Clinical-Trials Books

The need for writing and implementing effective SOPs in a whole spectrum of fields is on an exponential rise. Unfortuntely, there aren't many SOP books available in the market. This book by Celine Clive is one of a very few fine books on SOPs. It provides quite a few ready to go SOP templates in the clinical field. The templates seem to be consistent with the International standards. The List of SOPs covered include Spnosor/monitor/CRO SOPs, Investigational site SOPs, and Institutional Rebiew Board SOPs. The book also includes some useful forms in the clinical industy. One thing that may concern the reader is that the book is priced very high.
Again, the book is focussed on the clinical industry. If you want a book to learn the basics of writing and implementing effective SOPs that could be applied to any field, begin with the following book:

SOP Workshop: Workshop in a Book on Standard Operating Procedures for Biotechnology, Health Science, and Other Industries
If you are a beginner in the field of SOPs, this book by Dr. Paul Sanghera is your book. It explains the basic SOP concepts from scratch and offers simple examples, exercises, and templates. It's a general book on SOPs that can be used by any reader in any field. It's a good starting point for any professional in any field who wants to start with writing and implementing effective SOPs. Topics covered include: Introduction to SOPs *Effective SOPs *Producing Effective SOPs *Living with Approved SOPs: following, monitoring, and controlling SOPs *Process Based Approach to SOPs *Solutions to Self Test Exercises * Example SOP Templates *Glossary of terms. I specifically like the process based approach to SOPs: very innovative and useful approach. The price is right.

After this book, you can use the book by Celine Clive reviewed above if you are in the clinical field. There is also another good book on SOPs reviewed below:

SOP Guidelines
This book by D.H. Shah covers SOPs in quite a few areas including Production, Quality Control, Quality Assurance, Stores, Engineering, Maintenance and Housekeeping. It also contains SOP templates in these fields. A good collection of SOPs on Tablets & Capsules, Ointments, Quality Control, Liquid Orals, and Sterile Preparations. The book is highly priced, but useful.

great book. easy to follow and easy reading. i am a long time oncology nurse but brand new to research. this manual takes through the steps and provides references and web sites for additional information.

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Every year the pharmaceutical industry produces new medicines - but are they safe? One of the best ways a consumer can find out more about how such new drugs are tested and presented is by reading THE NEW MEDICINES: HOW DRUGS ARE CREATED, APPROVED, MARKETED AND SOLD, by biomedical researcher and teacher Bernice Schacter. Chapters provide historical and business background around major new drugs which have been controversial news topics, analyze the FDA's processes, and survey new marketing techniques aimed at consumers rather than physicians. From product launches to unknown factors in drug interactions, THE NEW MEDICINES provides an excellent historical overview.

The Physician Investigator Handbook, by Deborah Rosenbaum and Fred O. Smith, is an excellent book for every physician who conducts, or who has ever considered conducting, clinical trials. The book contains practical and useful information about the conduct of clinical trials from the physician's perspective. Physicians will learn, in a clear and concise format, about the facilities and staff required, the investigator's role, compliance with regulations, and how to prepare study budgets and work with the study sponsor and its representatives. This book is an excellent guide to help physicians decide whether to enter the lucrative world of clinical trials. Furthermore, it can save time and money for novice and experienced investigators alike. I highly recommend this book for all physician investigators involved in the conduct of clinical trials. The authors write from experience and pack the book with useful information. What a great investment!

This book gives a good knowledge about drug development, Clinical data management. I suggest this book for budding pharmacists who want to be a clinical pharmacist. I have gone a lot of books and find this is best for Clinical Data Management.

As a biomedical researcher and clinician, I rely on published literature to guide my practice and thought. Current medical literature is very statistically based. Consequently, I found the author's history of the rise of satistics in medicine fascinating. I can't recall seeing this material covered elsewhere. Further, this book is very thoroughly researched and anotated. The most important thing I learned from this book is that the much touted randomized clinical trial is a very recent invention.

This guide is one of the best resources a study coordinator can have. There is so much infomration that one must know in order to perform these duties and it's always changing,having this great form of guidance is just what ever research practice needs. Meeting Carol Fedor was the icing on the cake in this find!

Statistical Aspects Of The Design And Analysis Of Clinical Trials Revised edition by Brian S. Everitt, Andrew Pickles (Imperial College Press: World Scientific) About 8000 clinical trials are undertaken annually in all areas of medicine, from the treatment of acne to the prevention of cancer. Correct interpretation of the data from such trials depends largely on adequate design and on performing the appropriate statistical analyses. In this book, the statistical aspects of both the design and analysis of trials are described, with particular emphasis on recently developed methods of analysis.
According to Sir David Cox, the randomized controlled clinical trial is perhaps the outstanding contribution of statistics to 20th century medical research. Nowadays about 8000 such trials are undertaken annually in all areas of medicine from the treatment of acne to the prevention of cancer. Although the vast majority of these trials take place away from the glare of public interest, some deal with issues that are controversial enough to make even the popular press; an obvious example is the use of AZT for the treatment of AIDS.
There are many excellent books available which give comprehensive accounts of how clinical trials should be carried out and organized. The aim of this book is different; the authors attempt to give relatively concise descriptions of the more statistical aspects of the design and analysis of clinical trials, particularly those methods developed over the last decade or so. Topics discussed in this text include randomization, interim analyses, sample size determination, the analysis of longitudinal data, Bayesian methods, survival analysis and meta-analysis. Many examples are included alongside some of the necessary technical material, the more difficult parts of which are confined to tables. An Appendix gives details of relevant software. The book should be useful to medical statisticians and others faced with the often difficult problems of designing and analyzing clinical trials.
The controlled clinical trial has become one of the most important tools in medical research and investigators planning to undertake such a trial have no shortage of excellent books to which to turn for advice and information. But unlike the many other books dealing with clinical trials, this text is primarily concerned with the statistical issues of certain aspects of their design (Chapters 2 and 3) and, in particular, their analysis (Chapters 4 to 10), rather than their day-to-day organization. This restriction will enable us to give fuller accounts of some recently developed methods that may be particularly useful for the type of data often generated from clinical trials. Some details of the software available that implements the methods described will be given in the Appendix.

This book is an extremely well written and well organized discussion covering what makes a good paper ... good. It is not a mathematical statistics text. Instead it covers the methodological issues critical for good clinical research. The chapters cover: how control subjects are selected, who was not included, the size of the effects (as opposed to the p-values), collaborative data from other studies and meta analysis. The one "statistics" chapter has the best short coverage I have read on p-values, type I and II errors, confidence intervals, odds ratios/relative risks, survival analysis, prevalence and incidence. Finally there is a very brief but exceptionally useful chapter on searching for medical articles using tools beyond to the common ones like PubMed.

One standout feature of this book is the authors use of illustrative clinical examples. Every main topic is supported by references, with brief summaries of interesting research articles. The organization allows these examples to flow nicely and to reinforce the author's points.

Another great feature is the use of summary sections that can be turned into checklists for reviewing articles.

If you are looking for a book on how to evaluate the methodological issues in research get this.