Patient Resources

On this page you will find valuable information regarding the process of drug development, the importance that volunterring for a clinical trial plays in the process of drug development, the benefits of participating in a clinical trial as well as the opportunity to apply for current or upcoming trials being conducted by Juno Research.

For general information about participating in clinical trials, please visit the following:

Useful Web Sites
www.clinicaltrials.gov
www.fda.gov/Drugs

PATIENT "VOLUNTEER" ROLE

Patients volunteer in all parts of the world for participation in clinical trials. They play a vital role in the process of drug development and are the "hero's" of the program. Patient volunteers make the difference and take the extra-step needed to move forward in curing disease. All of the medications we use today are thanks to millions of volunteers that sucessfully completed clinical trials.

BENEFITS:

Patients participating in clinial studies receive all study-related doctor visits, laboratory evaluations and study medications at no cost. Investigators are constantly revieiwng their condition and evalutating if they are right for the studing and providing first class medical care. Most clinical studies offer monetary compensation for time and travel.

PARTICIPATION:

Numerous clinical trials are developed each year. Juno Research is always looking for patients with the following conditions: Diabetes, High Cholesterol, High Blood Pressure, Asthma, Allergies, Acute and Chronic Bronchitis, Arthritis, Sexual Dysfunction, Hepatitis, urinary Incontinency, Overactive Bladder, Insomnia, Depression, Obesity, Lower Back Pain, Migraines, Angina, Peripheral Vascular Disease, GERD, Thyroid Problems and Chronic Anemia.

If you would like to partipate in a clinical trial, please contact us at:

(713) 779-5494

or by email:

patients@junoresearch.us

One of our recruitment representatives will answer any questions you may have and offer more information about the trials currently enrolling.

THE PROCESS OF DRUG DEVELOPMENT

The process of drug development consists of five main phases: Pre-Clinical, Phase I, Phase II, Phase III and Phase IV.

Pre-Clinical:

This pre-clinical stage is where extensive laboratory research is conducted and the product or compound is extensively tested in animals and human cells. This is a complicated procecss that takes several years of study and experimentation. Before a drug compound can be tested on human subjects, the pharmaceutical company must submit an application to the Food and Drug Administration (FDA) for evaluation and permission to begin testing. The FDA will then evaluate all of the data collected during the pre-clinical phase and determine if the new drugs benefits outweigh the risks. Based on the results of this review, the FDA then either grands or denies the application to begin human trials.

Phase I:

This phase mainly assesses the safety of the new drug and investigates any possible side effects. This phase marks the first time that the compound is tested on human subjects. Phase I can last from a few weeks, to several months. Phase I is intended to determine what happens to the drug once inside the human body: How it is abosrbed, metabolized and excreted. This initial phase of human testing involves a limited number of healthy volunteers, usually between 20 - 200 patients.

Phase II:

After determining that a drug is safe, it is tested of efficacy during Phase II. These trials can last from several months to several years and can involve hundreds of patients. Patients participating in phase II clinical trials are usually randomized into different treatments or "arms". These arm treatments include the investigational drug, placebo or inactive drug and other approved drugs, and will comare the effectiveness of the new compound being tested. These studies are often "blinded", meaning that neither the patient nor the research personnel have knowledge as to which arm of treatment the patient is assigned.

Phase III:

Phase III clinical studies usually involve 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 complete and all of the information is collected and analyzed, the pharmaceutical company can then request approval from the FDA to market the drug.

Phase IV:

Phase IV studies are post-marketing studies. In most cases the drug has 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 the long term impact on the patient's quality of life.