Skip Navigation Links
   
Skip Navigation Links
   

Clinical Trials Information

Welcome to Heartland CCOP Cancer Research St. Louis, MO

 

 

Clinical Trial Questions/Answers
Frequently Asked Questions about Clinical Trials

Informed Consent
Documents regarding informed consent

Insurance Questions
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? Man and Woman Pills
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?

  1. 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.
     
  2.  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.
  1. 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 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 Translational Research Program (TRP) 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 Community Clinical Oncology Program (CCOPs) 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.
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  1. 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.
  1. 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.
  1. 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 here 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 States Requiring Coverage of Clinical Trial Costs - National Cancer Institute 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.

  • 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.

  • 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.
  1. 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?
  1. 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.

  2. 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. 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 of Participation

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.

Clinical Trial 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 Questions

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/coping/financial-legal

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.

 
 

All contents 2007 Heartland Cancer Research St. Louis, MO. All rights reserved. Privacy Policy