What is a clinical trial?
A clinical trial evaluates an investigational drug or medical device to see if it is safe and effective before it is made available for doctors to prescribe. All clinical trials are monitored by review boards to protect the safety of all participants. Governmental agencies review the results of clinical trials to decide if the investigational drug or medical device is safe and effective and should be made available to the public.
How are clinical trials monitored?
Clinical trials are typically monitored by a trained medical professional. A review board evaluates all clinical trials. This is a committee made up of doctors, ethicists, members of the general public, and administrators. This review board helps to ensure that a clinical trial does not present an unreasonable risk to individuals who are participating. Your own doctor is responsible for your well-being and you may speak with him or her to discuss a clinical trial before you decide to join. Whenever you agree to enter a clinical trial, you are given the name and telephone number of a contact in your study doctor's office who will answer your questions and explain the clinical trial.
Why do people participate in a clinical trial?
There are various reasons people take part in clinical trial. For many people, taking part in a clinical trial is important because their participation is helping to make new treatments possible. Clinical trials are the key to finding new ways to prevent, diagnose, and treat diseases.
Being in a clinical trial also gives individuals a chance to receive an investigational drug that is not available for prescription to the public. If you are interested in this, remember that the clinical trial is being performed to see if the investigational drug works and to see if it is safe.
Often the process of collecting information in the clinical trial will allow your doctor to find out more about your disease and the effects it has on you. A clinical trial may or may not benefit you directly, but the information gathered may be of help to other individuals in the future with the same condition.
How will I know if I am eligible for a clinical trial?
Each clinical trial has certain requirements for participation. Your study doctor will ask you about your medical history and do some tests to see if you are eligible for the clinical trial. Each clinical trial has strict eligibility criteria to ensure that the study is as safe as possible for each participant and to try and allow equal comparison across all participants in the study.
What is an informed consent form (ICF)?
The informed consent form (ICF) is a document that explains the clinical trial in simple language. It provides detailed information about the clinical trial, such as the purpose, eligibility requirements, what will happen during the trial, risks and benefits, and the rights of participants.
If you have any questions about the ICF, please ask your study doctor.