Understanding Clinical Research

INTRODUCTION

ETHICS IN CLINICAL RESEARCH

THE RESEARCH QUESTION

DESIGNS and TYPES OF STUDIES

STARTING THE STUDY

RECRUITMENT OF SUBJECTS

DATA MANAGEMENT

DATA ANALYSIS

CLOSE OUT

REPORTING AND INTERPRETING FINDINGS

APPENDICES

Statistics Tables

Summary of Statistical Procedures

Power and Sample size

Effect size index

Power for ANOVA

Power for Correlations

Power for Regressions

Power for chi-square

Transformation of Data

Sample Informed consent form

Glossary of terms

Glossary of statistical symbols and abbreviations

Industry Resources

Associations

Conference Organizers

Publishers

Top Sponsors

Top CROs

Performance measures

Speed

Quality

Cost

Declaration of Helsinki

FDA form 1572

Financial Disclosure form

Code of Federal Regulations

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A complete guide to understanding and applying clinical research results

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 weaknesseswith 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 theimpact 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