What is a Clinical Trial?
A clinical trial, also called a clinical research study, is a carefully designed scientific evaluation of an investigational medication or treatment. Clinical trials are conducted by doctors and researchers. They help to answer important medical questions, such as:
- • Is the investigational medication safe?
- • How does it act in the body?
- • How does it affect certain diseases or conditions?
What are the Phases of Clinical Trials?
Clinical trials are typically grouped into four types of phases. The clinical trial phases are:
Researchers test a new drug or treatment in a small group of people for the first time to gather information on its safety, dosing, and side effects.
The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety.
The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
These studies are conducted after a drug or treatment is approved for use by regulatory authorities. Phase 4 studies gather additional information on the drug's effects and side effects.
5 Frequently asked questions about clinical trial participation
The safety of the people who volunteer is always the primary concern of everyone involved in a clinical trial. In order to provide reliable information and findings, well-controlled clinical trials require the participation of hundreds, and sometimes even thousands, of volunteers.
Before you decide whether or not to take part, you should know why the research is being done and what it involves. The study doctor, nurse, or coordinator will describe all of the possible benefits and risks of taking part in the study that are known at that time. You should ask the study doctor (or his or her staff) any questions you may have. This process is meant to help you decide whether or not participating in the study is right for you.
1) Who can participate in a clinical trial?
Each clinical trial has different requirements, also called eligibility criteria, which determine whether a person can participate.
The factors that describe who can participate in a clinical trial are called "inclusion criteria" and those that describe who cannot participate are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and help keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
2) Can a person continue to work with his/her primary physician while in a trial?
Yes. Most clinical trials provide short-term participation related to a designated illness or condition. They do not provide extended or complete primary health care.
In addition, by having the health care provider work with the clinical study team, the participant can ensure that other medications or treatments will not conflict with the protocol.
3) What Is "Informed Consent"?
If you decide that you want to participate in the study, a member of the clinical study team is required by law to review a detailed document about the study with you, called the “Informed Consent Form.” This document provides you with important information about a clinical research study and documents your agreement to participate.
The purpose of “Informed Consent” is to make sure that:
- • You understand what participating in the study will involve, including the potential side effects and other risks associated with the investigational medication or the study procedures
- • You understand your responsibilities as a study participant
- • Any questions you have about the study have been answered
- • You want to be in the study
- • You know that you can leave the study at any time
You may take an unsigned copy of this form home with you to read again or to discuss with family, friends or your personal doctor before making your decision. Even after signing the form you may withdraw from the study at any time.
4) What happens to when you decide to join a clinical trial?
The person (or participant) will sign the Informed Consent Form and will be asked to attend a screening visit with the study team. At this visit, the participant will undergo tests and evaluations (as described in the Informed Consent) to determine if that person’s condition is a good match for the study. If there is a good match, the person is allowed to enroll in the study.
During the study, the participant will be expected to visit the study doctor regularly and undergo the clinical trial procedures (as described in the Informed Consent Form). While in the trial, the clinical study team will follow your condition closely.
The clinical study team includes doctors, nurses, and other health care professionals. They check the health of the participant, give specific instructions for participation, and monitor the participant from the beginning until the end of trial.
Some clinical trials involve more tests and doctor visits than the patient would normally have for an illness or condition. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
5) Can a participant leave a clinical trial after it has begun?
Once in the trial, the volunteer has the right to withdraw from a study at any time, for any reason. Participants should only consent to trials they have the intention of completing however, there are times when once in the trial, a person may not be able or want to continue.
If a participant wants to withdraw, he should tell the research team so that the team can make sure the participant stops the study treatment in a safe manner, and to ensure there is appropriate medical follow-up.