Calendar of Events
Low Iodine Cookbook
Patient Packet - Free
Thyroid Cancer Facts
Thyroid Cancer Types/ Stages
Thyroid Cancer Basics Booklet
Papillary/Follicular Thyroid Cancer
Radiation: RAI EBR
Low Iodine Diet
Low Iodine Cookbook
After Receiving RAI
Medullary Thyroid Cancer
Anaplastic Thyroid Cancer
Pediatric Thyroid Cancer
HOW TO HELP
Become a Member
Donate to ThyCa
Give a Tribute Card
Intro for Physicians
files, you need Adobe Acrobat Reader.
Trials: Thoughts from a Patient and Caregiver
By Clayton and Rose Twigg
survivor of anaplastic thyroid cancer, and Rose have also contributed
to the Anaplastic Thyroid Cancer web
There are several
types of clinical trials:
Prevention trials test new approaches that doctors believe may
reduce the chance of developing cancer. Most involve healthy participants
without cancer. Others involve participants who have had cancer
to find ways to prevent second cancers.
trials test methods to better detect cancer at earlier stages.
trials seek to discover new approaches to diagnosing cancer at
trials seek to find new treatments or techniques that may be better
than current treatments.
Care or Quality of Life trials investigate ways to improve the
comfort of people with cancer. They may also be designed to investigate
better ways to manage treatment side effects.
Studies focus on how genetic makeup can impact detection, or response
in a clinical trial is a very individual choice and because it is
your choice, you may choose to leave the study at any time for any
is much to be considered, you may want to discuss the decision with
family and friends. Also consider getting a second medical opinion
about where you are in your treatment, whether you should consider
participating in a clinical trial, and, this specific clinical trial.
main concern may be, how do risks, side effects and possible benefits
compare to current available treatment, no less important is how
participation may impact daily life:
How often must I see the doctor / receive treatment / come in
long will I be in the study if I stay until completion?
I be hospitalized to receive treatment?
pays for the treatment - does the study sponsor or insurance cover
some or all of the cost?
expenses are my / my insurance company’s responsibility, might
- What are the benefit and the risks?
Close monitoring by cancer experts
chance to receive a promising therapy before it is (Food &
Drug Administration) FDA approved
chance to ‘make a difference’
results may help others in the future
Unknown side effects
treatment may be no better than standard care or it may not be
I am in a randomized trial, I will not be able to choose to receive
the new treatment
Trials Phase I –Is the treatment safe? The first step in testing
a new investigational drug in humans.
Is generally not disease specific
for the best way to give treatment, the best dose and how often
a small study population (20-30), generally at research institutions
where patients are closely monitored
treatment safety and identifies side effects, looks for dose limiting
toxicity, the maximum tolerated dose (MTD) above which side effects
become difficult to manage
Phase II – Does
the treatment work? Focus is on learning whether new treatment has
an anti cancer effect and may or may not be disease specific.- May
involve FDA drugs or procedures in a new combination
As in a Phase I trial, participation is still limited, generally
50 to 100 participants
the dose has generally been established in the Phase I trial,
side effects continue to be closely monitored
to treat may be implied, often based upon Phase I trials; this
trial has specific endpoints– does it shrink a tumor, improve
blood test results, improve quality of life, etc.
Phase III –
Is the new treatment better? Generally a comparison of new treatment
with results of people receiving standard treatment. Studies move
to Phase III only after a treatment shows promise in Phases I and
Larger, generally multi-center study, often not restricted to
one in a Phase III study is left without any treatment when standard
treatment is available; the study may have multiple treatment
arms, comparing current ‘standard of care’ to a new therapy.
no standard treatment exists for a cancer, studies may compare
new treatment with a placebo.
Phase IV - Are
there better ways to use the treatment? Researchers may continue
to study a drug after it has been FDA approved. These trials are
generally designed to discover additional risks and benefits in
a much larger population, helping doctors understand long-term safety
& efficacy of a new drug.
is the process by which you agree to participate in a clinical trial
after having had the purpose, treatment and testing procedures,
risks, and benefits explained to you.
You may want
to have a family member or friend with you during the consent process.
Much information will be shared. Two pairs of ears are better than
will be conducted in the following manner. It should:
take place without undue influence or pressure from the study
allow subjects time to consider the research before signing the
conducted in a private place and manner,
conducted with words understandable to subjects & written
at an 8th grade reading level
subjects the opportunity to ask questions
the subject to take home an unsigned copy of the consent form
to be shared with family/friends prior to enrollment if he/she
a certified translator for those who are non English speaking
in the subject’s first language
you will be given a signed & dated copy of the consent form
for your records.
will vary depending upon several factors, including disease site
& disease stage, intervention proposed and individual Institutional
Review Boards (IRB).
consent form may be required if you are being asked to provide blood
or tissue samples for testing.
honestly express realistic expectations for participating in the
research study, avoiding inducement by raising false hope
information in simple, non-technical lay terms (but, ask any question
you may have)
a consent form
Section headers are usually written as questions. Information provided
below each header will likely be in paragraph form, will answer
these questions, and be similar to the following:
Purpose / Invitation should contain a statement that:
Description of Study should provide the following information:
is the study’s purpose- what will be done, timeline of screening
procedures, treatment cycles, testing, follow-up
will I receive treatment – doctor’s office, as an out-patient
or will I be hospitalized
will it be done – length of study participation for me
are my responsibilities as a participant
I be told if new information (good or bad) about the drug
is discovered during the study
Selection of Subjects will likely include:
whether there are restrictions as to who may or may not participate
in the study
have I been asked to join the study
many participants will there be
associated with study — are there any (known drug) benefits
associated with study — is there any (known drug) hazard
There Alternative Therapies:
alternatives to study participation may be noted in the consent
or the study doctor will discuss them with you during the
informed consent process
I decide not to participate or choose to leave the study,
will I lose benefits, medical treatment or legal rights to
which I am otherwise entitled
of Confidentiality, Health Information Portability & Accountability
may receive study results
my consent authorization expire
my name ever be made public
I be paid for participation or reimbursed for travel, parking,
compensation be made for injury/adverse reactions and who
will pay for this treatment
—will participation result in extra cost to me for tests, medications,
doctor visits, etc.
name & contact information of doctor and/ or study nurse
conducting the study
number for legal questions: Institutional Review Board (IRB)
telephone number to be used in the event of an out-of-hours
Section— contains places for the following persons who must sign
and date this section of the consent form
You will receive
a copy of the signed consent form to keep for your records.