What are clinical trials?
Clinical trials are research studies that involve volunteers that follow
a pre-define protocol. They are studies that test new treatment and prevention
methods to find out if they are safe, effective, and better than the current
standard of care (the best known treatment).
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own
health care, gain access to new research treatments before they are widely
available, and help others by contributing to medical research.
What are the phases of a clinical trial?
Clinical trials are conducted in four phases, each with a different purpose
that help scientists answer different questions:
Phase 1: Evaluate safety, dosing and side effects of the treatment.
Phase 2: Test the effectiveness of the treatment and help further the safety profile.
Phase 3: Randomized trials in a large group of people and usually compare
the research treatment with the current standard treatment.
Phase 4: Take place after the treatment has been approved; the results
are used to further evaluate long-term safety and effectiveness of the
What is Informed Consent?
Informed consent is the ongoing process of learning the key facts about
a clinical trial while deciding whether or not to participate. The research
team provides an informed consent document including details about the
study such as its purpose, duration, required procedures, key contacts,
risks and potential benefits. The participant then decides whether or
not to participate. Informed consent is not a contract, and the participant
may withdraw from the trial at any time.
How is patient safety monitored?
Before a clinical trial begins, it must be approved by several regulatory
agencies (i.e. FDA) and an Institutional Review Board (IRB) which ensures
the protection of human participants. During the study, a data safety
monitoring board (DSMB) protects patient safety by regularly reviewing
the research data and making recommendations to stop, change or continue
the study. Patient safety is the highest priority in clinical trials.
All clinical trials have specific participation requirements which ensure
patient safety and also that the researchers get the information needed
to answer the study's questions.
What should people consider before participating in a trial?
People should know as much as possible and feel comfortable asking members
of their health care team questions about the trial and the care expected
while in the trial. The following questions might be helpful for the participant
to discuss with their health care team.
- What clinical trials are available to me and where can I learn more?
- What is the purpose of this clinical trial?
- What are the possible risks and benefits of participating in this clinical
trial? How do they compare to my current treatment?
- What other treatment options are available to me and what kinds of tests
and experimental treatments are involved?
- Where will the clinical trial take place? Will I need to stay in the hospital?
- Who will be in charge of my care?
- Will you continue to be a part of my care during the clinical trial?
- How might this trial affect my daily life and how long will the trial last?
- What type of long-term follow up care is part of this study?
- How will I know that the experimental treatment is working? Will results
of the trials be provided to me?
- What are my responsibilities during the clinical trial?
- Are there costs associated with my participation in this clinical trial?
- How will my participation in the clinical trial affect my privacy?
Is a clinical trial right for me?
Talk with your doctor to learn about current clinical trials and whether
they may be appropriate for you. As with any treatment, you need to weigh
the benefits of participating in a clinical trial against the potential
risks. Talking with people who have participated in a clinical trial might