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FAQ
Frequently Asked Questions about
Clinical Trials
Informed Consent
Documents regarding informed consent
Insurance
General information about
insurance
Myths and Facts
Myths
and Facts about Clinical Trials
Dr. Alan Lyss, Heartland CCOP Principal
Investigator and cancer Research ProgramDirector at
Missouri Baptist Medical
Center, talks about receiving the NCI
CCOP designation in 2005
Frequently Asked Questions about Clinical Trials
What are clinical
trials and why are they important?
What are the types of clinical
trials?
Who sponsors clinical trials?
How are participants
protected?
What are eligibility criteria and why are they important?
What is informed consent?
Where do clinical trials take place?
How
are clinical trials conducted?
What are some of the benefits of taking
part in a clinical trial?
What are some of the possible risks associated
with taking part in a clinical trial?
Who pays for the patient care
costs associated with a clinical trial?
What are some questions people
might ask their health care provider before entering a clinical trial?
What happens when a clinical trial is over?
Where can people find more
information about clinical trials?
-
What are clinical trials, and why are they important?
Clinical trials are research studies that test how well new
medical approaches work in people. Each study answers scientific questions
and tries to find better ways to prevent, screen for, diagnose, or treat a
disease. People who take part in cancer clinical trials have an opportunity
to contribute to knowledge of, and progress against, cancer. They also
receive up-to-date care from experts.
- What
are the types of clinical trials?
There are several types of
clinical trials:
- Prevention trials test
new approaches, such as medications, vitamins, or other supplements, that
doctors believe may lower the risk of developing a certain type of cancer.
Most prevention trials are conducted with healthy people who have not had
cancer. Some trials are conducted with people who have had cancer and want
to prevent recurrence (return of cancer), or reduce the chance of developing
a new type of cancer.
- Screening trials study
ways to detect cancer earlier. They are often conducted to determine whether
finding cancer before it causes symptoms decreases the chance of dying from
the disease. These trials involve people who do not have any symptoms of
cancer.
- Diagnostic Trials
study tests or procedures that could be used to identify cancer more
accurately. Diagnostic trials usually include
people who have signs or symptoms of cancer.
- Treatment trials are
conducted with people who have cancer. They are designed to answer specific
questions about, and evaluate the effectiveness of, a new treatment or a new
way of using a standard treatment. These trials test many types of
treatments, such as new drugs, vaccines, new approaches to surgery or
radiation therapy, or new combinations of treatments.
- Quality-of-Life (also
called supportive care) trials explore ways to improve the comfort and
quality of life of cancer patients and cancer survivors. These trials may
study ways to help people who are experiencing nausea, vomiting, sleep
disorders, depression, or other effects from cancer or its treatment.
- Genetics studies are
sometimes part of another cancer clinical trial. The genetics component of
the trial may focus on how genetic makeup can affect detection, diagnosis,
or response to cancer treatment.
Population- and family-based
genetic research studies differ from traditional cancer clinical trials. In
these studies, researchers look at tissue or blood samples, generally from
families or large groups of people, to find genetic changes that are
associated with cancer. People who participate in genetics studies may or
may not have cancer, depending on the study. The goal of these studies is to
help understand the role of genes in the development of cancer.
- Who sponsors clinical
trials?
Government agencies, such as the National Cancer Institute (NCI) and other
parts of the National Institutes of Health (NIH), the Department of Defense,
and the Department of Veterans Affairs, sponsor and conduct clinical trials.
In addition, organizations or individuals, such as physicians, medical
institutions, foundations, volunteer groups, and pharmaceutical companies,
also sponsor clinical trials.
NCI sponsors a large number of clinical
trials and has a number of programs designed to make clinical trials widely
available in the United States. These programs include the following:
- The Cancer Centers
Program provides support to research-oriented institutions, including those
that have been designated as NCI Comprehensive or Clinical Cancer Centers
for their scientific excellence. More information is available in the NCI
fact sheet The National Cancer Institute Cancer Centers Program, which is
available at
http://www.cancer.gov/cancertopics/factsheet/NCI/cancer-centers on the
Internet.
- The Specialized
Programs of Research Excellence (SPOREs) bring together scientists and
researchers to design and implement research programs that can improve
prevention, detection, diagnosis, and treatment of specific types of cancer.
More information about SPOREs is available at
http://spores.nci.nih.gov/index.html on the Internet.
- The Clinical Trials
Cooperative Group Program brings researchers, cancer centers, and doctors
together into cooperative groups. These groups work with the NCI to identify
important questions in cancer research, and design and conduct multisite
clinical trials to answer these questions. Cooperative groups are located
throughout the United States and in Canada and Europe. For more information,
refer to the fact sheet NCI’s Clinical Trials Cooperative Group Program at
http://www.cancer.gov/cancertopics/factsheet/NCI/clinical-trials-cooperative-group
on the Internet.
- The Cancer Trials
Support Unit (CTSU) makes NCI-sponsored phase III treatment trials available
to doctors and patients in the United States and Canada . Doctors who are
not affiliated with an NCI-sponsored Clinical Trials Cooperative Group (see
above) must complete an application process, which includes credential
verification and site preparedness assessment, to become members of the
CTSU’s National Network of Investigators. CTSU members can enroll patients
in clinical trials through the program’s Web site, which is located at
http://www.ctsu.org/ on the Internet. General
information about the CTSU is also available on the program’s Web site, or
by calling 1–888–823–5923.
- The Community Clinical
Oncology Program (CCOP) makes clinical trials available in a large number of
communities across the United States. Local hospitals throughout the country
affiliate with a cancer center or a cooperative group. This affiliation
allows doctors to offer people participation in clinical trials more easily,
so they do not have to travel long distances or leave their usual
caregivers. The Minority-Based Community Clinical Oncology Program focuses
on encouraging minority populations to participate in clinical trials. More
information about the CCOP can be found in the NCI fact sheet Community
Clinical Oncology Program: Questions and Answers, which is available at
http://www.cancer.gov/cancertopics/factsheet/NCI/CCOP
on the Internet.
- The National
Institutes of Health Clinical Center, a research hospital located in
Bethesda, Maryland, is part of the NIH. Trials at the Clinical Center are
conducted by the components of the NIH, including the NCI. The NCI fact
sheet Cancer Clinical Trials at the National Institutes of Health Clinical
Center: Questions and Answers has more information about the Clinical
Center. This fact sheet is available at
http://www.cancer.gov/cancertopics/factsheet/NCI/clinical-center
on the Internet.
-
How are participants
protected?
Research with people is conducted according to strict
scientific and ethical principles. Every clinical trial has a protocol, or
action plan, which acts like a “recipe” for conducting the trial. The plan
describes what will be done in the study, how it will be conducted, and why
each part of the study is necessary. The same protocol is used by every
doctor or research center taking part in the trial.
All clinical
trials that are federally funded or that evaluate a new drug or medical
device subject to Food and Drug Administration regulation must be reviewed
and approved by an Institutional Review Board (IRB). Many institutions
require that all clinical trials, regardless of funding, be reviewed and
approved by a local IRB. The Board, which includes doctors, researchers,
community leaders, and other members of the community, reviews the protocol
to make sure the study is conducted fairly and participants are not likely
to be harmed. The IRB also decides how often to review the trial once it has
begun. Based on this information, the IRB decides whether the clinical trial
should continue as initially planned and, if not, what changes should be
made. An IRB can stop a clinical trial if the researcher is not following
the protocol or if the trial appears to be causing unexpected harm to the
participants. An IRB can also stop a clinical trial if there is clear
evidence that the new intervention is effective, in order to make it widely
available.
NIH-supported clinical trials require data and safety
monitoring. Some clinical trials, especially phase III clinical trials, use
a Data and Safety Monitoring Board (DSMB). A DSMB is an independent
committee made up of statisticians, physicians, and patient advocates. The
DSMB ensures that the risks of participation are as small as possible, makes
sure the data are complete, and stops a trial if safety concerns arise or
when the trial’s objectives have been met.
-
What are eligibility criteria, and why are they important?
Each
study’s protocol has guidelines for who can or cannot participate in the
study. These guidelines, called eligibility criteria, describe
characteristics that must be shared by all participants. The criteria differ
from study to study. They may include age, gender, medical history, and
current health status. Eligibility criteria for treatment studies often
require that patients have a particular type and stage of cancer.
Enrolling participants with similar characteristics helps to ensure that the
results of the trial will be due to what is under study and not other
factors. In this way, eligibility criteria help researchers achieve accurate
and meaningful results. These criteria also minimize the risk of a person’s
condition becoming worse by participating in the study.
-
What is informed consent?
Informed consent is a process by which people learn the important facts
about a clinical trial to help them decide whether to participate. This
information includes details about what is involved, such as the purpose of
the study, the tests and other procedures used in the study, and the
possible risks and benefits. In addition to talking with the doctor or
nurse, people receive a written consent form explaining the study. People
who agree to take part in the study are asked to sign the informed consent
form. However, signing the form does not mean people must stay in the study.
People can leave the study at any time—either before the study starts or at
any time during the study or the follow-up period.
The informed
consent process continues throughout the study. If new benefits, risks, or
side effects are discovered during the study, the researchers must inform
the participants. They may be asked to sign new consent forms if they want
to stay in the study.
-
Where do clinical
trials take place?
Clinical trials take place in doctors’
offices, cancer centers, other medical centers, community hospitals and
clinics, and veterans’ and military hospitals in cities and towns across the
United States and in other countries. Clinical trials may include
participants at one or two highly specialized centers, or they may involve
hundreds of locations at the same time.
-
How are clinical
trials conducted?
Clinical trials are usually conducted in a
series of steps, called phases. Treatment clinical trials listed in PDQ
(Physician Data Query), the NCI’s comprehensive cancer information database,
are always assigned a phase. However, screening, prevention, diagnostic, and
quality-of-life studies do not always have a phase. Genetics clinical trials
generally do not have a phase.
- Phase I trials are the
first step in testing a new approach in people. In these studies,
researchers evaluate what dose is safe, how a new agent should be given (by
mouth, injected into a vein, or injected into the muscle), and how often.
Researchers watch closely for any harmful side effects. Phase I trials
usually enroll a small number of patients and take place at only a few
locations. The dose of the new therapy or technique is increased a little at
a time. The highest dose with an acceptable level of side effects is
determined to be appropriate for further testing.
- Phase II rials study
the safety and effectiveness of an agent or intervention, and evaluate how
it affects the human body. Phase II studies usually focus on a particular
type of cancer, and include fewer than 100 patients.
- Phase III trials
compare a new agent or intervention (or new use of a standard one) with the
current standard therapy. Participants are randomly assigned to the standard
group or the new group, usually by computer. This method, called
randomization, helps to avoid bias and ensures that human choices or other
factors do not affect the study’s results. In most cases, studies move into
phase III testing only after they have shown promise in phases I and II.
Phase III trials often include large numbers of people across the country.
- Phase IV trials are
conducted to further evaluate the long-term safety and effectiveness of a
treatment. They usually take place after the treatment has been approved for
standard use. Several hundred to several thousand people may take part in a
phase IV study. These studies are less common than phase I, II, or III
trials.
People who participate in a clinical trial work with a research team. Team
members may include doctors, nurses, social workers, dietitians, and other
health professionals. The health care team provides care, monitors participants’
health, and offers specific instructions about the study. So that the trial
results are as reliable as possible, it is important for participants to follow
the research team’s instructions. The instructions may include keeping logs or
answering questionnaires. The research team may continue to contact participants
after the trial ends.
-
What are some of the benefits of taking part in a clinical trial?
The benefits of participating in a clinical trial include the following:
- Participants have
access to promising new approaches that are often not available outside the
clinical trial setting.
- The approach being
studied may be more effective than the standard approach.
- Participants receive
regular and careful medical attention from a research team that includes
doctors and other health professionals.
- Participants may be
the first to benefit from the new method under study.
- Results from the study
may help others in the future.
-
What are some of the possible risks associated with taking part in a
clinical trial?
The possible risks of participating in a clinical
trial include the following:
- New drugs or
procedures under study are not always better than the standard care to which
they are being compared.
- New treatments may
have side effects or risks that doctors do not expect or that are worse than
those resulting from standard care.
- Participants in
randomized trials will not be able to choose the approach they receive.
- Health insurance and
managed care providers may not cover all patient care costs in a study.
- Participants may be
required to make more visits to the doctor than they would if they were not
in the clinical trial.
-
Who pays for the patient care costs associated with a clinical trial?
Health insurance and managed care providers often do not cover the
patient care costs associated with a clinical trial. What they cover varies
by health plan and by study. Some health plans do not cover clinical trials
if they consider the approach being studied "experimental" or
"investigational.” However, if enough data show that the approach is safe
and effective, a health plan may consider the approach “established” and
cover some or all of the costs. Participants may have difficulty obtaining
coverage for costs associated with prevention and screening clinical trials;
health plans are currently less likely to have review processes in place for
these studies. It may, therefore, be more difficult to get coverage for the
costs associated with them. In many cases, it helps to have someone from the
research team talk about coverage with representatives of the health plan.
Health plans may specify other criteria a trial must meet to be covered.
The trial might have to be sponsored by a specified organization, be judged
“medically necessary” by the health plan, not be significantly more
expensive than treatments the health plan considers standard, or focus on
types of cancer for which no standard treatments are available. In addition,
the facility and medical staff might have to meet the plan’s qualifications
for conducting certain procedures, such as bone marrow transplantations.
More information about insurance coverage can be found on the NCI’s Clinical
Trials and Insurance Coverage: A Resource Guide Web page at
http://www.cancer.gov/clinicaltrials/learning/insurance-coverage
on the Internet.
Many states have passed legislation or
developed policies requiring health plans to cover the costs of certain
clinical trials. For more information, visit the NCI’s Web site at
http://www.cancer.gov/clinicaltrials/developments/laws-about-clinical-trial-costs
on the Internet.
Federal programs that help pay the costs of
care in a clinical trial include those listed below:
- Medicare reimburses
patient care costs for its beneficiaries who participate in clinical trials
designed to diagnose or treat cancer. Information about Medicare coverage of
clinical trials is available at
http://www.medicare.gov/ on the Internet, or
by calling Medicare’s toll-free number for beneficiaries at 1–800–633–4227
(1–800–MEDICARE). The toll-free number for the hearing impaired is
1–877–486–2048. Also, the NCI fact sheet More Choices in Cancer Care:
Information for Beneficiaries on Medicare Coverage of Cancer Clinical Trials
is available at
http://www.cancer.gov/cancertopics/factsheet/support/medicare
on the Internet.
- Beneficiaries of
TRICARE, the Department of Defense’s health program, can be reimbursed for
the medical costs of participation in NCI-sponsored phase II and phase III
cancer prevention (including screening and early detection) and treatment
trials. Additional information is available in the NCI fact sheet TRICARE
Beneficiaries Can Enter Clinical Trials for Cancer Prevention and Treatment
Through a Department of Defense and National Cancer Institute Agreement.
This fact sheet can be found at
http://www.cancer.gov/cancertopics/factsheet/NCI/TRICARE
on the Internet.
- The Department of
Veterans Affairs (VA) allows eligible veterans to participate in
NCI-sponsored prevention, diagnosis, and treatment studies nationwide. All
phases and types of NCI-sponsored trials are included. The NCI fact sheet
The NCI/VA Agreement on Clinical Trials: Questions and Answers has more
information. It is available at
http://www.cancer.gov/cancertopics/factsheet/NCI/VA-clinical-trials
on the Internet.
-
What are some questions people might ask their health care provider before
entering a clinical trial?
It is important for people to ask
questions before deciding to enter a clinical trial. Questions people might
want to ask their doctor or nurse include the following:
The
Study
- What is the purpose of
the study?
- Why do the researchers
think the approach being tested may be effective? Has it been tested before?
- Who is sponsoring the
study?
- Who has reviewed and
approved the study?
- What are the medical
credentials and experience of the researchers and other study personnel?
- How are the study
results and safety of participants being monitored?
- How long will the
study last?
- How will the results
be shared?
Possible Risks and Benefits
- What are the possible short-term
benefits?
- What are the possible long-term
benefits?
- What are the short-term risks, such as
side effects? What are the possible long-term risks?
- What other treatment options are
available?
- How do the possible risks and benefits
of the trial compare with those of other options?
Participation and Care
- What kinds of treatment, medical
tests, or procedures will the participants have during the study? How
often will they receive the treatments, tests, or procedures?
- Will treatments, tests, or procedures
be painful? If so, how can the pain be controlled?
- How do the tests in the study compare
with what people might receive outside the study?
- Will participants be able to take
their regular medications while in the clinical trial?
- Where will the participants receive
their medical care? Will they be in a hospital? If so, for how long?
- Who will be in charge of the
participants’ care? Will they be able to see their own doctors?
- How long will participants need to
stay in the study? Will there be follow-up visits after the study?
Personal Issues
- How could being in the study affect
the participants’ daily lives?
- What support is available for
participants and their families?
- Can potential participants talk with
people already enrolled in the study?
Cost Issues
- Will participants have to pay for any
treatment, tests, or other charges? If so, what will the approximate charges
be?
- What is health insurance likely to
cover?
- Who can help answer questions from the
insurance company or health plan?
-
What happens
when a clinical trial is over?
After a clinical trial is
completed, the researchers look carefully at the data collected during the
trial before making decisions about the meaning of the findings and further
testing. After a phase I or II trial, the researchers decide whether to move
on to the next phase, or stop testing the agent or intervention because it
was not safe or effective. When a phase III trial is completed, the
researchers look at the data and decide whether the results have medical
importance.
The results of clinical trials are often published in
peer-reviewed, scientific journals. Peer review is a process by which
experts review the report before it is published to make sure the analysis
and conclusions are sound. If the results are particularly important, they
may be featured by the media and discussed at scientific meetings and by
patient advocacy groups before they are published. Once a new approach has
been proven safe and effective in a clinical trial, it may become standard
practice. (Standard practice is a currently accepted and widely used
approach.)
The National Library of Medicine’s Web site offers links
to resources for finding the results of clinical trials. It includes
information about published and unpublished results. This resource can be
found at
http://www.nlm.nih.gov/services/ctresults.html
on the Internet.
-
Where can people find more information about clinical trials?
In
addition to the resources described in Question 3, people interested in
taking part in a clinical trial should talk with their health care provider.
Information about cancer clinical trials is also available from the NCI's
Cancer Information Service (CIS). The CIS is the National Cancer Institute's
link to the public, interpreting and explaining research findings in a clear
and understandable manner, and providing personalized responses to specific
questions about cancer. Access the CIS by calling 1-800-4-CANCER
(1-800-422-6237), or by using the LiveHelp instant-messaging service at
https://cissecure.nci.nih.gov/livehelp/welcome.asp.
Information specialists at the CIS use PDQ to identify and
provide detailed information about specific ongoing clinical trials. PDQ
includes all NCI-funded clinical trials and some studies conducted by
independent investigators at hospitals and medical centers in the United
States and Europe.
People also have the option of searching for
clinical trials on their own. The clinical trials page of the NCI's Web
site, located at
http://www.cancer.gov/clinicaltrials/ on the
Internet, provides information about clinical trials and links to PDQ.
Another resource is the NIH's ClinicalTrials.gov Web site.
ClinicalTrials.gov lists clinical trials sponsored by the NIH, other Federal
agencies, and the pharmaceutical industry for a wide range of diseases,
including cancer and other conditions. This site can be found at
http://clinicaltrials.gov/ on the Internet.
Related Resources
Informed
Consent
What is “Informed Consent”? See a sample
document and know what to look for…take a look at the informed consent tips and
checklist.
Informed Consent: An ongoing Process
Why It's Important
Process
Myths
and Facts
Informed Consent Document
Document Sections
Informed Consent: An Ongoing Process
Anyone who has undergone any kind of
medical test or procedure has signed an
informed consent form, often without
really reading or understanding it. But
for cancer patients who are considering
participation in a clinical trial, the
informed consent form is a critical part
of the decision process because it
outlines the potential risks and
benefits and provides an opportunity to
ask questions.
The most
important point to remember about
informed consent in any medical research
is that it is not simply a signature on
a document. Rather, informed consent is
an ongoing process of communication,
involving the patient and caregivers and
key members of their medical care team.
This guide will help you understand
the role of informed consent in the
research process, learn what to look for
in reading consent documents, and
provide tips for navigating through the
process.
Why It's Important
Informed
consent is the process which ensures
that clinical trials are conducted
ethically, without undue risk to the
participants. It is only one part of a
larger system of protections for people
who want to help researchers evaluate
new medical treatments, procedures and
prevention techniques.
The
consent system continues to evolve, with
ongoing efforts to increase the
readability of consent documents and the
embracing of new technologies, such as
the Internet, to communicate with
research participants and those who
might consider participating in clinical
research.
Process
The most important point to
remember about informed consent in any
medical research is that it is not
simply a signature on a document.
Rather, informed consent should be an
ongoing process of communication,
involving the patient and caregivers and
key members of their medical care team.
The Belmont Report outlines three
principles which are central to the
informed consent process:
-
Adequate information (generally
defined as what a “reasonable
person” would want to know in order
to make a decision)
-
Understanding of that information by
the participant
-
Voluntary consent by the participant
In
a sense, the informed consent process
begins while researchers are designing a
new trial. All research involving people
must be approved by a local
Institutional Review Board (IRB), a
group including both physicians and lay
people, before the research trial can
begin. The IRB is charged with ensuring
that the research trial meets all the
rules and regulations governing
protection of human research subjects,
and does not present undue risks to
participants. The IRB also reviews and
approves the informed consent document
for every trial, again ensuring that it
contains all the required information.
Details of the informed consent
process vary from institution to
institution, but participants should
generally expect the following:
An initial meeting with the research
team. At this time, prospective
participants receive the informed
consent document and its contents are
explained. This meeting could include
physicians, nurses, social workers,
patient representatives and/or a staff
psychologist. The information should be
presented to the participant logically
and at a comfortable pace. Remember, the
research team is there to answer any
questions and address any concerns.
Participants may want to bring along a
family member or friend for support and
to help take notes. In some cases, the
document may be supplemented with a
video, audiotape or interactive program
to aid in understanding the information.
Time to digest the information. The
informed consent document does not have
to be signed right away. If a copy of
the document is not made available, ask
for it. Take it home and review it as
many times as needed to completely
understand the information before making
a decision on whether to participate.
Assessment of understanding. The
research team should take active steps
to make sure the potential participant
understands the information. This could
be through a written questionnaire,
asking questions verbally, or asking the
participant to explain parts of the
document in their own words. If there is
anything you do not understand, or if
the document is written in words that
are too difficult for you, tell the
researchers.
Opportunities to
ask questions. Participants always have
the chance to ask questions at every
point in the process. Keep asking until
you have all the information you need to
make an informed decision.
Continuing updates. As the trial
continues, there may be new information
that could affect health, welfare or
willingness to stay in the study.
Participants may be asked to sign a new
informed consent document. Remember,
participants are always free to leave a
study at any time if new information
causes concern about continuing to
participate.
Myths and Facts
Informed
consent in cancer clinical trials can be
a daunting process; there are many
common misperceptions about informed
consent and clinical trials. Here are a
few, from the National Cancer Institute:
MYTH: Informed
consent is meant primarily to protect
the legal interests of researchers.
FACT: The purpose
of informed consent is to protect
participants by giving them information
that can help them make informed choices
about whether to take part in research.
It also makes you aware of your rights
as a participant. (link to Why Informed
Consent is Important)
MYTH: Signing the informed
consent document is the most important
part of the process.
FACT: Putting your signature on
an informed consent document is only
part of the process. The heart of
informed consent is a participant’s
ongoing interactions and discussion with
researchers and other medical personnel,
both during and after the study.
MYTH: My doctor knows
best; he or she can tell me whether I
should participate.
FACT:
You are the only one who can decide
whether to take part in a clinical
trial. Your doctor and the rest of the
care team are important and valuable
sources of information, but they can
only provide balanced information about
the risks and benefits of participation.
Remember, no one can predict whether the
treatment being studied will be
successful in your case.
MYTH: Once I sign the consent
form, I have to enroll and stay
enrolled.
FACT:
That is not true. You are free to change
your mind and not participate. You also
have the right to leave a clinical trial
at any time for any reason, without
giving up access to other treatment.
MYTH: I can't
really expect medical personnel to
listen to my questions or keep me
informed.
FACT:
The research team has a duty to keep you
informed and to make sure you understand
the information they provide and answer
any questions. You will be given the
name of a key contact person to stay in
touch with throughout the trial.
Remember, it is your willingness to
participate that makes clinical research
possible.
Informed
Consent Document
The
informed consent document is only part
of the informed consent process. The
document basically outlines the risks
and benefits of a clinical trial, going
into many specific details. It is part
of the materials reviewed and approved
by local Institutional Review Boards
before any trial can begin.
Federal regulations govern many of the
elements required in informed consent
documents, but there is no one standard
document. Over the last eight years, the
National Cancer Institute and other
groups involved in clinical trials, such
as the Eastern Cooperative Oncology
Group, have been working to help
researchers write comprehensive and
user-friendly consent documents. The NCI
has also developed a template and sample
forms that are used as models for
informed consent documents.
Consent documents vary from institution
to institution, however they should
contain all the following elements in
easy-to-understand language, based on
the NCI recommendations. If any of the
sections explained below are not present
in a consent document you are reviewing,
don't hesitate to ask for them.
Remember, according to federal
regulations, no informed consent
document may include language that asks
or appears to ask you to waive your
legal rights, or that releases or
appears to release the investigator,
sponsor or institution from liability
for negligence.
Also, remember
that you do not have to sign the
document immediately. You are entitled
to take as much time as needed to read
and understand the material.
It
may be helpful to print this
checklist outline.
Document Sections
Title
& Purpose
These sections give you the formal name
and code number of the trial and
describe the reason for it, such as
investigation of new treatments,
screening or supportive care. It also
outlines the study rationale, based on
previous research, and tells you which
phase the trial is in.
Description of Procedures
This section describes what will be
involved in the trial - the procedures
you will undergo, how frequently they
will take place and where they will take
place. For treatment trials, this should
include procedures that are part of
regular cancer care; standard
procedures, such as tests or scans,
being done because you are in the trial;
and procedures that the trial is
evaluating. If the trial is randomized
this section will outline how that
randomization will be done. In some
cases, researchers may also ask
permission to use tissue such as tumor,
blood, skin or urine as part of your
study or for future research.
Duration
This section indicates how long the
trial will last, including any long-term
follow up. It also outlines any
circumstances under which you might have
to stop participating in the trial. This
section only describes how long you will
participate in the trial, not how long
the entire trial will take. Your
treatment might last only a few weeks or
months, but a trial could last for
years, depending on factors such as the
total number of patients involved, how
quickly patients are recruited to
participate, and how long it takes to
analyze the results.
Risks
This section outlines both the
nonphysical and physical risks of
participating in a trial. Nonphysical
risks might include missing work, and
physical risks might include side
effects such as nausea, vomiting, pain
or susceptibility to infection. This
section should indicate the likelihood
of risks, how serious they might be,
whether they are more likely to be
short-term or long-term. It should also
include information about reproductive
risks, such as pregnancy, infertility or
the ability to nurse a child during the
trial.
Benefits
This section describes any benefits
which may reasonably be expected from
the trial. Remember, doctors cannot
guarantee any individual patient that
any treatment will improve or cure them,
whether or not it is part of a trial.
Alternatives to Participation
In
treatment trials, this section describes
what options you have for treatment
other than the trial, such as a standard
treatment or no treatment.
Confidentiality
This describes the extent to which your
information will be kept confidential.
It should also inform you about any
groups or organizations that might have
access to your records for quality
assurance and data analysis. This could
include the National Cancer Institute,
the Food and Drug Administration or
other trial sponsor.
Costs/Additional Expenses
This area of the document indicates
whether participating in the trial will
result in added costs for you or your
health insurer. It also outlines who
would pay for emergency treatment in
case of injury or illness, and whether
or not you will receive payment for
participating.
Participants' Rights
An
informed consent document should specify
that:
-
Your participation is voluntary
-
You can choose not to take part or
leave the trial at any time without
penalty or loss of benefits
-
Any new information that might
affect your participation will be
shared with you.
Contact Information
You
should have a contact name and
information, usually of a member of the
research team, if you have questions
about the study. You should also be
given contact information for the
Institutional Review Board or a patient
representative, if you have questions
about your rights as a research
participant.
Supplemental Information
This lists additional resources such as
NCI's Cancer Information Service,
informational booklets, community
organizations and Internet resources.
Signature
Your signature represents your legal
consent to participate in the trial.
When you sign the informed consent
document, you should receive a copy. If
not, ask for one. You may also request a
copy of the trial protocol, which is a
detailed medical document describing the
complete study plan.
Insurance
Current State of Coverage
Important Coverage Questions for
Employers
Insurance Coverage
Myths and Facts about Insurance Coverage
Payment Of The Routine Care Costs In
Cancer Clinical Trials
Current State of Coverage
Stakeholders in the cancer research
enterprise recognize the importance of
insurance coverage in increasing
participation in clinical trials. A
number of states and insurers are
working to ensure coverage of the costs
of routine care provided in cancer
clinical trials.
Routine care costs generally include
items that would typically be provided
to a patient if they received care
outside a clinical trial, such as
diagnostic procedures, office visits,
intravenous infusions, inpatient
hospital admissions. Costs associated
specifically with the trial, such as the
medication or treatment, testing
required to assess results and data
gathering activities, are most often
covered by the trial sponsor, and are
not considered part of routine care
costs.
Some states have enacted
laws requiring coverage of some or all
of the routine care costs involved with
cancer clinical trials, while others
have worked with insurers to develop
voluntary agreements. Some insurers also
have elected to cover clinical trial
costs independently of state mandates or
agreements.
On
the federal level, Medicare has covered
routine care costs for clinical trials
since 2000. The Department of Veterans
Affairs and Department of Defense have
also instituted coverage for routine
care costs.
These programs are constantly evolving
and are subject to change. An excellent
website for more information is the
National Cancer Institute site regarding
financial assistance for cancer care at:
http://www.cancer.gov/cancertopics/factsheet/Support/financial-assistance.
Important Coverage Questions for
Employers
The fear that
health insurance will not cover cancer
clinical trials is one of the foremost
barriers to increasing patient
participation in trials. In fact, as
many as 75-80 percent of claims for
payment on cancer clinical trials are
ultimately paid, according to a poll of
trial participants by Harris
Interactive. Companies can help their
employees by working with third party
payers to determine, in advance, whether
the routine costs of cancer trials are
covered. If your employees are armed
with this information before a cancer
diagnosis, they could be more receptive
to the idea of participating in a trial.
Here are some questions to ask
your company's current third-party
payer, or potential new insurers:
-
Do
your standard policies include
coverage for the routine costs of
care for cancer clinical trials?
-
Are there any restrictions on trial
sponsors or type of trials covered?
-
Is
precertification necessary?
-
Does a medical doctor review
requests/denials for coverage?
-
What type of paperwork are care
providers required to submit?
-
Are there any limitations on where
covered trials are conducted?
-
If
you do not cover the routine cost of
care in cancer clinical trials, why
not?
Insurance Coverage
No one is ever completely prepared to
face cancer. The emotional and physical
stress for patients and care givers is
tremendous. Among your worries may be
whether your insurance will cover cancer
clinical trials.
This section
includes resources that will help you
begin to understand that you have many
options regarding insurance coverage for
your treatment, and it will help dispel
some common misunderstandings about the
ability to receive coverage for cancer
clinical trials.
Myths and Facts about Insurance Coverage
One of the biggest barriers
to enrollment in cancer clinical trials
is patient fears that the cost of care
will not be covered, because trials are
experimental. In fact, according to a
recent survey of cancer trial
participants, about 86 percent had some
or all of their costs covered. Here's a
look at some of the myths about costs
and coverage of cancer trials, in hopes
that accurate information will help
increase participation.
MYTH: Clinical
trials cost more than standard cancer
treatment.
FACT:
Not necessarily. Studies by groups
including the American Association of
Cancer Institutes, Kaiser Permanente,
Mayo Clinic, and Memorial
Sloan-Kettering Cancer Center have found
that routine care for patients in trials
is comparable to costs for patients not
in trials.
MYTH:
Medicare does not pay for cancer
clinical trials.
FACT:
False. In 2000, Medicare began paying
for the costs of routine care in
qualified clinical trials. Generally,
cancer treatment and diagnostic trials
are covered if they are funded by the
National Cancer Institute,
NCI-Designated Cancer Centers, Cancer
Cooperative Groups or other federal
agencies that fund cancer research.
About 65 percent of cancer patients in
the U.S. are Medicare beneficiaries.
For up-to-date information on
Medicare and cancer clinical trials,
visit the federal
Centers for Medicare and Medicaid
(formerly the Health Care Financing
Administration)
MYTH: Clinical trials
test treatments of unknown safety and
efficacy.
FACT: Generally not. The large majority of
cancer patients are enrolled in Phase
III clinical trials, which compare the
outcome of two or more established
alternative treatments. Many of these
treatments are considered variations on
the current standard of care and are
routinely covered outside clinical
trials. Studies of treatments in the
early stages of human testing are
restricted to small networks of
institutions that are especially
qualified to conduct such studies.
Payment Of The Routine Care Costs In
Cancer Clinical Trials
Clinical trials are a crucial aspect of
a progressive health care system
offering the access to the highest
quality cancer treatment. Clinical
trials are the only way in which to
generate statistically valid health
outcome data. These data are crucial for
the development of new treatments,
establishing the relative efficacy of
existing treatment alternatives, and
elimination of outdated treatments.
Clinical trials offer patients access to
the latest treatments before these
become generally available and the
potential benefit from closer
surveillance and follow-up.
Currently fewer than five percent of all
adult cancer patients are treated in the
setting of a clinical trial despite the
benefits patients might realize through
their participation. This as compared to
60 percent of pediatric cases in the
U.S. and as much as a third of adult
cancer patients in Europe who are
treated in the setting of a clinical
trial.
Why participation in
clinical trials is so low among U.S.
adults has been addressed in a number of
studies. One concern that continues to
have a significant impact on the
behavior of patients and investigators
is the fear of denial of coverage by
third-party payers for treatment
provided in a clinical trial. But this
fear may be fueled as much by perception
as reality. Data from recent surveys
from the Summit Series on Clinical
Trials and the American Society of
Clinical Oncology indicate that as much
as 75 to 80 percent of claims for
treatment on a clinical trial are
ultimately paid. A study from the
University of California Davis Cancer
Center (Lara et al., Journal of Clinical
Oncology, vol 19, no. 6, pp1728-1733)
reported that insurance denial was the
cause of nonparticipation for only three
of the 276 patients in the study cohort.
In this study more common reasons for
nonparticipation were the physician not
considering the patient for
participation, a protocol appropriate
for the patient was not available, the
patient desired other treatment, and
distance from the clinic.
While
the survey and study data is encouraging
it does leave other concerns unresolved.
For example, the data indicates that
payment is denied for costs of routine
care in approximately one-fifth of
submitted cases but does not provide an
estimate of the magnitude of the number
of cases where a patient is treated on a
trial but a claim is not submitted (in
which case the patient or institution
must absorb the costs). Furthermore it
does not address the negative impact
that the pre-certification hassle factor
and payment delays can have on trial
participation.
The
Coalition of Cancer Cooperative Groups
is involved in national efforts to
address this and other problems. As the
leading voice in the cancer clinical
trials arena, the Coalition is involved
with numerous federal agencies and
national organizations in efforts to
streamline and improve the clinical
research process.
Myths vs. Facts About Cancer Research
Commonly held myths about research
participation may make some adult cancer
patients reluctant to participate in
clinical trials. Heartland is working to
help bring accurate information about
cancer research participation to the
general public in the region served by
its providers. For example: placebo or
placebo-based treatment is never given
to Heartland Clinical Trial
participants.
MYTH:
Research trials take place only at major
medical centers and teaching hospitals
in big cities. Anyone who does not live
near such a facility cannot take part in
research.
FACT:
The National Cancer Institute’s
Community Clinical Oncology Program
(CCOP) funds research at community-based
facilities in locations throughout the
country. Through CCOPs such as Heartland
Cancer Research, patients in many small
towns and rural communities are able to
participate in cancer research.
(Heartland Cancer Research partners
provide treatment and include patients
in research studies at facilities in St.
Louis County and in the rural Missouri
communities of Bonne Terre, Ste.
Genevieve, Sullivan and Washington.)
MYTH:
Research trials are only for terminal
patients whose cancers have not
responded to standard treatments and who
have no other options.
FACT: Some clinical
trials are intended for patients with
advanced cancers, who have exhausted all
other options for treatment. Many other
trials, however, are designed for
patients at varying stages of disease
and phases of treatment. Some modest
innovations in the treatment of advanced
cancers result in dramatic improvements
when they are applied to the management
of the earliest stages of cancer.
MYTH:
Being a research subject means that one
could be randomly assigned to a “control
group” receiving placebos (no
treatment), so researchers can make
comparisons.
FACT:
Patients in most cancer research studies
are assigned to standard treatment vs.
modified standard treatment groups. The
research goal is to compare approaches
to treatment to discover the best one,
not to compare treatment against no
treatment.
MYTH:
As a research subject, one may be viewed
as a statistic and not receive needed
attention from the medical team.
FACT: Subjects receive added
attention and information from
healthcare providers as a result of
being included in research, due to the
extensive monitoring and follow-up
required. A survey of cancer patients
participating in research indicated that
97 percent of respondents said the
quality of their care was excellent or
good, and that they were treated with
“dignity and respect.”
*
MYTH:
Insurers will not cover the cost of
treatment that is still at the research
stage.
FACT:
Large-scale medical research studies are
heavily regulated and evaluated by
funding organizations, so many insurers
will cover the costs of treatment
provided as part of a clinical trial. To
find out what insurance will cover,
cancer patients considering
participation in research should speak
with their medical team members and with
their insurance providers.
The production of meaningful cancer
research requires participation by
significant numbers of patients with the
disease. More than 75 percent of
pediatric patients with cancer
participate in clinical trials.*
Childhood cancer researchers credit the
high level of pediatric participation in
research with helping them produce many
positive outcomes. Since the 1970s, the
cure rate for childhood cancers has
improved from less than 10 percent to 75
percent.
Up to 85 percent of
adult cancer patients are treated
through community-based hospitals. Only
3-5 percent of adult cancer patients
participate in clinical trials. Up to
two thirds of the patients who are
invited to participate in research
trials decline to do so.
The
researchers at Heartland Cancer Research
provide cancer treatment at
community-based medical facilities in
St. Louis county and portions of
southeast Missouri. They believe it is
essential to help communities
surrounding these locations become well
informed about the importance of
participation by adult patients in
cancer research studies.
*
www.cancertrialshelp.org
**
A
Quantitative Survey of Public Attitudes
Toward Cancer Clinical Trials,” Harris
Interactive Survey, 2000.
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