FAQs about clinical trials in cats and dogs
What is a clinical trial?
Clinical trials are research studies that allow doctors and scientists to find better ways to prevent, diagnose or treat a
particular disease such as cancer. Each trial is designed to answer specific scientific questions, figure out if the new
therapy is safe, what the side effects are, and if it is better than existing treatments in treating cancer. Every clinical trial
has a protocol, which describes what will be done in the study, how it will be conducted, and why each part of the study is
necessary.

Why should I enroll my pet in a clinical trial?
If your pet was diagnosed with cancer for which there is no effective treatment or your pet did not respond well to a
traditional treatment, enrolling in a clinical trial may provide you with an option to try new therapies. The treatment is
often available at decreased or no cost to you and even if your pet did not respond to the experimental therapy, its
participation will help pave the way for the development of better and more successful treatment methods in the future. It
is important to remember that you can remove your pet from the trial at any point and are not obligated to keep your pet
on the experimental therapy. There is no penalty and you are the ultimate decision maker whether you want to keep your
pet in the trial or not.

Where do I find clinical trials for cats and dogs with cancer?
For currently ongoing trials in dogs with cancer, please visit the "Dog Clinical Trials" section.
For currently ongoing trials in cats with cancer, please visit the "
Cat Clinical Trials" section.

Who is eligible to participate in a clinical trial?
Each study has its own guidelines on who can participate, called eligibility (or inclusion) criteria and who cannot
participate, called exclusion criteria. Examples of eligibility criteria for a clinical trial might be a particular type and stage
of cancer, age, gender, or previous treatments. Examples of exclusion criteria for a clinical trial might be other medical
conditions (eg heart disease), previous treatments, or results of a blood test (eg certain levels of liver enzymes).To find
out if your pet is eligible for a particular study, talk to the veterinarian in charge of the study and read the informed
consent. It is important to know that the inclusion and exclusion criteria are designed to protect the safety of the
participants and your pet should NOT be enrolled if the exclusion criteria clearly disqualify its participation.

What questions should I ask prior to enrolling?
The clinical trial
  •        What is the purpose of the study?
  •        Why do researchers think the proposed 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 my responsibilities be if I participate?
  •        Do you and/or your family members have the time, resources and willingness to commit to the care of your
               pet during and after the clinical trial?

Risks and benefits
  •        What are the possible short-term and long-term benefits?
  •        What are the short-term and long-term risks, such as side effects?
  •        What other options does my pet have?
  •        How do the possible risks and benefits of this trial compare with those other options?

Participation  and Care
  •        What kinds of therapies, procedures and /or tests will my pet have during the trial?
  •        Will they be painful and/or uncomfortable, and if so, for how long?
  •        How do the tests in the study compare with those outside of the trial?
  •        Will my pet be able to take its regular medications while in the clinical trial?
  •        Where will my pet have its medical care?
  •        Who will be in charge of the care?
  •        Can I talk to other people in the study?

Cost
  •        Will I have to pay for any part of the trial such as tests or the study drug?
  •        If so, what will the charges likely be?
  •        What is my pet health insurance likely to cover?

What are the potential risks and benefits of clinical trials?
Potential benefits of a clinical trial include:
  •        Health care provided by leading veterinarians in the field of cancer research
  •        Access to new therapies before they are widely available.
  •        Close monitoring of your pet's health
  •        If the approach being studied is found to be helpful, your pet may be among the first to benefit.
  •        An opportunity to make a valuable contribution to veterinary cancer research.

The potential risks of a clinical trial include:
  •        New therapies may have  risks unknown to the doctors at the time your pet enrolled.
  •        New therapies may be ineffective, or less effective compared to current treatments
  •        Even if the new approach has benefits, it may not work for your pet.

What happens during a trial?
If you decide to participate in a clinical trial, you will work with a research team who will provide your pet's care, monitor
its health carefully, and give specific instructions about the study.
Participating in a trial may mean that your pet might have more tests and doctor visits than it would if it weren't in the
study and the team members may continue to stay in contact with you about the health of your pet after the trial ends.
To make the trial results as reliable as possible, it is important for participants to follow the research team's instructions.
That means having all doctor visits and tests, taking medicines on time, and completing logs or answering
questionnaires. However, you may choose to withdraw from the trial at any point and are not obligated to finish the trial
should you decide that it is not right for your pet.

What are the different types of cancer clinical trials?
There are 4 different cancer clinical trials - prevention, screening, treatment and quality of life.

Treatment clinical trials
Treatment clinical trials test new therapies. These can include a new cancer drug, new surgical procedure, new radiation
therapy protocol, new combinations of treatments, novel treatment methods such as gene therapy, etc.

Prevention clinical trials
Prevention clinical trials test new approaches to prevent or at least slow down the development of cancer. These trials
can be conducted in pets who have never had cancer but may be at increased risk to develop cancer in the future, or to
prevent cancer from coming back in pets who were previously successfully treated. These approaches typically use new
or already existing drugs, vitamins, minerals, or other dietary supplements that doctors believe may lower the risk of a
certain type of cancer.

Screening clinical trials
Screening clinical trials test new ways to detect cancer at its earliest stage when patients have the best chance of cure.
The ultimate goal of successful cancer screening is to be able to conduct a simple test (eg blood test) that will be able to
detect beginning cancer before any symptoms occur.

Quality of Life Clinical Trials
Quality of Life clinical trials (also called Supportive Care clinical trials) test new ways of improving comfort and quality of
life for cancer patients.

What are the phases of clinical trials?
Most clinical trials are conducted in a series of steps called phases. This allows researchers to ask and answer specific
questions in a way that results in reliable information about the drug and protects the patients. Clinical trials are typically
classified into one of the following three phases:

Phase I trials: The primary goals of a Phase I trial are to evaluate safety of the new treatment, how an experimental drug
behaves in the pet's body, figure out the best way to give the new treatment (eg pill or injection), how often, and at what
dose. A phase I trial usually enrolls only a small number of patients and if the treatment appears to be well tolerated,
then it moves to Phase II. However, if the researchers find that the treatment causes significant side effects, then the trial
is discontinued. Sometimes, only one of many pets will experience side effects and in this case, the pet will be removed
from the trial while the others continue.

Phase II trials: A phase II trial continues to test the safety of the treatment and also begins to evaluate how well the new
treatment works in treating a particular type of cancer. If the new treatment continues to be well tolerated by the pets and
there are promising indications that it is successfully treating the cancer in question, then it moves to Phase III.

Phase III trials: A Phase III trial is designed to continue to monitor the safety of the treatment and to truly test how well the
new treatment works compared to an existing standard treatment. Phase III studies typically enroll a large number of pets
who are randomized by chance (not choice) into 2 groups - one group to be treated with the new experimental therapy
and the second group to be treated with what is considered standard medical care for the cancer in question. A
randomized, controlled trial is considered to be the most reliable and impartial method of determining what therapy works
best. The goal of randomization is to produce comparable groups in terms of general participant characteristics, such as
age or gender, and other key factors that affect the probable course the disease would take. In this way, the two groups
are as similar as possible at the start of the study so if one group has a better outcome than the other, the researchers
will be able to conclude with some confidence that the better outcome was due to the treatment rather than the age or
gender of the participants.
PET CANCER CENTER
Comprehensive guide to cancer diagnosis and treatment in cats and dogs
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© 2007 Pet Cancer Center. ALL RIGHTS RESERVED.
Last updated 4/10/13
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