Welcome to Juno Research Patient Resources page. On this page you will find valuable information regarding the process of drug development, the importance that volunteer patients play on this process and some of the benefits that a volunteer receives for participating in clinical trials. The process of drug development consists of (5) main Phases: Pre-clinical Phase, Phase I, Phase II, Phase III, and Phase IV.
This is the stage in which extensive laboratory research is conducted and the product or compound extensively tested in animals and human cells. This is a complicated process that takes several years of study and experimentation. Before any drug is used in humans, the pharmaceutical companies have to submit an application to the Food and Drug Administration (FDA), for evaluation and permission to begin testing in humans. The FDA then evaluates all the data collected and submitted by the pharmaceutical company and determines if the new-drug benefits outweigh the risks. Based on the results of this evaluation, they either grant or deny the petition to start human testing.
Phase One ( I ) :
This phase mainly assess the safety of the new drug and investigates its side effects. It is the first time that the drug is tested in human subjects. It could last from a few weeks to several months. It is intended to determine what happens to the drug in the human body, how it is absorbed, metabolized, and excreted. This initial phase of human testing involves a limited number of healthy volunteers that usually ranges from 20 to 200 patients.
Phase Two ( II ) :
After it has been determined that the drug is safe, it is tested for efficacy on phase II trials. These trials may last from several months to a few years and involve several hundred volunteer patients that match specific criteria. Patients participating in phase II clinical studies are usually randomized to different treatments or arms. These arm treatments include the investigational drug, placebo or inactive drug, and other already-FDA-approved drugs to compare the effectiveness of the new drug. These studies are often “blinded”, meaning that neither the patients nor the research personnel will know to which arm treatment the patient have been assigned to.
Phase Three ( III ) :
Phase III clinical studies usually involves several thousand patients.These trials usually last from one to five years and are intended to further all knowledge of drug safety, effectiveness, side effects, and benefits in large scale populations. These trials use “randomized” and “blinded” parameters. After the trial is over and all information collected and analyzed, the pharmaceutical companies can then request approval from the FDA to market the drug.
Phase Four ( IV ) :
Phase IV studies are post-marketing studies. In most cases the drug has already been approved by the FDA and is available in most pharmacies. These trials may last several months and usually involve thousands of volunteers. They are used to further all knowledge of the drug, compare it to other drugs, and assess its long-term impact in the patient’s quality of life.
Patients volunteer all over the world to participate in clinical trials. They play a vital roll in the process of drug development, they are the real heroes of the process, they are the ones that make the difference and take that extra-step to go forward. All the medications that we find so readily today in the market are there thanks to millions of volunteers that successfully completed clinical trials to better the world of other people. Other people that like them, were suffering from conditions that were taking a toll in their quality of life.
There are many benefits that volunteers receive while participating in a clinical study. Patients participating in clinical studies receive all study-related doctor visits, laboratory evaluations and study medications at no charge for them. The Investigators are constantly checking on their condition and evaluating if the study is right for them, providing them with first class medical care, and most clinical studies offer monetary compensation for time and travel. Another benefit a volunteer receives from participating in a clinical study is the knowledge that their participation today may save and/or increase the quality of life of countless people in the
future, including those close to them.
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