Where can people find more information about clinical trials?
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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). 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.
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What happens when a clinical trial is over?
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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.
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What are some questions people might ask their health care provider before entering a clinical trial?
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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?
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What are some of the possible risks associated with taking part in a clinical trial?
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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.
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What are some of the benefits of taking part in a clinical trial?
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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.
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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.
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How are clinical trials conducted?
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Clinical trials are usually conducted in a series of steps, called phases. Treatment clinical trials listed in PDQ®, 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 trials 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.
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What are the types of clinical trials?
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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.
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What is the role of the FDA in approving new drugs & medical treatments?
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The Food and Drug Administration's job is to make sure medical treatments
are safe and effective for people to use. However, FDA does not develop new
therapies, or conduct the clinical trials to demonstrate safety and effectiveness.
FDA staff members meet with researchers, and perform inspections of clinical
trial study sites to protect the rights of participants and to verify the quality
and integrity of the data.
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What should people think about before joining a clinical trial?
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People should learn as much as possible about the clinical trials that interest them. They should also feel comfortable discussing their questions and concerns with members of the health care team. Prospective participants should understand what happens during the trial, the type of health care they will receive, and any costs to them - which may or may not include the cost of the product, costs associated with administering the product, etc.
Anyone considering a clinical trial should also know that there are benefits and risks associated with participating.
Potential Benefits
Participating in well-designed and well-executed clinical trials is one approach for eligible patients/volunteers to:
* get actively involved in their health care.
* gain access to potentially new research treatments
* have access to expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied.
* help others by contributing to medical research.
Possible Risks
There are generally known and unknown risks associated with clinical trials, such as:
* there may be unpleasant, serious, or even life-threatening side effects resulting from the treatment.
* the treatment may not be effective for the participant.
* the protocol may require more of the participant's time and attention than a standard treatment. (Participants may need to visit the study site on a regular basis, be subjected to additional tests, get more treatments than are normally necessary, stay in the hospital and/or follow complex dosage requirements.)
Other considerations:
Payment/compensation:
* Subjects are sometimes paid for their participation in research, especially in the early phases of investigational drug, biologic or device development. Payment to research subjects for participation in studies is considered a a recruitment incentive. Financial incentives are most often used when health benefits to subjects are remote or nonexistent. Volunteers may be offered compensation in certain trials for their time, and for discomfort that may be experienced during the trial. The amount of compensation is determined by the amount of time you will be required to dedicate to the trial, and to the level of discomfort that might be associated with medical or surgical procedures related directly to the study. Payment information, including the amount and schedule of payment(s), as well as any possible costs to volunteers who participate in a study, are discussed with potential participants during the informed consent process, and documented in the informed consent form.
Potential Conflict of Interest:
* Some health care workers are paid fees for recommending, referring, or enrolling patients in clinical trials. This information is generally not discussed during informed consent, but potential volunteers may ask if the referring health care provider will receive monetary compensation, or if investigators have other potential conflicts of interest.
Continued Treatment:
* Will the treatment be stopped at the end of the trial, even if the participant feels it is beneficial? Some sponsors continue to provide product. Others do not.
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Are clinical trials safe?
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The FDA works to protect participants in clinical trials and to ensure that people have reliable information as they decide whether to join a clinical trial. The federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks.
Although efforts are made to control the risks to clinical trial participants, some risks may be unavoidable because of the uncertainty inherent in medical research studies involving new medical treatments.
The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Participants must sign an "informed consent" document before joining the study indicating they understand that the trial is research, and that they can leave the clinical trial at any time. This informed consent is part of a process that ensures a prospective participant in a clinical trial understands what known risks might be associated with the study, and whether there are potential, but as yet unknown risks that may be associated with the product being studied. This information permits someone deciding whether or not to enter a clinical trial to make an informed decision about the level of risk they are willing to accept before they enter the trial.
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