Understanding clinical research / editors, Renato D. Lopes, Robert A. Harrington.

Format:

Book

Contributor:

Lopes, Renato D.

Harrington, Robert A.

Language:

English

Subjects (All):

Clinical trials.

Clinical medicine--Research.

Clinical medicine.

Biomedical Research.

Clinical Trials as Topic.

Research Design.

Medical Subjects:

Biomedical Research.

Clinical Trials as Topic.

Research Design.

Physical Description:

xvi, 245 pages : illustrations ; 23 cm

Place of Publication:

New York : McGraw-Hill Medical, [2013]

Summary:

Ideal for Both Researchers and Healthcare Providers, Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials-from study design and statistics to regulatory oversight-and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples-drawn from the authors' broad experience-that put chapter concepts into action and contribute to a working knowledge of integral research techniques. Features: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes. In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education, Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations, Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies, Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials Book jacket.

Contents:

A brief history of clinical trials, drug regulations, and the Food and Drug Administration / Nidhi Tripathy ... [et al.]

Information technology, access, clinicaltrials.gov / Anjan Chakrabarti and C. Michael Gibson

The role of academic research organizations in clinical research / Craig J. Reist ... [et al.]

Ethics of clinical research : an overview and emerging issues / Yee Weng Wong and Kevin A. Schulman

Introduction to clinical experimentation / Robert Bigelow

Phase I trials : first in human / Kevin M. Watt, Karen Chiswell, and Michael Cohen-Wolkoweiz

Phase II clinical trials / Jeffrey T. Guptill and Karen Chiswell

Phase III and IV clinical trials / Gail E. Hafley, Sergio Leonardi, and Karen S. Pieper

Challenges of clinical trials in pediatrics / Kevin N. Turner and P. Brian Smith

Observational research / Michaela Dinan

Data resources / Ying Xian

Observational study designs / Bradley G. Hammill

Challenges of observational designs / David M. Vock

Specific regression techniques / Phillip J. Schulte

Analytical methods of addressing confounding / Eric M. Reyes

Lessons from notable examples in observational research / Zubin Eapen and Lesley H. Curtis.

Notes:

Includes bibliographical references and index.

ISBN:

9780071746786

0071746781

OCLC:

820787881

Online:

Publisher description