The following are common words you will see and need to understand when researching clinical trials.

• Protocol
• Placebo
• Control Groups
• Open Label Study
• Blind Study
• Double-blind study
• Informed Consent
• The Informed Consent Form
• Compassionate Use

In an Open Label Study, all of the individuals involved (the patient participant, doctor and/or study coordinator) are advised of the drug and dosage that is being administered. All patients are given the treatment being studied, meaning that there is no use of placebo . These studies are generally conducted in Phase I or Phase II  of a clinical trial.(For information about the various phases of a clinical trial, clickc  here)

All clinical trials are based on a set of rules called a protocol. A protocol includes:

• What types of people may and may not participate in the trial
• The schedule of tests, procedures, medications and dosages
• The proposed length of the study

A Placebo is a substance that looks like the drug being tested but which has NO medication in it. If the trial medication is a pill, so is the placebo. If it is a shot, so is the placebo.

Placebos are sometimes called “sugar pills.”

Placebos are used to help determine if an experimental medication works. Some people get the medication, other people get a placebo. The results are then compared to find out if the medication being studied produces a better effect than the generic version. 

A control group is the standard by which experimental observations are
evaluated and measured. For example, one group of patients in a trial is given the experimental treatment to be studied. The other group (control group) is given a proven treatment or placebo. Because the results of the group given the proven treatment or placebo can be predicted, they are considered to be the control group.

In this type of study, the participants do not know if they are in the experimental or control group of a study. Those in the experimental group receive the drug or treatment that is being tested. The members of the control group receive a standard (proven) treatment or no treatment at all.

In this type of study neither the participants nor those conducting the study know which group is receiving the experimental treatment and which group is receiving the standard (proven) treatment or placebo. These studies are designed so that the expectations of the participants or researchers do not influence the treatment outcome.

Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate.
           
The research staff will provide you with informed consent documents that include the details about a study.  If English is not your first language, you can ask for the consent in another language. 

Since joining a clinical trial is an important decision, it is important to ask the research team any questions you may have about the study or the consent forms, before making a decision. 

You should understand that informed consent is more than simply signing a form.  It is a process that continues through the study. You should feel free to ask the research team questions before, during, and after the study.

The informed consent form should include provisions to the effect that:

• The study involves research, including a statement about the purpose of the research.
• A description of the trial, including the length of time, the research procedures that will be used, and description of any procedure that are considered to be experimental.
• A description of the possible risks and benefits to participants.
• A description of your options for treating your condition if you do not participate in the trial.
• An Institutional Review Board will oversee the study.
• You will be warned of known potential risks and side effects.
• You will be informed right away of any adverse findings that appear during the course of the trial that would cause a prudent person to consider discontinuing the trial.
• You have a right to drop out of the study at any time, with no cost to you.
• If you will receive compensation, a description of the amount and when you will be paid.
• All information concerning you individually will be kept confidential.
• Who pays for expenses if you are injured in a trial.
• You do not give up a right to sue in the event of injury.
• A description of your rights as a participant in the trial.
• Contact information in case you have questions about the research, your rights and who to contact in the event of a research-related injury. 

If there are major changes to the trial, you will be given a new Informed Consent form to sign. Review it as carefully as the original.

Your copy of the Informed Consent Agreement should be stored in a safe place for future reference. 

One of the objectives of the FDA is to make drugs available in a shorter amount of time, while still focusing on the protection and safety of study participants. These measures include:

Drug Categorization: In order to speed the drug review process, the FDA now categorizes drugs as:

1. Standard Drugs: Drugs which provide only minimal or no improvement over drugs already available on the market.
2. Priority Drugs: Drugs which may provide a major advancement in treatment. Priority drugs include drugs that are already in existence, but where treatment improvement may be made by providing a new dosage form or a new use of the drug.

Treatment Investigational New Drugs (IND): Treatment IND's fall under the FDA's "expanded access" program. The purpose of these various expanded access programs is to provide availability of a drug to a greater number of people, as early as possible during the clinical trial process. The drugs are administered to those patients who are not eligible to be in the definitive clinical trials, which are typically in Phase III studies.

In order for a drug to qualify for the expanded access program, it must have already shown promise in its effectiveness, and the intended use must be treatment of a serious or life-threatening condition. The drugs may also be administered when there is no comparable alternative drug or therapy available to treat a specific stage of a life-threatening disease.

Probably the most well known use of a Treatment IND, is AZT, an anti-viral medication used to treat people with HIV/AIDS. During the AZT Phase II trial, which included about 300 participants, it was noted that 19 patients receiving a placebo had died. Only 1 death was recorded for those participants receiving AZT. Within one week, placebo the FDA authorized a new treatment protocol for AZT. As a result, 4,000 people were treated with the drug before its approval.

To date the FDA has approved more than 40 drugs for the Treatment IND program. These drugs have been primarily used in the treatment of HIV/AIDS and cancer.