HOW CLINICAL TRIALS WORK
Clinical trials measure if new therapies of a new medication are better than the best treatments we have today. The treatments medications currently used were carefully evaluated in clinical trials before being approved for widespread use.
WHO CAN PARTICIPATE
Clinical trials are open to participants from all backgrounds and stages in life. The more diverse the participant population is during the trial; the more researchers will understand how the population at large will respond to the treatment once it is on the market.
INCLUSION/EXCLUSION CRITERIA
People interested in participating in one of our clinical trials are screened to make sure that the trial is right and safe for their specific health needs. Making sure that participants meet the criteria of the trial guarantees that the data produced from the trial is meaningful.
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WHEN TO PARTICIPATE
You should consider all of your options from the beginning. See what trials are being offered and decide if one of them might be right for you. Some clinical trials are specifically designed to study participants who have not received any treatments yet, so some clinical trials are designed to be "first line" treatment.
TRIAL PHASES
It can take several years of research before a new treatment or intervention will be available for the general population. First clinical trials are conducted in multiple steps - or phases.
PHASE I
IS IT SAFE?
PHASE I: IS IT SAFE?
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A small group of people with the disorder being studied begin treatment with the investigational medication or therapy.
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A dosage of medication is created by the researchers.
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Side effects are monitored.
PHASE II
DOES IT WORK
PHASE II: DOES IT WORK?
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Several hundred people with the disease or condition are being treated.
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Any effects on disease or condition are tracked.
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Medication dosing is fine-tuned.
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Side effects are documented.
Some medications and treatments are approved based in Phase II Trials
PHASE III
IS IT BETTER?
PHASE III: IS IT BETTER?
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Involves several hundred to several thousand participants.
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Investigational treatment is compared to the current quality of care provided.
PHASE IV
HOW IS IT DOING?
PHASE IV: HOW IS IT DOING?
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Evaluates long-term side effects, safety issues, and any unexpected benefits
HOW CLINICAL TRIALS ARE ORGANIZED
Clinical trials are designed to produce data and information. Researchers must be able to demonstrate the benefits seen in the trial is a direct result of the treatment being studied.
They must also be able to determine if there are any side effects caused by the new treatment, to do this, they need people affected by the condition that they are researching.
QUALITY OF CARE
The World Health Organization defines Quality of Care as: "the degree to which health services for individuals and populations increase the likelihood of desired health outcomes."
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Clinical trials are vital to discovering new treatments that are better than the existing quality of care provide and to create better quality of care that is not currently available.
RANDOMIZED CONTROLLED TRIALS
One of the many ways that researchers can isolate the results of of a clinical trial is through a process called randomized controlled trials. This is helpful when comparing the investigational treatment to the quality-of-care principle.
Participants are randomly assigned to either the “investigational group” that receives the new therapy or a “control group” that receives a placebo. Randomly assigning participants helps to create two similar groups for comparison.
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PLACEBOS
People are sometimes concerned that if they enroll in a clinical trial, they might receive a placebo (inactive treatment). If you are considering participation in a clinical trial, you will be told whether it involves use of a placebo.
"Clinical trials offer two main benefits for participants:
1. A very comprehensive evaluation where you can get EKGs, diagnostic labs, assessments and a diagnosis (if needed) at no cost to the participants.
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2. They are vital to the advancement of healthcare; all of the treatments that are currently being used were once a part of a clinical trial. "
Dr. Elias H. Sarkis
Sarkis Family Psychiatry and Sarkis Clinical Trials Founder
TAKE THE NEXT STEP: FIND A TRIAL
There are several ways to search and find a trial. You can call one of numbers to speak with a Sarkis Clinical Trials representative or fill out a form and someone will be in contact with you.