Clinical-Trials Books

Actually one of the best marketing book applied for good sales. Nothing special but everything is in. Very well presented, comprehensive, and straightforward to the point. Can actually work for any product than a medical one.
And a very nice way to present it : drawings, slides etc..
This person is a master in marketing and that's why his book is very good as well and this is why I paid the (high)price!!! the book itself is a good marketing lesson as a product, then take a look at it twice...
I am Vice-president in the medical device, coming from sales and know what it means to sell, having seen a lot of bad marketers and sales rep.

This book deftly summarizes both courtroom skills and lawyering skills needed to deal with clients and opposing counsel prior to trial. The book gives the law student a wonderful overview of the entire legal process from a lawyer's first meeting with a client to a trial verdict. The book has humorous anecdotes throughout, and the examples are well thought out. One overlooked answer to many problems that cause conflicts is addressed here ("Disputes about Deals"): a client in a business dispute sometimes has to admit to making a mistake and simply say, "I'm sorry."

Hegland uses his wit and skill as a law professor to teach beginning lawyers practical skills and share insights so they will have the skills to communicate better with their clients and be successful in the courtroom. Note that this book is similar to (but more recently written than) Trial and Practice Skills in a Nutshell by Hegland.

This is a fascinating read for anyone interested in medical issues--particularly the interesting world of neurology--but also for those who appreciate reading about courtroom dramas.

The book is divided into short chapters, each dealing with a different patient who ended up dead or disabled due to doctor/hospital negiligence. Dr. Klawans explains how he became an "expert witness" for these patients, and how the legal system works regarding malpractice suits.

This is written in a clear, sometimes humorous manner and is understandable to the layperson. Dr. Klawans was not only an expert neurologist, but a fine author as well. A truly enjoyable read that I could not put down.

As a programmer in the pharmaceutical community, I have been waiting years for a book like this. Validating data for clinical trials is crucial to not only portraying the data accurately but also to save money! I believe that pharmaceutical companies should purchase this book for each and every employee who works in or around clinical data.

This is an excellent volume that should be read by anyone involved in clinical research. It is both scholarly and accessible. The arguments are well-developed and the rich case histories and examples are well-referenced. Menikoff brings into sharp relief the need to rethink the relationship between clinician and investigator and between patient and research subject. The volume should not be seen as a denial of the importance of clinical research but rather as a call for IRB members, investigators, and patients to think carefully about what clinical research is and what it is not.

I haven't read this book but have a hard time trusting what is presented inside when the cover picture stands out as contrived and myth-like itself. With a device to measure blood pressure in the background, a lab-coated villain stands with a needlessly large and empty syringe posed at a random place on a patient's forearm. Note that the syringe holding hand is gloved but the one that touches the point where needle penetrates skin is not!(Perhaps to hide the fact that there is no needle attached?) So is this supposed to be a shout-out to us that the medical profession is sucking us dry as we lie around in calm submission?

Don't get me wrong. I have no desire to see this scene portrayed realistically or graphically on the cover. And I DO believe that we, and sometimes the medical community, have been sold a bill of no-goods. This is just a heads up thought. When you have a message to send, why spend the time, money and energy to publish a book and then cover it with a picture that keeps some people from ever opening it up to have a look. If you ever publish, get a better editor.

Convincing revelation of the nature and causes of common medical myths that are costing the country Billions of dollars and hurting rather than aiding our health.

Just some of the information Kauffman provides on blood pressure myths:

A. Did you know that the higher blood pressure reading should be 100 + your age? Neither did I.

B. Older women get higher blood pressure than older men, but live longer nevertheless and there's no need for medication unless blood pressure exceeds 180 (and even then the medication is not really of much help compared to the nutritional supplementation of magnesium, vitamin C and omega 3 EFAs). This is NOT what we've been told - if we had, pharmaceutical companies would make billions less each year.

C. When allowance for age is made, less than 5% of older people should be treated for high blood pressure (and even then the medication is not really of much help, especially compared with the benefits of nutritional supplementation of magnesium, vitamin C and omega 3 EFAs).

D. Conventional advice about exercise and diet does not work, after which they give you the drugs.

E. Diuretics: everyplace you might search, internet or otherwise, is unanimous that diuretics are beneficial for high blood pressure. Kauffman shows that the maximum possible benefit is 1.5 days extra of life after 5 years of taking diuretics! Yet diuretics have awful side effects; that's why you find strong warnings against taking diuretics for weight loss purposes.

F. Vasodilators, Beta-Blockers, Calcium Channel Blockers, ACE Inhibitors and Angiotensiin Receptor Antagonists are all proven to either be more dangerous than beneficial or to be working only because, despite terrible side effects, they help with retention of potassium and/or magnesium. Why not just take magnesium and potassium supplements? Oh yes, of course, because drug companies do not profit from nutritional supplements.

There's so much more. There's no real evidence that moderate drinking of red wine is beneficial yet the far superior anti-oxidant capability of 1 gram of Vitamin C goes unremarked; cancer cure rates have not changed much in the last forty years, the "success rates" merely refer to a 5-year survival rate but with terrible quality of life after chemotherapy and the like. Perhaps worst of all: for over a decade there has been a quick and simple blood test for many types of cancer, costing just $200, (the Anti-Malignin Antibody in Serum (AMAS) test) but most doctors don't know of it!

The book is not an easy read, but is so loaded with useful information you will constantly refer to it. If you care about your health, or that of those around you, this is a must read book.

AN "I HATE FRUITS AND VEGETABLES" DIATRIBE
1. In order to stress his love obsessive love affair with fats, Kauffman unfairly demonizes all carbohydrates by lumping the good (raw plant foods) and the bad (refined and processed plant foods) together and never admitting to, or pointing out, the difference. That people who consume 25% of their calories in sugar are not going to avoid degenerative diseases is an obvious and well-known fact. Even Dr. Robert Atkins, perhaps the world's premiere high-fat diet advocate of our time, said (in DR. ATKINS' NEW DIET REVOLUTION):

a. "Sugar has no nutritional value and is directly harmful to your health. Despite vociferous attempts to defend it, there are hundreds of studies that clearly show how deadly its effects can be."

b. "Sugar is a metabolic poison."

c. "And sugar is the Western world's most frequently consumed carcinogen."

d. "So you plainly see that sugar has been shown epidemiologically and just-plain-logically to be a strong candidate to be the principal dietary cause of cancer, perhaps a much stronger candidate than fat."

e. "As a dozen studies report, there is solid evidence that it is sugar or refined starch that may be a main cause of colon and rectal cancer."

Despite being aware of such revealing comments by a high-fat advocate like Dr. Atkins, to make his point, Kauffman still refused to separate sugar and other refined carbohydrates from the good carbs. THIS CAN ONLY BE CALLED EXTREME DECEIT.

2. This book is poor in truthfulness in other ways. For example, on page 58, Kauffman says, "...until his [Atkins'] death from trauma..." The actual cause of Atkins' death was never made public since there was either no autopsy, or if there was the results were never made public. This was well-publicized in the media at the time.

3. Further, this book lousy in giving all the facts. Kauffman never mentions vegetarian pioneers like Pythagoras (94), Sir Isaac Newton (85), John Harvey Kellogg, MD (96), Sir W. Arbuthnot Lane, MD (87), Norman W. Walker, PhD (99) or Bernard Jensen, DC (93) - their ages at death are in parentheses. Except for Dr. Julian Whitaker, he never mentions Nathan Pritikin and his followers like John McDougall and Neal Barnard. Any reference to Dean Ornish is noticeably absent.

Going a step further, the fact that our Late Paleolithic ancestors ate a moderately low-fat diet (C=46%, F=21%, P=33%) is never mentioned by Kauffman. To see S. Boyd Eaton, MD et al.'s original paper (and be able to download it) about this, go to Google and enter the triad , with quotation marks as shown. Clicking on the single item retrieved by Google, reveals a copy of the original paper that can be download. Then see Table 1.

Once more, with regard to honesty, in the Myth 10 chapter on cancer, Kauffman draws heavily from Ralph Moss' books; rather, it should be said, he cherry picked from Moss. Kauffman evidently never gave an iota of thought to including anything about Max Gerson, MD, which, in all fairness, should have been done as Moss felt it to be extremely important.

4. The lapse of good science by Kauffman in the more than occasional total SNAFU, like Table 3-1, is extremely disappointing. Table 3-1 purports to show that high cholesterol makes a human more immune to malaria by comparing children's all-cause death rates in Ghana, where malaria is epidemic, with children's all-cause death rates in the U.S., where there is virtually no malaria.

5. On the positive side, this book is good in pointing out how drugs are abused, misused, and overused. In addition, this book rightly emphasizes how the ACS, NCI, other large national organizations, and corporate entities, especially drug companies, regularly lie to the public about progress and cures.

Overall, the negatives win by a very wide margin.

In summary, this book has left me with the conclusion that the book is scientific trash and I would not recommend it to anyone.

This was exactly what I was looking for, INFORMATION and while it isn't a book for the beach, I will read and refer to it for many days,months and years. Would not part with this book.

If you need a quick intro into trial design that is well written and easy to understand this is a great book. It served as a nice survey of the topic. Some ares are just detailed enough other will stimulate you to look further in a more authoritative book on the topic. This allows the reader to see the concept and get a good general understanding. I have enjoyed coming back to this book again and again as each chapter is very concise.

This book does exactly what it says in the title. Get this if you are looking to get your basic fundamentals straight in the area of clinical trials.
The best part of this book is the way the chapters are lined out and how the authors explain certain concepts based on their own practical experiences and illustrating from their own studies.
You do not need to read the book in order. You can read the chapters for a specific topic and there is no continuity among them. And I mean this in a good way because if you want to read Chapter 9 you can do that and you do not need to flip through earlier pages a lot. Maybe a couple here and there.
But overall I really enjoyed this book. A good buy if you are in this area.

One of the biggest challenges most of us have in managing a complex clinical trial is in keeping all the complexity simple. Clinical Trials have gotten longer and the number of processes, regulations, and others involved in a typical trial process has increased too.

That's why I appreciate this books approach. What separates this book from the others that I've read is that it was written by individuals who really understand the challenges and nuances of a clinical trial from experience and how to communicate their experience simply. It truely sticks to the fundamentals.

Thank you to the authors for this book.

Brian Hughes
bhughes@crfhealth.com
CRF, Inc., www.crfhealth.com

Have no choice. It is required as textbook for my clinical trial course. So I suppose it is good without comparison with other clinical trial books.

FUNDAMENTALS OF CLINICAL TRIALS, 3rd ed., by Lawrence M. Friedman, et al, is 360 pages long. The book contains 19 chapters, each concluding with a carefully chosen collection of 30 to 100 references. One of Lawrence Friedman's other books, the informative and lucid, "DATA MONITORING IN CLINICAL TRIALS," is centered around case histories. In contrast, this book is not focused on case histories.

In chapter 3, we learn that, in capturing response variables, e.g., efficacy or adverse events, the investigator needs to be careful not to count one event more than once, where the same event repeatedly presents in the same subject (page 22). We also learn that the response variable must be capable of being assessed in all subjects, not just in a subgroup of the subjects. We learn that a surrogate may or may not reflect clinical outcome, for example, where tumor response is a surrogate for survival of the subject (page 26). Undesirable aspects of measuring surrogates are disclosed (the surrogate might be hard to measure), and desirable aspects of measuring surrogates (they are needed for accelerated approval) (page 26).

Regarding inclusion and exclusion criteria, we learn that these must be defined carefully in the Clinical Study Protocol (CSP). For example, "headache" is not a good criterion, since it is not easily or objectively determined (page 33). For example, where age of the subject is a criterion, the CSP must define if this is the age attained at the time of baseline screening, or at some other time (page 32). We learn the benefits of having an available mechanism of action (MOA). Availability of a MOA enables the investigator to set forth subgroups in the CSP, for example, subgroups with severity of vessel growth, or subgroups with different locations of vessel growth (page 33). (Vessels growing in the eye, in a study of treatment by photocoagulation.) In other words, if the MOA is known, specific subgroups (and not others) can be chosen to include in the study, thereby reducing cost of the study and improving the number of favorably responding subjects.

"Today's homogeneous group may be considered heterogeneous tomorrow."

We learn about the fact-pattern where a subject who initially meets the inclusion & exclusion criteria, during the trial develops a condition that removes the subject from meeting all these criteria. The authors suggest that, where this happens, the subject should be taken off the study drug, but kept in the study for the purposes of analysis only (page 36). (Obviously, the P.I. of any trial will need to decide what to do if this fact-pattern presents.)

We learn that exclusion criteria need to include conditions that prevent the diagnosis of the events of interest (page 36). For example, we learn that exclusion criteria need to list conditions that would likely cause the subject to die shortly after the study is initiated (page 36). (For example, this would include infection with flesh-eating bacteria or glioblastoma.)

Regarding age as an inclusion/exclusion criterion, we learn that for any given disorder, the cause might be different in the young and old, as for the disorder of myocardial infarction (page 38). Also, we learn that exclusion criteria should list persons likely to be harmed by the treatment, or persons unlikely to comply with the study (page 39).


In chapter 4, we learn about the problem of changes in names of diseases, and that these might change during the course of the study (page 49). Unfortunately, as this point in the book, the authors do not tell the reader about naming systems for disorders or for adverse events (AEs), for example, MedDra and Common Terminology Criteria for Adverse Events (CTCAE).

In chapter 5, we learn about the desired ration of study drug subjects/control subjects. We learn that a common ratio is 2:1, and that this ratio is especially desirable for gaining knowledge on AEs (page 62). Once it is decided what ratio to use, the subjects are randomized. We learn that randomization can be by way of a coin toss, but we also learn why this method must not be used. This is because, "if the blind is broken on one participant, the entire sequence of assignments is known." (page 64). The authors then tell us about a better method of randomization, blocked randomization, where coin toss is used to determine if the next 4 subjects will be in this group AABB, or ABAB, or BAAB, or BABA, or BBAA, or ABBA. Delving further into details, we learn about stratified randomization and that this "in a sense, breaks the trial down into smaller trials" (page 68). We also learn that for huge studies, it won't matter much if you determine strata (for each subject) before or after randomization is done.

In chapter 6, we learn various reasons for blinding. For example, if a physician knows that a subject is a control (placebo), he is likely to compensate by prescribing additional treatment to that particular subject (page 84). We also learn that sometimes machines used for diagnostic purposes, e.g., platelet aggregation, might need to be modified to prevent inadvertent unblinding (page 87). We learn that sometimes pills degrade, so that the resulting discoloration can produce inadvertent unblinding. We also learn that it is better for every vial to have its own code, and worse for all vials (having study drug) or all vials (having placebo) to have the same code.

Chapter 7 (sample size) and chapter 14 (survival analysis), are entirely statistics.

In chapter 8, we learn once again that stratification can be done before randomization, or later on at the time of analysis (page 131). We learn that subgroups should be defined ahead of time, and that subgrouping should be based on BASELINE DATA (and not be based on data collected after unblinding). We are told that if subgroup is defined, for the first time, after analyzing unblended data, then this subgroup is appropriately used only for subsequent trials (page 132). Regarding baseline data, we are warned that it needs to be decided if baseline data is to be collected with the subject on his currently used drugs (or if it is to be collected with the subject taken off all drugs) (page 133).

In chapter 9, we learn of problems with recruitment: lack of funding for screening; failure of physicians to refer subjects, over-estimation of prevalence of the disorder in the general population; too stringent entry criteria. We also learn of a related problem, where the study actually begins, but where the expected outcome does not occur with the expected frequency (pages 259-260). Also, we learn techniques for improving recruiting: relax inclusion criteria, extend time for recruiting, add more recruiting centers, refrain from telling placebo/standard of care subjects that they are in a study, re-testing of potential subjects until they meet inclusion criteria, accept smaller number of subjects.

In chapter 10, we learn about problems in data quality. We learn of the problem where definitions for a symptom or an AE can be different from a definition in common use, and the definition set forth in the CSP (page 158). We learn of incompletely filled out forms, badly calibrated equipment, mislabeling, overt errors in making calculations, and inter-observer variability, and the fact that different physicians participating in the study might use different methods to read an EKG or to interpret histology, and various ways of referring to the same chemical (e.g., free propanolol versus propanolol HCl) (page 159-160). We learn various methods to QC a clinical study, e.g., sending drug samples to a lab for analysis.

Chapter 11 provides definitions of expected AEs and unexpected AEs. An expected AE is one that, based on previous knowledge of intervention, is known or likely to occur (page 171). We learn that it is good for the CSP to provide definitions of AEs and of primary and secondary responses (page 172). We learn differences in acquiring AEs by check lists and by open-ended questions during interviews. We learn that documenting AEs are especially important for trials that attempt to find that the only difference between the study drug and standard of care is fewer AEs with the study drug (page 175). We learn of the phenomenon where a subject might get tired of reporting a particular AE. We learn that subject who hold a job might have compliance problems, where a drug needs to be taken for a plurality of times during the day (page 177).

Chapter 12 discloses quality of life questionnaires, and tells us that the better way to phrase questions is: "Do you feel that your quality of life has changed?" and that the worse way to phrase the question is: "Has your quality of life improved?" The authors tell us that "the critical factor is not actual performance, but the degree to which one's perception of functioning changes." (page 195) We learn that the questionnaire can give wrong information, where the subject has experienced some tragedy (bereavement; work layoff) or some great success (child graduating college). We learn that better quality results might be obtained where a relative fills out the questionnaire. A criticism of this chapter, is that it fails to include an example, e.g., EORTC questionnaire, Karnofsky 11 point scale, or WHO Handbook for Reporting Results for Cancer Treatment (5-point scale).

Chapter 13 tells us how to increase subject compliance: shorter trials are easier to maintain compliance, trials conducted in hospitals (vs. at home), simple dosing regimens, seriousness of the disorder being treated, educating subjects in the drugs and disease, birthday cards to subjects, telephone reminders to subjects, lower turnover of study staff, paying subjects taxi fare for getting to clinic, presence of a spouse, using special containers for study drug (pill count), providing subjects with phone # of investigator, give subjects a brochure, tests on blood and urine to monitor adherence, adding an inert chemical to study drug that can be measured in blood or urine.

Chapter 15 tells us that the Greenberg Report was the basis for the Data Monitoring Committee (DMC), and that its goals are to protect subjects from harm and to ensure integrity of the trial. We learn that it is the DMC that produces recommendations on continuing, termination, and protocol modification. A criticism here is that this chapter fails to emphasize that the DMC's role is only to provide recommendations, and NOT actually to terminate or modify the study. We learn that the DMC can unblind the data, but that this should only happen when trends begin to emerge in either direction (drug causes harm or drug shows efficacy) (page 249). We learn that the DMC should meet when 10%, 25%, 50%, 75%, and 100%, of the outcomes have been observed. We are warned that "trends may emerge and disappear, especially early in the trial." We learn that the DMC contemplates the impact of missing data, participant adherence, whether results are consistent across all subgroups, whether data is unusual at one particular center (page 253). This chapter provides us with a list of studies that were stopped early. We learn that hasty (and incorrect) judgment was avoided, because of a discovery of a delay in missing data (page 255). We learn that stopping can be applied to only one of the subgroups. We learn about a drug that improved a surrogate (improved exercise tolerance) but that unfortunately led to greater deaths (page 258). This fact-pattern was a good example of an emerging negative trend (trend of deaths). The difficult nature of the DMCs decision here, involves deciding if the negative trend of the study drug is less harmful than negative trend of positive control drug (page 259). We also learn that, where there is an emerging positive trend, it still might be a good idea to continue with the trial, in order to discover AEs that present only after longer treatment. Finally, we learn that a CSP may have instructions for increasing sample size, e.g., by extending recruitment phase, and that this decision should be linked to # of events (not to # of subjects) (page 260).

The book fails to disclose the time-line of the drug-application process, and fails to show how all the different regulatory documents fit into each other. This shortcoming can be remedied by FDA REGULATORY AFFAIRS by Pisano and Mantus. The book does provide some elementary statistics, but not enough to learn from scratch. This shortcoming might be remedied by ESSENTIALS OF MEDICAL STATISTICS by Kirkwood and Sterne. Also, I recommend the Lange series book on statistics, for its excellent discription of Kaplan-Meier curves.

I also recommend DATA MONITORING IN CLINICAL TRIALS, by the same three authors as the book currently under review.

This book is wonderful. Coming back from Iraq my girlfriend could only quietly accept my sudden anger at 'little old ladies' who got too close to me with their shopping carts in the megamall. But with her quiet acceptance on so many things changed about me, there were still small fights between us when I could not go out with her friends (who I felt were shallow and petty... Odysseus' attitude toward the rich civilians) or why I hated to drive downtown, and how our sex life was really going through the motions and so on and so forth. So many things in this book are mirrored in my own life and the lives of friends who have come back with me. So many of our behaviors and attitudes and great anger are accepted at first by friends and loved ones but they grow tired of us quickly and do not understand why we cannot change back into the people we were before the war.

Every NCO is charged with taking care of his/her men. NCOs mentor and guide the troops under their care. Read this book and talk to your troops. Read this book and talk to your families. Every deploying unit should buy this book and give it to the spouses left behind, that they can read it while the deployment lasts, that they can talk about it and be ready for the changed men and women we will be after coming back home.

We cannot entertain ourselves and distract ourselves from the fact that our troops are coming back changed. The hard-won lessons learned from world wars 1 and 2 in the care of combat stress were utterly forgotten in treating those coming back from Vietnam and a nation said 'never again'. Yet those hard won lessons on what combat stress are and how to deal with it were, again, thrown out and we are having to learn it all again. Thank you to the veterans of past wars, my heroes, who have stepped up with their stories to welcome me back and to guide me back through my own homecoming.

SSG Black, Oregon Army National Guard 2004-2010, USMC 1989-1994

This book powerfully uses myth to capture the reality of the human experience. Myth helps us place our experiences, whether on the battlefield or in everyday life in context. Shay masterfully weaves ancient and modern into something that is very beautiful and very human.

Another great book about Homer's Odyssey as it relates to the adolescent experience is Rethinking Adolescence: Using Story to Navigate Life's Uncharted Years by Jay D'Ambrosio.

[...]

As those of us who live and work with war trauma know, for many, the Vietnam War is not over.Jonathan Shay writes:
"The Vietnam veterans that I have worked with were treated shabbily by both the political right - who scorned them as 'losers'...and by the political left, who held them responsible for everything vile or wrongheaded that led us into the war, was done during the war, or came after the war."
I encountered a similar situation in my work with Russian veterans of their war in Afghanistan. Dr. Shay's book provides his readers with valuable insights into the challenges facing soldiers returning from a controversial war.His book is a must read for those who care about the mental and physical health and well being of our returning veterans.
Anngwyn St.Just Ph.D. Director of the Arizona Center for Social Trauma and author of " Relative Balance in an Unstable World:The Search for New Models for Trauma Education and Recovery ( 2006 Carl-Auer Verlag, Heidelberg)

The author is an expert on the return of combat veterans. The literary references are terrific. For instance, the 'Siren Song' cliche' is generally misunderstood. The Sirens are NOT singing flowery or sentimental or erotic or false lyrics to weary sailors. No, the story goes that only THOSE WHO WERE IN COMBAT would recognize the Sirens' stories as exactly truthful, therefore hypnotic. (I did not know the importance of the particular mythology until this book described the context.) That and much much more...

After reading it and puzzling over it for a couple of months I can honestly say I understand what I have put my wife through for the last 36 and one-half years.

Every combat veteran needs to read this book. Just for the understanding if nothing else. Oh, if it is not too late, get some help too.

An excellent book. I would say it is a must for anyone involved in clinical research. Useful both for experts and beginners.

I am a declared fan of this book. I teach on how to do research to med students and this book is very straight forward and practical.
I believe that this book is a must for physicians that want to do research and have no time to learn everything. It is designed for everyone to pose their research question, select the design (which I believe is the right way to do research)(first 6 chapters) and then read the chapters about the selected design. It has additional chapters about searching funds(seldom included in research books) and ethical issues. My favorite chapters are the first two for beginners with no research experience (research question), the fifth (hypothesis) and the sixth (sample size), and the questionnaire chapter. The questionnaire chapter is a masterpiece, it teaches about difficult subjects in a practical and very easy way for physicians to understand. I have let away most of my books about questionnaires aside with this chapter (for physicians, for research specialties you might go to other books). And in this new edition the data management chapter has included the use of software for data analysis.
I hope the Spanish version of this 3rd edition will be available soon.

I enjoyed the class and this book was pretty helpful, but probably not worth the price.

This is a really great book. It is well written and seems easy to follow. IT was required for my Intro to Research class. It will be helpful as well in the development of my capstone/research project for graduaiton.

This book was good for me, give you the best about clinical research from A to Z, very simple, up to the point

Dr.David Ginsberg guides the reader through the complex world of clinical research.The book is an excellent prime to understand the drug research industry.I was fascinated by the simplicity and yet profound way that this author teaches the wisdom that a researcher has to have in order to be successful in this science.It will inspire every reader to want to do good.

A fairly good book but crowded with the author's bias towards clinical research and the various regulatory agencies responsible for oversight.

Anyone thinking about getting involved in clinical research will enjoy and profit from reading Dr. Ginsberg's excellent guide to the business and craft of conducting clinical trials. He outlines the entire process from start to finish, made understandable with personal anecdotes garnered from 15 years of research. For Doctors, clinical research can be lucrative, professionally rewarding and capable of providing state of the art medical therapies to their patients. If you want to do it right, this guide is a savvy plan to do just that. A good read and a convenient reference for physicians, staff and patients considering participation in medical research.

Dr.David Ginsberg guides the reader through the complex world of clinical research.The book is an excellent prime to understand the drug research industry.I was fascinated by the simplicity and yet profound way that this author teaches the wisdom that a research has to have in order to be successful in this science.It will inspire every reader to want to do good.

This book is a "must read" for anyone contemplating doing clinical research,or wanting to learn more about how to conduct clinical studies. Written from the perspective of someone who has both set up and managed clinical research sites, it provides practical insight into how to manage and conduct clinical research trials, and is a valuable book for both clinical site personnel and pharmaceutical/biotech company personnel. The book is easy to read, practical and uses relevant anecdotes to make key points. It also discusses issues that are important to establishing effective working relationships between contract research sites and the companies that employ them.

Overall, this book is destined to become a standard text in introducing and training anyone involved in the management of clinical research.