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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.

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.

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"Testimonial of trial participant”

Participant's name

Name of Trial

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?

  • A small group of people with the disorder being studied begin treatment with the investigational medication or therapy.

  • A dosage of medication is created by the researchers.

  • Side effects are monitored. 

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PHASE II

DOES IT WORK

PHASE II: DOES IT WORK?

  • Several hundred people with the disease or condition are being treated. 

  • Any effects on disease or condition are tracked. 

  • Medication dosing is fine-tuned. 

  • Side effects are documented.

 

Some medications and treatments are approved based in Phase II Trials

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PHASE III

IS IT BETTER?

PHASE III: IS IT BETTER?

  • Involves several hundred to several thousand participants. 

  • Investigational treatment is compared to the current quality of care provided. 

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PHASE IV

HOW IS IT DOING?

PHASE IV: HOW IS IT DOING?

  • Evaluates long-term side effects, safety issues, and any unexpected benefits

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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."

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.

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.

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"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.

and

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

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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.

FIND A TRIAL

Fill out the short online questionnaire to determine which of our clinical trials fit your specific diagnosis.

We can also update you when a new study will be opening that matches the information you have provided.

CONTACT US

Gainesville, Florida Office:

352- 334-0094

Ocala, Florida Office:

352-363-5395

Monday - Friday 

8:00 am - 5:00 pm ET

FIND A CLINICAL TRIAL

By submitting this form, you grant permission for Sarkis Clinical Trials to contact you. Sarkis Clinical Trials will not sell or share your information.

Please do not submit another person’s name or email without their consent.

Thanks! A member of our staff will contact you.

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