Clinical Trials Research Introduction

Clinical Trial Terms

Current List of SHOA Trials

Current List of TORI Trials

Clinical Trials Frequently Asked Questions

Clinical Trials: Highly-controlled research studies involving patient volunteers, that investigate emerging therapies in the hopes of answering specific scientific questions, and finding different ways to prevent and treat diseases such as cancer.

Informed Consent: The process, by which a patient learns the key facts about a clinical trial, including its benefits and risks, and then decides whether or not to voluntarily participate. For those who choose to take part, the process involves signing a form that outlines the research study's details prior to participation.

Phases: The structure of clinical trials, ranging from Phase I (small groups of trial participants who help determine the safety, dosage, and side effects of a study drug) to Phase IV (testing after the study drug has been marketed to determine its effect across diverse populations and over the long-term).

Protocol: An action plan for a clinical trial, stating the purpose and processes of the research study. The protocol includes information such as the number and types of patients participating, the nature and frequency of tests, and the study drug regimen.

Randomization: The random assignment of a clinical trial's participants to either the study drug regimen or control group in order to prevent any research bias.

Side effects: Problems that can occur along with either a current standard treatment or a research study drug that affect healthy cells. Common side effects can include fatigue, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

Standard treatment: The most current and approved treatment known for a disease, such as a specific type of cancer, based on results of past research studies.

Study drug: An investigational agent provided as part of a clinical trial/research study that is not approved by the U.S. Food and Drug Administration (FDA) for marketing and sale in the United States