By Hilary Wright
Phase III trials: test a new drug, a new
combination of drugs, or a new surgical
procedure in comparison to the current standard.
A participant will usually be assigned to the
standard group or the new group at random
(called randomization). This phase often enrolls
large numbers of people and may be conducted at
many doctors' offices, clinics, and cancer
centers nationwide.
In order to assure the safety of those who are
about to undergo a clinical trial, the government
has designed a system that requires a trial plan,
known as the protocol, to first be approved. After
approval, a review committee is then assigned to the
clinical trial in order to continually monitor the
study, making sure that the original protocol is
being followed and that the participants are being
protected. Government regulations also require a
patient to go through a process called “informed
consent” prior to deciding whether or not they want
to participate in a specific clinical trial.
Informed consent is when researchers performing the
study thoroughly inform patients about the
treatments and tests, and what the possible benefits
and risks will be. Along with talking with the
research doctor or nurse, a written consent form
will also be given to take home to read and discuss.
The consent form will include details about:
- the approach of the study
- the intervention given in the trial
- the possible risks and benefits
- the tests you may have to undergo
Remember to continually ask questions until
satisfied that all the information needed is
understood. Although informed consent begins prior
to your loved one agreeing to participate in the
clinical trial, always feel free to ask the
healthcare team any questions at any point. Informed
consent continues as long as your loved one is
involved with the study. A participant has the right
to change their mind and leave the clinical trial
whenever they want, whether it’s before the study
starts, during the actual study or during the
follow-up period.
Clinical trials are conducted in a number of places,
including large cancer centers,
university hospitals, at local medical centers, or
at a doctor's office. Depending upon the type of
clinical trial and based on the intervention it's
designed to study, the trial may include
participants at one or two highly specialized
centers, or it may involve hundreds of locations at
the same time. Clinical trials are conducted under
the guidance of a healthcare team which includes
your loved one’s doctor, along with other health
professionals. The information from all the
participants is then used by experts who evaluate
the intervention that the trial is testing.
Deciding upon whether or not your loved one
becomes a participant in a cancer clinical trial is
completely up to them. However, there are some very
important questions you and your loved one both
should get answered:- What is the purpose of the
study?
- Why do researchers think the approach may be
effective?
- Who will sponsor the study?
- Who has reviewed and approved the study?
- How are study results and safety of participants
being checked?
- How long will the study last?
- What will the responsibilities be if I
participate?
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