Lowcountry Medical Group
Beaufort SC
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Orthopedics - Nephrology - Oncology - Neurology

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Patients  Are Needed for Clinical Trials:
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Information About Clinical Trials

Researchers conduct clinical studies to evaluate the safety and effectiveness of investigational drugs

Investigational drugs that are found to be safe and effective may then become available for doctors to prescribe. If an investigational drug is determined to be unsafe or ineffective, the studty results may still be useful for scientists and for the advancement of medical research.

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

 - Investigational Drugs
- Approved Drugs
- Placebo
- A combination of these drugs

Phases of Clinical Research Studies:

Phase 1: Researchers search 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 isdentify side effects.

Phase 2: The investigational drug is given to a larger number of people who have a particular disease or condition to determine the effectiveness, and further evaluate its safety.

Phase 3: Several hundred people to several thousand people with the appropriate disease or condition participate in these studies.  The investigational drug undergoes testing to further determine its safety and effectiveness, monitor side effects, and compare it to commonly use treatments.

Phase 4: After the drug is available by prescription, , additional information is gathered to assess the drug's risks, benefits, and use.

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


Study Participation
If you are eligible and decide to participate, and informed consent document will be presented to you. This document includes information about the clinical study 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 a participant, you may be asked to:
- Take investigational drugs as directed
- Come in for office visits
- Have laboratory and diagnostic tests

Study participant may also receive at no cost, study related medical care, investigational drugs, and laboratory services.

Your Protection
A medical Ethics group will oversee the clinical study to ensure that you are being appropriately treated. If you are dissatisfied at any time, you are free to leave the study.
 
If you have any questions, please click here to email us





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