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What is a clinical trial?
It is a clinical research study to confirm the effectiveness and safety of new treatments that were  verified in animals and on human cells. Also, clinical trials are designed to answer specific questions about vaccines, new therapies or new ways of using known treatments. Moreover, medical groups conducting the clinical trials are reviewed and approved by government agencies before their initiations. For example, a pharmaceutical company provides its data to the Food and Drug Administration (FDA), requesting approval to begin testing its drug in humans. This is called an Investigational New Drug application (IND). 
 

Why participate in a clinical trial?
If specialists cannot help you, clinical trials is an option which allow you to gain access to new research treatments before they are widely available. Also, your participation will  help others suffering from same medical condition.
 

How are new treatments tested in humans?
Once the FDA grant a New Drug Approval (NDA), companies typically will initiate testing in three phases and some times may add a phase four study. Each successive phase involve a larger number of people. 
 

What are the phases of clinical trials?
Clinical trials are performed in phases. Each phase have a different purpose and retrieved study information will help scientists to answer specific questions:

Phase I Study:
Phase I studies focus on the drug's safety which were tested and verified in animals. Typically, the phase of testing in humans is performed  in a small number of healthy volunteers (under 100), who are usually paid for participating in the study. The objectives of this study are  to evaluate what happens to the medicine in a human body: Its absorption, metabolism and even its excretion. Also, the  phase I study will investigate side effects that may occur when dosage levels are increased. Typically a phase 1 study takes about 6 months and about 70 percent of tested experimental drugs pass this phase.. 

Phase II Study: 
This phase is focused on the effectiveness of treatment or a drug. Usually, it may take from a few  months to about two years and will involve larger number of patients (several hundreds). Typically,  phase II studies are random and blind clinical trials. This means one group of patients will receive the experimental medicine (drug), while a second "control" group will receive a standard treatment or placebo. Neither the patients nor the researchers know who is receiving the experimental treatment. This way, the study group can provide the company and the FDA valuable, non biased and comparative information about the safety as well as the effectiveness of the new treatment. Usually,  about 30% of new treatment successfully pass both phase I and phase II studies. 
 

Phase III Study: 
Having proven the safety and effectiveness of the new treatment, a phase III study will focus on testing a larger number of people (hundreds to several thousand patients). This is a large-scale testing which provide the company and the FDA with a more detailed information about the drug's effectiveness, its benefits, and the range of possible adverse or side effects. Typically,  phase III studies are random and blind clinical trials. 

Clearly, phase III studies are more extensive and they may last several years. Also, over 70% of treatments (drugs) that reach a phase III studies successfully, they are likely to successfully complete this phase of testing. At this point, a company can request FDA approval for marketing the treatment or drug. 
 

Late Phase III/Phase IV Studies:
In late phase III/phase IV studies, companies may focus on other goals such as: risks, benefits, optimal use of the drug, the  comparison with other treatments for drugs already in the market... etc.
 

Who pays for clinical trials?
Clinical trials are funded by many sources such as organizations or individuals (physicians), medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.
 

What is a protocol? 
It is a study plan required for all clinical trials. The protocol is carefully designed to safeguard the health of the participants as well as to answer specific research questions. Typically, a protocol would include the following criteria:

• Describes what types of people may participate in the trial
• Specifies the schedule of tests, procedures, medications, and dosages; and the length of the study. 
• While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

What is a placebo? 
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment. 

What is a control or control group?
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo. 

What are the different types of clinical trials?
Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.

Screening trials test the best way to detect certain diseases or health conditions. 

Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
 

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