About Clinical Research Studies
What are clinical research studies?
Clinical studies are a way to test investigational drugs to help develop future medicines
for people with diseases.
What are the phases of clinical research studies?
Clinical studies are divided into 4 phases:
Phase I: Researchers test an investigational drug in a small number of people by giving it to either healthy
volunteers or patients to evaluate its safety, determine a safe dosage range and identify side effects.
Phase II: The investigational drug is given to a larger number of people who have a particular disease or
condition to further evaluate its safety and often to assess its effectiveness.
Phase III: Several hundred to several thousand people with the appropriate disease or
condition participate in these studies. The investigational drug undergoes additional testing to further determine its safety
and effectiveness, monitor side effects, and compare it to commonly used treatments or placebo.
Phase IV: After a drug is available by prescription, additional information about a drug’s risks,
benefits and use may be gathered.
This clinical research study is a Phase III study. Doctors will evaluate the safety and effectiveness of elotuzumab as a potential treatment option for multiple myeloma.
Why are clinical research studies done?
Clinical research is necessary to learn whether the investigational study medications are effective and safe. The information gained from this
study could help future patients who need this type of medical care. All new treatments must pass all phases of their clinical studies before
they can be approved by the government regulatory agencies.
Why participate in a clinical research study?
A clinical research study participant works with a research team that includes doctors, nurses and other healthcare professionals.
The participant’s and study team’s commitment is important to help meet the objectives of the research study.
By participating in a clinical research study you may help others in the future by contributing to medical research. There is no
guarantee that you will benefit from participating in this study
What is informed consent?
Informed consent is the process of learning the key facts about a clinical study before deciding whether or not to participate.
It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or
not to participate, the doctors and nurses involved in the study explain the details of the study.
If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed
consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and
potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document.
Informed consent is not a contract, and the participant may withdraw from the study at any time.
What should I consider before participating in a clinical research study?
People should know as much as possible about the clinical study and feel comfortable asking the members of the health care team questions
about it, the care expected while in a study, and the cost of the study. The following questions might be helpful for the participant to
discuss with the health care team. Some of the answers to these questions are found in the informed consent document.
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental drug being tested may be effective? Has it been tested before?
- What kinds of tests and experimental drugs are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this study affect my daily life?
- How long will the study last?
- Will hospitalization be required?
- Who will pay for the experimental drug?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- How will I know that the experimental drug is working?
- Will results of the studies be provided to me?
- Who will be in charge of my care?
Click here to visit the study sponsor's Patient and Caregiver Clinical Study website, Bristol-Myers Squibb Study Connect