Cancer Care | Clinical Trials - FAQ
For specific information regarding Clinical Cancer Research Trials at Lake
Huron Medical Center, contact Kathleen Fisher, RN, directly at 810-216-1185.
- What is a Clinical Trial?
- Why are there Clinical Trials?
- What are the Different Types of Clinical Trials?
- What are the phases of Clinical Trials?
- Where Do Ideas for Clinical Trials Come From?
- What is a Protocol?
- Who Sponsors Clinical Trials?
- Should I take part in a Clinical Trial?
- What are the potential risks and benefits of Clinical Trials?
- How are Participants Protected?
- What is Informed Consent?
- Could I receive a Placebo?
- What Happens During a Clinical Trial?
- What happens when a Clinical Trial is over?
What is a Clinical Trial?
Clinical trials are research studies in which people help doctors find
ways to improve health and cancer care. Each study tries to answer scientific
questions and to find better ways to prevent, diagnose, or treat cancer.
Why are there Clinical Trials?
A clinical trial is one of the final stages of a long and careful cancer
research process. Studies are done with cancer patients to find out whether
promising approaches to cancer prevention, diagnosis, and treatment are
safe and effective.
What are the Different Types of Clinical Trials?
- Treatment trials test new treatments (like a new cancer drug, new approaches
to surgery or radiation therapy, new combinations of treatment, or new
methods such as gene therapy.
- Prevention trials test new approaches, such as medicines, vitamins, minerals,
or other supplements that doctors believe may lower the risk of a certain
type of cancer. These trials look for the best way to prevent cancer in
people who have never had cancer, or to prevent cancer from coming back,
or a new cancer occurring in people who have already had cancer.
- Screening trials test the best way to find cancer, especially in its early stages.
- Quality of Life trials (also called Supportive Care trials) explore ways
to improve comfort and quality of life for cancer patients.
What are the phases of Clinical Trials?
Most clinical research that involves the testing of a new drug progresses
in an orderly series of steps, called phases. This allows researchers
to ask and answer questions in a way that results in reliable information
about the drug and protects the patients. Clinical trials are usually
classified into one of three phases:
Phase I Trials: These first studies in people evaluate how a new drug should be given
(by mouth, injected into the blood, or injected into the muscle), how
often, and what dosage is safe. A Phase I trial usually enrolls only a
small number of patients, sometimes as few as a dozen.
Phase II Trials: A Phase II trial continues to test the safety of the drug, and begins
to evaluate how well the new drug works. Phase II trials usually focus
on a particular type of cancer.
Phase III Trials: These studies 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).
Phase III trials often enroll large numbers of people and may be conducted
at many doctors' offices, clinics, and cancer centers.
Where Do Ideas for Clinical Trials Come From?
The ideas for clinical trials often originate in the laboratory. Researchers
develop a clinical trial protocol (a plan for a trial) after laboratory
studies indicate the promise of a new drug or procedure. The first trials
of a particular drug or procedure are focused on safety (Phase I), and
later trials focus on whether the drug or procedure is effective (Phase
II or Phase III).
What is a Protocol?
Every trial has a person in charge, usually a doctor, who is called the
protocol chair or principal investigator. Phase I and Phase II studies
generally refer to the person in charge as the principal investigator.
Phase III studies generally have a protocol chair, under whose direction
multiple principal investigators carry out the protocol in participating
sites. The protocol chair or principal investigator prepares a plan for
the study, called a protocol. The protocol explains what the study will
do, how it will be carried out, and why each part of the study is necessary.
For example, the protocol includes:
- The reason for doing the study
- How many people will be in the study
- Who is eligible to participate in the study
- What study drugs the participants will take, if any
- What medical tests they will have, if any, and how often
- What information will be gathered
Every doctor or research center that takes part in the trial uses the same
protocol. This ensures that patients are treated identically, and that
information from all the participating centers (if there are more than
one) can be combined and compared.
Who Sponsors Clinical Trials?
Clinical trials are sponsored by organizations or individuals who are seeking
better treatments for cancer or better ways to prevent or detect cancer.
Individual physicians at cancer centers and other medical institutions
can sponsor clinical trials themselves.
The National Cancer Institute (NCI) sponsors a large number of clinical
trials. The NCI has a number of programs designed to make clinical trials
widely available in the United States. Thousands of investigators at over
a thousand sites participate in various aspects of NCI's clinical
trials program. These include:
Cancer Center Program: About 60 research-oriented institutions have been designated as an NCI
Comprehensive or Clinical Cancer Center for their scientific excellence.
The centers are key partners in the NCI's efforts to bring the benefits
of clinical research directly to you. Located throughout the country,
they play an important role in cancer research, delivery of the highest
quality cancer care, and outreach and education for the public and professionals.
Cooperative Clinical Trials Program: This program brings together groups of researchers, cancer centers, and
community physicians into a national NCI-supported network. The network
consists of a number of Cooperative Groups that seek to define the key
unanswered questions in cancer and then conduct high-quality clinical
trials at many sites around the country to answer these questions. The
Cooperative Groups enroll about 20,000 new patients in treatment trials
each year. Important Phase III trials run by the Cooperative Groups help
establish the state-of-the-art for cancer therapy. Additionally, the Groups
perform large cancer prevention trials.
The National Cancer Institute Community Oncology Research Program: This program makes clinical trials available in a large number of local
communities in the United States by linking community physicians with
researchers in cancer centers. Local hospitals throughout the country
affiliate with a cancer center or a Community Oncology Research Program.
This enables doctors to offer people participation in clinical trials
more easily, without having to travel long distances or leave their usual
caregivers. Several of these programs focus on encouraging minority populations
to participate in trials. The Nevada Cancer Research Foundation (NCRF)
NCI Community Oncology Research Program has been funded by the National
Cancer Institute since 1994. The LHMCC has been a part of a community
clinical oncology program since 2007.
Should I take part in a Clinical Trial?
Only you can make the decision about whether or not to participate in a
clinical trial. Before making your decision, you should:
- Learn as much as possible about your disease and the trials that are available to you.
- Talk to your doctor/or nurse, family members and friends to help you determine
what is right for you.
What are the potential risks and benefits of Clinical Trials?
Potential benefits include:
- Health care provided by leading physicians in the field of cancer research.
- Access to new drugs and interventions before they are widely available.
- Close monitoring of your health care and any side effects.
- A more active role in your own health care.
- If the approach being studied is found to be helpful, you may be among
the first to benefit.
- An opportunity to make a valuable contribution to cancer research.
The potential risks include:
- New drugs and procedures may have side effects or risks unknown to the doctors.
- New drugs and procedures may be ineffective, or less effective, than current
- Even if a new approach has benefits, it may not work for you.
How are Participants Protected?
The government has a system designed to protect human research subjects.
Before a government-funded clinical trial can begin, the trial plan (also
called a protocol) must be approved. During the trial, review committees
make sure that the plan is being followed and participants are being protected.
Regulations require the researchers performing studies to thoroughly inform
patients about a study's treatment, tests, their possible benefits,
and potential risks before a patient decides whether or not to participate
in any study. This process is called informed consent.
The NCRF Central Oncology Institutional Review Board (IRB) approves all
local research studies. The IRB includes both scientific and non-scientific
members and is dedicated to the integrity of the research goals and objectives
as well as protecting the rights of all participants.
Assuring that the process to enroll study participants includes informed
consent on behalf of patients is a major responsibility of the IRB. Anyone
participating in a research protocol has a right to understand the pros
and cons of participation. The IRB reviews the informed consent document
for each patient enrolled in a NCRF IRB-approved study.
What is Informed Consent?
Informed consent is a process in which you learn the key facts about a
clinical trial before you decide whether or not to participate. In addition
to talking about these facts with the research doctor or nurse, the facts
will be included in a written consent form that you can take home to read
and discuss. The consent form will include details about:
- The study approach
- The intervention given in the trial
- The possible risks and benefits
- The tests you may have
Don't hesitate to ask questions until you have all the information
you need. While informed consent begins before you agree to participate
in a trail, you should feel free to ask the health care team any questions
you have at any point. Informed consent continues as long as you are in
the study. You can change your mind and leave the study whenever you want
- before the study starts or at any time during the study or follow-up period.
Could I receive a Placebo?
In treatment trials involving people who have cancer, placebos ("dummy"
pills that contain no active ingredient) are rarely used.
Many treatment trials are designed to compare a new treatment with a standard
treatment, which is the best treatment currently known for a cancer based
on results of past research. In these studies, patients are randomly assigned
to one group or another.
When no standard treatment exists for a cancer, a study may compare a new
treatment with a placebo. However, you will be told about this possibility
during informed consent, before you decide whether or not to take part
in the study.
What Happens During a Clinical Trial?
If you decide to participate in a clinical trial, you will work with a
research team. Team members may include doctors, nurses, social workers,
dietitians and other health care professionals. They will provide your
care, monitor your health carefully, and give you specific instructions
about the study.
Participating in a trial may mean that you might have more tests and doctor
visits than you would if you weren't in the study. Team members also
may continue to stay in contact with you 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 attending all
doctor visits and having tests, taking medicines on time, and completing
logs or answering questionnaires.
What happens when a Clinical Trial is over?
After a Phase I or Phase II trial is completed, the researchers look carefully
at the data collected during the trial to decide whether to:
- Move to the next trial with the treatment, or
- Stop testing the treatment because it is not safe or effective
When a Phase III trial comes to an end, the researchers must look at the
data and decide if the results have medical importance. When the analysis
of a Phase I, Phase II, or Phase III trial is complete, the researchers
will inform the medical community and the public of the study results.
In most cases, the results of trials are published in scientific or medical
journals. To find out if the results of a study you participated in was
published, ask the doctor or nurse in charge of your treatment.
Most medical and scientific journals have in place a process of peer review,
in which experts critique the report before it is published, to make sure
that the analysis and conclusions are sound. Particularly important results
are likely to be featured by the print or electronic media, and widely
discussed at scientific meetings and by patient advocacy groups. Once
an intervention is proven safe and effective in a clinical trial, it may
become the new standard of practice. In this way the development of better
interventions for prevention, for treatment, or for detection and diagnosis
is an ongoing, continuous process that builds progressively on itself
to improve the quality of cancer care and prevention available to all.