Patients

What is Clinical Research?

Clinical Research involves the introduction of a new investigational product into humans and the subsequent studies conducted to evaluate the efficacy of that product. All Food and Drug Administration (FDA) approved medicines, from pain killer to antibiotics, have to undergo extensive research and testing before they reach the public health systems.

It is at the final stages of this research that volunteers are needed from the community to participate in these trials.

In clinical trials, investigational drugs are often compared with approved drugs or placebo (inactive pill, liquid, or powder) to assess safety and effectiveness. Clinical trial participants may be assigned to take:

• Investigational drugs
• Approved drugs
• Placebo
• A combination of these drugs

Eligibility

There are certain requirements which must be met to be eligible to participate in a clinical trial. These requirements are based on such factors as age, gender, the type and stage of a disease, previous and current treatments, and other medical conditions. Medical insurance is not required to participate in clinical trials or to receive study-related medical care and services.

Phases of Clinical Trials

Clinical Trials are divided into 4 phases:

• Phase 1: Researchers test an investigational drug for the first time in humans by giving it to a small number of healthy people to evaluate its safety, determine a safe dosage range, and identify side effects.
• Phase 2: The investigational drug is given to a larger number of people who have a particular disease or condition, to determine its effectiveness and to further evaluate its safety.
• Phase 3: Several hundred to several thousand people with the appropriate disease or condition participate in these trials. The investigational drug undergoes additional testing to further determine its safety and effectiveness, monitor side effects, and compare it to commonly used treatments.
• Phase 4: After a drug is available by prescription, additional information is gathered to assess the drug’s risks, benefits, and use.

Trial Participation

If you are eligible and decide to participate, an informed consent document will be presented to you. This document includes information about the clinical trial and what you can expect as a participant, as well as potential benefits and possible risks associated with the research.

You should take your time and read carefully through the informed consent document. When you are satisfied that all of your questions have been answered, you will be asked to sign the document.

As an OCR study participant, you may be asked to:

• Take investigational drugs as directed
• Come in for office visits
• Have laboratory and diagnostic tests

OCR study participants may also receive at NO COST, study-related:

• Medical care
• Investigational drugs
• Laboratory services

Common misconceptions of research

• Research does not replace your primary physician care
• Research is voluntary – you may withdraw at any time
• Health insurance is NOT necessary for clinical trial participation nor does research bill or involve your insurance company in any way.

Research conducted today benefits generations to come!

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