Better Health Clinical Trials



			WHAT IS A CLINICAL TRIAL? A clinical trial is a medical research study to determine the safety and effectiveness of a drug or treatment and discover any side effects. Clinical trials use humans; pre-clinical trials use animals. The drug or treatment under study in the clinical trial may be: new and never been tested on people before an existing one being used in a new way In some clinical trials, a new drug or treatment may be compared with the best-known standard therapy to see if it is more effective or causes fewer side effects. Information from clinical trials: helps regulatory authorities around the world decide whether to approve a drug for use in their country guides health professionals in their decisions about prescribing drugs or other treatments to patients assists consumers with the proper use of over-the-counter and prescription medications Clinical Trial Information About Phase I Trials Phase I studies are conducted with healthy clinical trial volunteers to determine a drug's basic safety and how it affects the body. What is a healthy clinical trial volunteer? A healthy clinical trial volunteer is an adult without any significant or pre-existing health problems. Healthy volunteers contribute: essential information about how the medication is absorbed, distributed, and excreted by the body help in determining initial dosage levels for patient volunteers Why volunteer for a clinical trial? Although healthy volunteers rarely receive any therapeutic benefit from participating in clinical studies, many find it to be a rewarding experience for the following reasons: free comprehensive physical exam financial compensation new medical knowledge personal satisfaction Phase I trials are not typically conducted at Better Health Clinical Research, as they often require overnight stays and require around-the-clock monitoring, and we do not presently have the facilities or staff needed for Phase I studies. Phase II-IIIb Trials: "Patient" Volunteer Studies Patient volunteers in Phase II – IIIB studies have the condition the new drug is intended to treat. These studies are called “patient studies.” These differ from Phase I studies, which are generally conducted in healthy volunteers. A patient volunteer is an adult with a known underlying medical condition. Patient participation in trials in Phase II, Phase III, and Phase IIIB helps determine: effectiveness of the medication against the disease doses required to achieve these effects potential side effects of the medication Although patient volunteers may or may not receive any therapeutic benefit from research participation, they will usually receive financial compensation for their time and travel Phase IV Trials: “Post-marketing Trials” Phase IV trials are studies conducted on medications which have already been approved by the Food and Drug Administration and are already being marketed in the U.S. Like Phase II – IIIb trials, Phase IV trials involve volunteers who have the medical condition the drug is intended to treat. Phase IV trials are usually done to compare the study medication with other established treatments to try to demonstrate that the new medication is safer or more effective or has fewer side effects than other medications for the same condition. .
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