Clinical Trials Summary Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available. Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women. An Institutional Review Board (IRB) reviews, monitors, and approves many clinical trials. It is an independent committee of physicians, statisticians, and members of the community. Its role is to Make sure that the study is ethical Protect the rights and welfare of the participants Make sure that the risks are reasonable when compared to the potential benefits In the United States, a clinical trial must have an IRB if it is studying a drug, biological product, or medical device that the Food and Drug Administration (FDA) regulates, or it is funded or carried out by the federal government. NIH: National Institutes of Health Array A guide to clinical trials for cancer Specifics Access to Investigational Drugs National Cancer Institute Are Clinical Studies for You? National Institutes of Health, Clinical Center Clinical Trials – Participants National Institute of Mental Health Participating in Alzheimer’s Research: For Yourself and Future Generations National Institute on Aging Participating in Alzheimer’s Research: Why Placebos Are Important National Institute on Aging Volunteer Stories National Institutes of Health Start Here Be a Partner in Clinical Research National Institutes of Health Clinical Trial Basics National Institutes of Health Clinical Trials National Heart, Lung, and Blood Institute Frequently Asked Questions about Clinical Research National Human Genome Research Institute Learn about Clinical Studies National Institutes of Health NIH Clinical Research Trials and You National Institutes of Health Videos and Tutorials Children and Clinical Studies: Why Clinical Studies Are Important National Heart, Lung, and Blood Institute NIH MedlinePlus Magazine Children Research Volunteers Receive Care and Help Advance Knowledge Clinical Trial Results Vary Widely, but Always Advance Research Clinical Trials: A Crucial Key to Human Health Research Clinical Trials: Key to Medical Progress ClinicalTrials.gov Turns 10! Cokie Roberts Cares about Kids! Developing Safe and Effective Medicines for Children Importance of Children in Clinical Trials Importance of Clinical Trials Value of Medical Research Volunteering for Clinical Trials Can Help Improve Health Care for Everyone What Are Clinical Trials? Patient Handouts Clinical Trials Food and Drug Administration Seniors Clinical Trials and Older People National Institute on Aging Participating in Clinical Trials National Library of Medicine Related Issues Clinical Trials Shed Light on Minority Health Food and Drug Administration How Do Clinical Trials Work? National Heart, Lung, and Blood Institute Informed Consent (Clinical Trials) National Cancer Institute Placebo Effect American Academy of Neurology Understanding Risk: What Do Those Headlines Really Mean? National Institutes of Health What Are the Possible Benefits and Risks of Clinical Trials? National Heart, Lung, and Blood Institute What Else Should I Know about Clinical Research? National Institute of Child Health and Human Development Find an Expert ClinicalTrials.gov Background Information National Institutes of Health ClinicalTrials.gov: Search Clinical Trials National Institutes of Health National Institutes of Health National Institutes of Health Reference Desk Glossary of Clinical Trials Terms National Institutes of Health Statistics and Research National Institutes of Health Clinical Alerts and Advisories National Library of Medicine Journal Articles Clinical Trials
