LibGuides: Clinical Trials: Learn About Clinical Trials

What is a Clinical Trial?

A clinical trial is a specific type of research study that involves human participants receiving treatments or interventions for a certain disease or condition to determine the treatment's safety and effectiveness. Clinical trials have different phases (Phase I - Phase IV) depending on the stage of the research.

Video created by the National Cancer Institute.

Government Resources

ClinicalTrials.gov - About Clinical Studies
Provided by the US National Library of Medicine, ClinicalTrials.gov answers many common questions about clinical studies, such the difference between a clinical trial and an observational study, some common reasons for conducting clinical studies, questions to ask if you are thinking about participating in a study, and a glossary of terms.
NIH Clinical Research Trials and You
Aimed at the general public, this National Institutes of Health website provides information on The Basics of clinical trials, as well as a glossary of common terms and a listing of personal stories.
MedlinePlus: Clinical Trials
MedlinePlus, a service of the National Library of Medicine and the National Institutes of Health, provides links and information about Clinical Trials.
National Cancer Institute: What Are Clinical Trials?
The Clinical Trials section of the NCI website contains an abundance of information about cancer-related clinical trials, including the different types and phases of trials, some introductory clinical trials methodology, and information on patient safety.
National Institute of Child Health & Human Development
This site's Clinical Research section contains a nice overview of clinical research, and provides users with the general principles behind NICHD clinical research. Users can also easily link to a pre-set search in ClinicalTrials.gov to locate NICHD-supported clinical trials.
National Institutes of Health Clinical Center
The National Institutes of Health (NIH) Clinical Center serves as the nation's research hospital for conducting clinical research. It also develops diagnostic and therapeutic interventions and works to improve clinical research and lead the response to public health needs. The center's site contains a wealth of information about clinical trials in general and NIH clinical studies. It also contains information aimed at helping patients start a discussion with their physicians about clinical trials.
U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) Web site contains a good deal of information about FDA-regulated clinical trials including information on clinical practice/clinical trials regulations, laws enforced by the FDA, guidance and notices about good clinical practice and the conduct of clinical trials, proposed regulations and draft guidelines, enforcement information, links to Compliance Program Guidance Manuals, and literature references and training information about good clinical practice. Users can also submit complaints related to clinical trials through the FDA Web site.
National Institute of Mental Health
The National Institute of Mental Health (NIMH) is one of the National Institutes of Health. The organization funds research by scientists across the country, as well as those in NIMH studies in their internal research program. The Clinical Trials section on the site allows users to learn more about participating in a study, referring a patient, or learning more about the results of the studies. The Information for Researchers section contains information for researchers conducting studies, limited access data sets, and more.

Other Resources

CenterWatch
CenterWatch is a company which provides proprietary data and information about clinical trials. Their Clinical Trials Overview and Patient Resources webpages contain information about clinical trials, including the different phases of human clinical trials and a clinical trials glossary.

Selected Books

Fundamentals of Clinical Trials by Lawrence M. Friedman; Curt D. Furberg; David DeMets; David M. Reboussin; Christopher B. Granger
Publication Date: 2015
This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. This book 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. **E-book - OSU patrons only**
New Drug Development: An Introduction to Clinical Trials by J. Rick Turner
Publication Date: 2010
New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug's safety and efficacy profiles, and manufacturing considerations. **E-book - OSU patrons only**
Clinical Trials: What Patients and Healthy Volunteers Need to Know by Lorna Speid
Publication Date: 2010
Every year, hundreds of thousands of healthy volunteers and patients worldwide undertake the journey through the maze that can be clinical trials. Research participants take part in clinical trials for a variety of reasons. Whatever the goals, though, most participants will experience the same sense of bewilderment as they encounter the jargon and medical terminology that they will hear and have to read about and understand during the course of the clinical trial. Clinical Trials: What Patients and Volunteers Need to Know demystifies the entire process, focusing on the process of drug development, and the clinical trial itself. **Print Book**

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What is a Clinical Trial?

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Selected Books