Fundamentals of Clinical Trials

ISBN-10: 1441915850

ISBN-13: 9781441915856

Edition: 4th 2010

List price: $69.95
30 day, 100% satisfaction guarantee

If an item you ordered from TextbookRush does not meet your expectations due to an error on our part, simply fill out a return request and then return it by mail within 30 days of ordering it for a full refund of item cost.

Learn more about our returns policy

Description: The randomized control clinical trial has become the gold standard scientific method for the evaluation of pharmaceuticals, biologics, devices, procedures and diagnostic tests. This trial design has been successfully used in both therapeutic and disease prevention trials. It is superior to alternative designs by eliminating several sources of bias which exist in those designs. This role has evolved over the past three decades in a number of disease areas including cardiology, opthalmology, cancer and AIDS. While the specifics of using the randomized control design for a specific intervention and disease may differ, the basic fundamentals still apply in developing the study protocol and operational procedures. These fundamentals still apply in developing the study protocol and operational procedures. These fundamentals include identifying the specific questions to be tested and appropriate outcome measures, determining an adequate sample size, specifying the randomization procedure, detailing the intervention with visit schedules for subject evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and determining the organizational structure.This text is structured to address the fundamentals as the protocol for a clinical trial is being developed. A chapter is devoted to each of the critical areas of a protocol to aid the clinical trial researcher. The fundamentals described in this text are based on sound scientific methodology, statistical principles and years of accumulated experience by the three authors. Collectively, the authors have been active researchers in a broad area of clinical trials including cardiology, cancer, opthalmology, diabetes, osteoporosis, AIDS, women's health and screening tests. In these studies, the authors have served as members of the steering committee responsible for developing the protocol and as members of data and safety monitoring committees. The fundamentals were proposed in the first edition published in 1981 and have not changed substantially in the later editions. However, the number of examples illustrating the fundamentals has greatly expanded base on the collective experience of the authors.This text is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The test uses numerous examples of published clinical trials from a variety of medical disciples to meaningfully illustrate the fundamentals. Technical design issues such as sample size are considered but the technical details have been suppressed as much as possible through the use of graphs and tables. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful both in a consulting and teaching capacity.The text assumes that the readers have only a modest formal statistical background. A basic introductory statistics course is helpful in maximizing the benefit of the text. However, a researcher or practitioner with no statistical background would still find most, if not all the chapters understandable and useful.

what's this?
Rush Rewards U
Members Receive:
coins
coins
You have reached 400 XP and carrot coins. That is the daily max!

Study Briefs

Limited time offer: Get the first one free! (?)

All the information you need in one place! Each Study Brief is a summary of one specific subject; facts, figures, and explanations to help you learn faster.

Add to cart
Study Briefs
Periodic Table Online content $4.95 $1.99
Add to cart
Study Briefs
Calculus 1 Online content $4.95 $1.99
Add to cart
Study Briefs
Medical Terminology Online content $4.95 $1.99

Customers also bought

Loading
Loading
Loading
Loading
Loading
Loading
Loading
Loading
Loading
Loading

Book details

List price: $69.95
Edition: 4th
Copyright year: 2010
Publisher: Springer
Publication date: 9/21/2010
Binding: Paperback
Pages: 445
Size: 9.25" wide x 9.00" long x 0.75" tall
Weight: 1.782
Language: English

×
Free shipping on orders over $35*

*A minimum purchase of $35 is required. Shipping is provided via FedEx SmartPost® and FedEx Express Saver®. Average delivery time is 1 – 5 business days, but is not guaranteed in that timeframe. Also allow 1 - 2 days for processing. Free shipping is eligible only in the continental United States and excludes Hawaii, Alaska and Puerto Rico. FedEx service marks used by permission."Marketplace" orders are not eligible for free or discounted shipping.

Learn more about the TextbookRush Marketplace.

×