dead set against anything being done on the reservation. All and a good mystery if you like books that take a differnt look at things. m.a.c

A clinical trial of a vaccine for hantavirus on a Blackfeet reservation in Montana is the main story in this book. However, there are several other plot lines included. The story jumps from one situation to another quite frequently early on. Some of the connections are pretty unbelievable, but the characters carry the tale and the story begins to come together about halfway through the book. Towards the end, the pace picks up and tension builds to a satisfying conclusion. An entertaining, if not always believable read.

A great medical thriller that was almost impossible to put down! Action keeps moving, and surprise turns keep it interesting. A great read for those who like medical thrillers with a little romance thrown in - but not enough to distract from the story - just enough to make it believable.

April Christoffersons clinical trial may be her best yet. After reading Edgewater and her last book Protocol which was a wonderful read I was very excited to see her new book out, and she did not disapoint. This was an incredibly well written book by Christofferson, this is a gripping read that is very hard to put down. Christoffesons depiction of the Blackfoot Reservation is very strong, and tribal laywer Montey Four Bear was a great character. It is impossible not to fall in love with Dr. Isabel McLaine who leaves the fast pace and sometimes very sick world of the high tech medicine field to care for teh impovershed Natives on the Blackfoot Reservation. The Protocol is an extremely thrilling read that you won't want to put down, I highly recommend this book.

In her medical thriller, "Clinical Trial," April Christofferson explores the tragic plight of Native Americans who live on reservations. She focuses in particular on the Blackfeet tribe of Montana, who suffer from poverty, substandard medical attention and exploitation by the white man. The heroine is Dr. Isabel McLain, who left the world of high tech medicine to provide medical care for the Blackfeet tribe. She encounters superstition and suspicion from her patients, but she gradually wins them over with her hard work and commitment. Isabel is trying to forget her disastrous marriage to her malicious, soon to be ex-husband, Alistair. The villains of the book are the aforementioned ex-husband, a greedy CEO of a mining company who wants to destroy tribal lands for the sake of profit, and another greedy CEO of a biotech company who also cares for nothing but profit. Added to the mix is a handsome Native American named Monty Four Bear who is a leader and a tribal activist. He is filled with rage at the white man's constant acts of treachery towards Native Americans. "Clinical Trial" held my interest. I loved Isabel, even though her character is somewhat formulaic; she is the typically spunky but vulnerable heroine. Unfortunately, as the book progresses, Christofferson tries to cram too much plot into the novel. Besides the story line with the evil mining company and the biotech company, there is a plot dealing with an FDA investigation involving Isabel and her nasty ex-husband, a tender love affair, a dangerous and disaffected Russian scientist who is also a madman, and a bunch of Native American activists who get involved in a violent confrontation with members of the mining company. The ending is formulaic and more than a little melodramatic. There were a few coincidences that were simply unbelievable. Still, I recommend "Clinical Trial," mostly because of the author's sensitive treatment of the plight of Native Americans and its nicely drawn heroine, Isabel McLain.

This is the standard text on this subject. Recommend you have at least a Master's degree in statistics to take full advantage of this book. This book is too technical for non-statisticians, although they may get some useful infomation from the non-statistical discussions.

Dear Sirs I do not know if I can use this part as a tool for contacting the autour or not; however please excuse me if I have not used it properly: I am a student of epidemiology, and presently we are studying the following book: The Design and Analysis of Clinical Experiments; Joseph L. Fleiss; John Wiley & Sons; 1986. But on page 67 it seems that there is some misunderstandings: When we do a log transformation, in fact we are changing (or shifting) the previous distribution to a normal distribution. Without any doubts in this transformation the means of our previous distributions do not transfer to the means of the new distributions! In fact these are the medians of the previous distributions which are transferred to the place of the means of new distributions (of course if we presume that the new distributions are almost perfectly normal) and by finding the confidence interval of the difference of the means of new distributions (lambda1 - lambda2) we are finding the CI of ratio Median1/Median2. In this way it seems reasonable that the formula 3.25 be changed to Median1/ Median2. It would be very kind of you if you help me in this problem!

With best regards Dr. Shahrokh Izadi

This book was first published in 1986. As Fleiss states in his preface, the intention is to fill a gap in the standard texts on experimental designs by emphasizing and illustrating those that are useful in clinical studies. This book was clearly marketed for the rapidly growing and highly regulated pharmaceutical industry. In addition to the classic experimental designs, Fleiss covers cross-over designs and repeated measure designs that are important in clinical trials. He writes clearly and deals with the important issues in clinical trials including potential biases, blinding, randomized controls, multiple comparisons and repeated measures. The book starts off with a chapter that emphasizes the effect of measurement error and also provides some simple experiments on reliability of measurements.

There is a wealth of methods included, many different designs and various parametric and nonparametric analysis techniques. It is aimed at biostatisticians in the pharmaceutical industry and the medical research field. The book is very much suited for an advanced undergraduate or graduate level course for students majoring in statistics or biostatistics. The level of mathematics is high but not excessively used. Mathematical results on sample size determination are deferred to an appendix.

The Wiley editors choose only successful books to be included in their Classics Library series. The intent of the Classics series is to take popular books by distinguished authors and create a paperback edition that may be more affordable than the hardcovered edition still in print. It is not a revision of the book. This book entered the Classics series in 1999.

It is a great reference source and I plan to consult it a great deal in the future. The only drawback to it that I see is that it is not up to date. The last 15 years has seen many advances in group sequential methods, Bayesian designs and longitudinal data analysis that this text misses. So Fleiss' book is not one stop shopping for a clinical biostatistician but it does offer a lot and presents it eloquently.

With regard to reviewer Izadi's comments on Amazon, I think the appropriate way to ask this question is really to write the author. Since it is here in print for the readers, I will attempt a reply. I think there is a misinterpretation of the terminology. When Fleiss refers to mean logarithms he is not referring to the population means on the log scale but rather the logarithm of the population mean on the original scale. With the latter interpretation equation 3.25 makes perfect sense. It is the former interpretation of the parameters that the reviewers point addresses. The importance in the example is to demonstrate the lack of robustness of t or F tests to non-normal (e.g. lognormal) data and to show that tests and confidence intervals can still be accomplished using the normal theory after the transformation. The key point is that it is the ratio of the parameters that is transformed into differences of the log of the parameters.

This book was first published in 1986. As Fleiss states in his preface, the intention is to fill a gap in the standard texts on experimental designs by emphasizing and illustrating those that are useful in clinical studies. This book was clearly marketed for the rapidly growing and highly regulated pharmaceutical industry. In addition to the classic experimental designs, Fleiss covers cross-over designs and repeated measure designs that are important in clinical trials. He writes clearly and deals with the important issues in clinical trials including potential biases, blinding, randomized controls, multiple comparisons and repeated measures. The book starts off with a chapter that emphasizes the effect of measurement error and also provides some simple experiments on reliability of measurements.
There is a wealth of methods included, many different designs and various parametric and nonparametric analysis techniques. It is aimed at biostatisticians in the pharmaceutical industry and the medical research field. The book is very much suited for an advanced undergraduate or graduate level course for students majoring in statistics or biostatistics. The level of mathematics is high but not excessively used. Mathematical results on sample size determination are deferred to an appendix.

The Wiley editors choose only successful books to be included in their Classics Library series. The intent of the Classics series is to take popular books by distinguished authors and create a paperback edition that may be more affordable than the hardcovered edition still in print. It is not a revision of the book. This book entered the Classics series in 1999.

It is a great reference source and I plan to consult it a great deal in the future. The only drawback to it that I see is that it is not up to date. The last 15 years has seen many advances in group sequential methods, Bayesian designs and longitudinal data analysis that this text misses. So Fleiss' book is not one stop shopping for a clinical biostatistician but it does offer a lot and presents it eloquently.

With regard to reviewer Izadi's comments on Amazon, I think the appropriate way to ask this question is really to write the author. Since it is here in print for the readers, I will attempt a reply. I think there is a misinterpretation of the terminology. When Fleiss refers to mean logarithms he is not referring to the population means on the log scale but rather the logarithm of the population mean on the original scale. With the latter interpretation equation 3.25 makes perfect sense. It is the former interpretation of the parameters that the reviewers point addresses. The importance in the example is to demonstrate the lack of robustness of t or F tests to non-normal (e.g. lognormal) data and to show that tests and confidence intervals can still be accomplished using the normal theory after the transformation. The key point is that it is the ratio of the parameters that is transformed into differences of the log of the parameters.

If you could only have one book on clinical research, this should be the one. It is comprehensive, and presents much of the material in tabular format that greatly facilitates learning. I have been in the drug development business for over 30 years and still refer to this text on a regular basis.

A basic handbook for management of clinical trials. This is a "must" reading for anyone who deals with clinical trials. It covers areas of protocol development, regulatory issues in human clinical trials. There is a detailed section on data collection, handling data and statistical issues.Also an introduction to project management.The book contains a large amount of tables easy to read and with great "tips".

This is a decent book, but packed with padding. You have to read 50 pages to get 1 page worth of useful information. Spilker is adequately familiar with clinical trials, but his writing style tends to meander a lot.

If you're a complete novice, it may be of use, but you will outgrow it after a few months. And unfortunately, the book is somewhat outdated--clinical trials are much more sophisticated now. I'm not sure what the person below is talking about--using it after 30 years in the industry!?! Anyone who's been in the industry for more than couple of years should know everything there is in this book.

Working in a small biotech start-up company, I think this book is a great reference especially if you have limited resources and interested in conducting drug development the "right" way. This text covers all areas of drug development and useful for people in regulatory affairs, project management, clinical affairs, and data management.

I have previously reviewed a more recent book in the SAS series "Pharmaceutical Statistics using SAS: A Practical Guide" that Dmitrienko and Chuang-Stein also edited. Both books are very similar because they provide a variety of chapters by top experts in the field. Each chapter is well written and understandable to nonstatisticians who do clinical research as well as for statisticians who can use it as a reference and guide to the appropriate techniques to handle various common situations. I highly recommend this book to anyone who analyzes clinical trials data.

Good history of methods with lots of citations. Not so good for practical application. Programming language is not fully explained and results are difficult to understand and reproduce. Limited output shown. I want Ron Cody to write an "applied statistics for clinical trials" workbook.

This is an excellent easy to follow book, from which both statisticians and interested medical professionals can greatly benefit, I believe, because I am working with both. It has helped me a lot in my graduate project on data analysis of laboratory animal trials.

Is there anything bad about this book? It's really hard to find flaws. It provides everything anyone would ever want to know about clinical research participation, the clinical research process, etc. The only (really the only) way it could improve would be by having current facts and figures. Some of them are from 2005, but most are recent.

What a great book! I recently became interested in this field, and The Gift of Participation gave me so much useful information. While comprehensive and informative, it is certainly not difficult to read. The author does a great job at explaining and is incredibly clear. Highly recommend!

This book was very easy to read. It is written in plain and simple language. Any questions you might have about participating in a clinical trial are answered in this book.

I can get this through the Temple bookstore for $175.00 brand new - and I thought that was expensive!! Unfortunately, I have the older edition and need to buy the new one. The older edition is a good book, so I imagine this one is just as informative. Gives a very good picture of drug development.

The book is a comprehensive collection of Regulatory Affairs information. The book lacks an index. Thankfully, the table of contents is detailed enough to find most of the information one might be looking for.

I once was told that in drug development regulatory affairs there wasn't an equivalent to a Gray's anatomy or a Goodman & Gilman's pharmacology textbook. Thus I had to jump right into the maze of FDA guidelines and the code of federal regulations (CFR). After I discovered and read the first few chapters of this book I went back to the experienced regulatory affairs person that told me that there wasn't such a textbook and said "here is Gray's anatomy for regulatory affairs!" Indeed, the book covers all regulatory aspects of drug development providing an extensive and clear description of all the regulatory requirements for each phase as well as providing an objective interpretation of the laws. What I most like about this book is that it is self-sufficient in that it summarizes and pulls the relevant guidances and regulations together for each phase in such a manner that the text flows easily and one does not have to stop reading it to look for the original guidance or CFR text. Even a copy of the relevant forms is included in each chapter (for instance form 1571 in the chapter about the IND) so that one can better follow the author's discussion about it. This self-sufficiency seems to be a major advantage of this book because in other regulatory manuals the norm seems to have a text full of links or advices to read the guidance before proceeding to the next sentence of the book which is annoying and many times unfeasible if you don't have immediate access to the myriad of FDA issued documents. Another good thing is that the author also provides down-to-earth but very important information such as who is the present director of a division, why did he/she achieved that position, who was the previous director, where/he she is right now. Overall it is the best textbook I've seen so far in regulatory affairs for prescription drugs.

I read this book in conjunction with a clinical research associate training course. It provided an excellent background and filled in the gaps of the often times confusing and vast drug development process. The inclusion of important FDA regulations and a variety of reference sources adds to the continued usefullness the book in the day-to-day life of a CRA. Plus, being bound in a 3-ring binder allows the addition of information, articles from periodicals, seminar handouts, etc. This book helped me during my training and I will refer to it as my career progresses.

The Clinical Research Monitor Handbook, by Deborah Rosenbaum and Fred O. Smith is an excellent resource for monitors, and also for everyone involved in the conduct of a clinical trial! This thorough, well-organized, and easy-to-read book explains just about every aspect of a clinical trial. Topics addressed include FDA regulations, site selection, monitoring, data management, adverse event reporting, and more. Nowhere else can a person find such practical and useful information in one concise format. Anyone who wants to pursue a career in clinical research should have a copy! As a project manager, I have found this book to be extremely useful and highly recommend it. It's an excellent investment and well worth the money.

Susan Ellenberg is a Professor of Biostatistics at the University of Pennsylvania. Prior to that she played a prominent role in the development of statistical methods for clinical trials at the US Food and Drug Administration. She made major contributions to the Harmonization Committee's ICH Guidelines on statistical methods in clinical trials, particularly the Guideline E9.

Tom Fleming and David DeMets are Professor of Biostatistics at University of Washington and Wisconsin University respectively. They are among the world's leading experts in group sequential methods. Fleming is famous for the O'Brien-Fleming stopping rule that bears his name and DeMets is known for the Lan-DeMets alpha spending function approach to group sequential analysis.

With such experts and excellent writers you get what you should expec t, an authoritative treatment of the practical and technical aspects of the monitoring of data by Data Monitoring Committees (DMCs, previously called Data Safety and Monitoring Boards, DMSBs). These committees look at interim data from a clinical trial to judge whether the trial should be stopped early for safety concerns. In their charter they can set-up their own rule or can debate and make subjective decisions. These authors through their experience present examples and also formal statistical methods that can be used not only to stop for safety concerns but also to stop if safety and efficacy are demonstrated earlier than anticipated in the design. Also if the trial is clearly going to be unsuccessful they can stop for futility as well.

The development of group sequential methods and adaptive designs make a formal analysis for the DMC possible. For a detailed account of group sequential methods see the book by Jennison and Turnbull. For adaptive designs the two books by Mark Chang (one co-authored with Professor Chow) are excellent. Another excellent book similar to this text is the text by Proschan, Lan and Wittes which covers the theory and applications more than the aspects of the DMC.

All or almost all significant clinical trials involve Data Monitoring Committees (DMCs; also known as Data Safety and Monitoring Committees; DSMBs). These bodies provide independent oversight of the safety and operation of clinical trials. This book is a well organized and clearly written discussion of the operation of DMCs/DSMBs. Very practically oriented, the book discusses virtually all aspects of DMCs/DSMBs from their rationale to the nuts and bolts of running committee meetings. In addition to being comprehensive, this book is distinguished by the liberal and appropriate use of numerous concrete examples to illustrate many of the issues that come up in the operation of a DMC/DSMB. This book should be read and owned by anyone serving on a DMC/DSMB. Anyone heavily involved in clinical trials should be familiar with the contents of this book.

This was shipped as indicated and rec'd on time. Book was in excellent condition and has been one to keep as a reference.

good basic introduction to pharmacology and ototoxicity for beginners

For the money, I did not feel that this book offered as much information/detail as I would have liked. A considerable amount of the content is regulations/documents that are readily available on the web from a number of sites. Why pay this much for what you can print from the web in five minutes?

Check it out before you buy it!

Does a good job of outlining the basics in an easy to digest format. We've made it part of new IRB staff and member training.

"Protecting Study Volunteers in Clinical Research" provides a very comprehensive overview of the federal regulations which govern clinical research in a very concise and accurate manner. It is very easy to read. It makes for an excellent educational tool for investigators, coordinators, administrative personnel, and IRB members. I would recommend this book to anyone who is involved in clinical research.

I thought this was an excellent outline for Researchers, IRB members, Research Compliance Officers, etc. It covers the history of human research, ethics, roles and responsibilities of researchers and the institutions, federal regulations, behaviorial research issues and publication of study results. As a new Research Compliance Officer, it has served as an excellent learning tool for me. I am sharing this book with our new IRB members to facilitate their orientation to the IRB. Plus, it is a good way for PI's to get CEU's for their licensure.

This manual for investigative sites provides considerable insight and highly useful information into the protection of study volunteers. As an IRB member concerned with the ethical treatment and care of research subjects, I would absolutely recommend this book as "must reading" for clinical investigators and research coordinators. The regulations and glossary of terms are both current and easy to refer to. This book would serve as a great primer for new IRB members. William Hirschhorn

Covance, Director of Clinical Research Education, Investigative Site Services (e-CRO) Adjunct Professor in Pharmaceutics Temple University School of Pharmacy Quality Assurance - Regulatory Affairs Graduate Program