Choosing to participate in a clinical trial
is an important personal decision. The following frequently asked questions
provide detailed information about clinical trials. In addition, it is often
helpful to talk to a physician, family members, or friends about deciding to
join a trial. After identifying some trial options, the next step is to contact
the study research staff and ask questions about specific trials.
A clinical trial (also clinical research) is
a research study in human volunteers to answer specific health questions.
Carefully conducted clinical trials are the fastest and safest way to find
treatments that work in people and ways to improve health. Interventional
trials determine whether experimental treatments or new ways of using known
therapies are safe and effective under controlled environments. Observational
trials address health issues in large groups of people or populations in
natural settings.
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.
Who can
participate in a clinical trial?
All clinical trials have guidelines about
who can participate. Using inclusion/exclusion criteria is an important
principle of medical research that helps to produce reliable results. The
factors that allow someone to participate in a clinical trial are called
"inclusion criteria" and those that disallow someone from
participating 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. Before joining a clinical
trial, a participant must qualify for the study. Some research studies seek
participants with illnesses or conditions to be studied in the clinical trial,
while others need healthy participants. 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 keep them safe. The
criteria help ensure that researchers will be able to answer the questions they
plan to study.
What
happens during a clinical trial?
The clinical trial process depends on the
kind of trial being conducted. The clinical trial team includes doctors and
nurses as well as social workers and other health care professionals. They
check the health of the participant at the beginning of the trial, give
specific instructions for participating in the trial, monitor the participant
carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and
doctor visits than the participant would normally have for an illness or
condition. For all types of trials, the participant works with a research team.
Clinical trial participation is most successful when the protocol is carefully
followed and there is frequent contact with the research staff.
Informed consent is the process of learning
the key facts about a clinical trial 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 trial 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 trial at any time.