The ILLUMINATE Program

Questions

What is a clinical research study?

Clinical research studies try to answer specific questions about investigational study drugs. A new medication must go through several phases of clinical research to evaluate its safety and effectiveness.

Are clinical research studies safe?

Clinical research studies are conducted in a healthcare setting (a hospital or clinic) and are typically monitored by a trained healthcare professional. An Institutional Review Board or Ethics Committee approves all clinical research studies. This is a committee made up of doctors, ethicists, and members of the general public and administrators. This group is held responsible for ensuring that a trial does not represent an unreasonable risk to patients who are participating. Doctors run the tests according to strict rules set by the governing bodies in each country, such as the Food and Drug Administration in the US. Your doctor is responsible for your well-being and is the best person to decide whether or not you are eligible to participate in a trial.

Why should I participate in a clinical research study?

There are many reasons people take part in clinical research studies. It gives patients a chance to access medicine not available for prescription to the public. If this is the case, remember the study is being performed to discover if the drug works and to see if it is safe. This means there is information unknown about a drug, therefore classifying it as experimental.

Often the process of collecting information in the study will allow your doctor to find out more about your disease and the effects it has on you. This may allow you to benefit from better procedure after you have completed a trial.

Lastly, a trial may not benefit you directly, but the information gathered may be of help to other patients with the same condition. Many patients derive satisfaction from knowing they are part of the effort to potentially reduce the suffering of other people.

How will I know if I am eligible for a clinical research study?

You can find out about clinical research studies from many sources. There are often advertisements in your doctor's office. Many clinical research studies are posted on internet pages such as this one and provide an excellent source of information. Each trial has certain requirements for participation. Your doctor will take a medical history from you and may request additional testing to determine if you are eligible according to the criteria for the study.

What is informed consent?

Anyone entering a clinical research study is required to sign a form indicating that they understand what will happen to them during the study. This form will tell you what procedure will be given, what kind of problems might occur, and what other treatments might work for your condition. The amount of help expected from the study will be given. In Phase I studies, it is usually not known whether any help will occur. The informed consent form also indicates which costs are covered by the study and which must be paid by you (or your insurance).

What is a PHASE in a clinical research study?

An investigational study drug must pass three phases of clinical testing before it is approved by government agencies, such as the Food and Drug Administration in the US and before it is made widely available to the public.

Phase I – the study drug is given to a small group of healthy volunteers. Researchers look to see how much study drug is safe to take and how the human body reacts when it receives the study drug.
Phase II – the study drug is given to a small group of people with the disease or illness it was intended to treat. Researchers will look at which dose works best, how safe it is, and will begin to look at the effectiveness of the study drug.
Phase III – at this stage, doctors again look to see if the study drug is safe and effective in treating a disease or illness but over a longer period of time, with a much larger group of volunteers. Sometimes the study drug is compared to approved medications that are used to treat the same condition.

The ILLUMINATE studies are Phase III studies. This means the investigational study drug has been suggested as safe and effective from previous studies. During a Phase III study, study doctors will gather additional information about the effectiveness and safety of the investigational study drug. The study has been set up following government guidelines which were approved by an independent review board/independent ethics committee.