Cancer-Related Clinical Trials
We want you to be well informed about your cancer diagnosis and clinical trials related to your diagnosis that may be available. Clinical trials – research studies in people – show us what works (and doesn’t) in medicine. Choosing whether or not to take part in a clinical trial is a very personal and sometimes difficult decision. Clinical trials are not just for patients that feel they have exhausted all other treatment options – they are for patients that want to explore new treatments and help in the determination of how safe and effective they are.
The Hope Center, a service of Cartersville Medical Center and the American Cancer Society would like to invite you to call the American Cancer Society at 1-800-ACS-2345 or visit their web site at www.cancer.org to learn about cancer-related clinical trials and the ACS clinical trials matching service.
Twenty-four hours a day, seven days a week, the American Cancer Society is available to share information with you. An American Cancer Society staff member will share information about clinical trials with you over the telephone or you can visit the American Cancer Society web site, type in “clinical trials matching” in the search box and explore the opportunities at your convenience. Learn what clinical trials are and find out what clinical trials may be a good match for you.
Knowing about and understanding the benefits of cancer-related clinical trials will help you make an informed decision about whether participation in a clinical trial would be a good option for you. Learn more about such trials and discuss this information with your health care provider. Together you will develop the best cancer care treatment plan for you and your current health status.
Additional web sites containing information about clinical trials are listed below:
Understanding Clinical Trials – An Introduction for Patients
What Is a Clinical Trial?
Clinical trials are studies that evaluate the effectiveness of new interventions. There are different types of cancer clinical trials. They include:
- prevention trials designed to keep cancer from developing in people who have not previously had cancer;
- prevention trials designed to prevent a new type of cancer from developing in people who have had cancer;
- early detection trials to find cancer, especially in its early stages;
- treatment trials to test new therapies in people who have cancer;
- quality of life studies to improve comfort and quality of life for people who have cancer;
- studies to evaluate ways of modifying cancer-causing behaviors, such as tobacco use.
So, depending on what is being studied, a particular clinical trial may involve patients with cancer or people who do not have cancer but are at higher risk than most people for developing it. If you take part in a clinical trial, you may benefit from a new drug, procedure, or symptom-control method while helping scientists evaluate its effectiveness. Your participation may also contribute directly to finding better ways to prevent, detect, or treat the disease. Many of today's most effective interventions are the direct result of knowledge gained through clinical trials.
What Are the Phases of Clinical Trials?
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps. This allows researchers to ask and answer questions in a way that expands our information about the drug and its effects on people. Based on what has been learned in laboratory experiments or previous trials, researchers formulate hypotheses or questions that need to be answered. Then they carefully design a clinical trial to test the hypothesis and answer the research question. It is customary to separate different kinds of trials into phases that follow one another in an orderly sequence. Generally, a particular cancer clinical trial falls into one of three phases.
Phase I Trials
These first studies in people evaluate how a new drug should be administered (orally, intravenously, by injection), how often, and in what dosage. A Phase I trial usually enrolls only a small number of patients.
Phase II Trials
A phase II trial provides preliminary information about how well the new drug works and generates more information about safety and benefit. Each Phase II study usually focuses on a particular type of cancer.
Phase III Trials
These trials compare a promising new drug, combination of drugs, or procedure with the current standard. Phase III trials typically involve large numbers of people in doctors' offices, clinics, and cancer centers nationwide. If you participate in a Phase III treatment trial, you are likely be randomized (assigned by chance) to a group receiving either the new intervention or the standard intervention. Trials designed in this way are also called randomized controlled trials. If you are assigned the standard intervention, you receive what experts view as the best treatment available in the realm of routine medical practice. If you are assigned the new intervention, you receive a treatment that some experts think may have significant advantages over the standard. The reason that the clinical trial has been initiated is that the superiority of one treatment over the other has not yet been firmly established.
Phase IV
Some use the term Phase IV to include the continuing evaluation that takes place after FDA approval, when the drug is already on the market and available for general use (post-marketing surveillance).
Some supportive care, prevention, and screening trials are not done in phases, but instead compare groups of people using a certain anticancer strategy (counseling, behavior change, detection method) with those who do not.
What is a Clinical Trial Protocol?
Clinical trials follow strict scientific guidelines. These guidelines deal with many areas, including the study's design, who can be in the study, and the kind of information people must be given when they are deciding whether to participate. Every trial has a chief investigator, who is usually a doctor. The investigator prepares a study action plan, called a protocol. This plan explains what the trial will do, how, and why. For example, it states:
- how many people will be in the study.
- who is eligible to participate in the study.
- what study drugs participants will take.
- what medical tests they will have and how often.
- what information will be gathered.
Every research center that takes part in the trial uses the same protocol. This ensures that information from all centers can be combined and compared.
Where are Trials Conducted?
If you were to participate in a clinical trial, you might receive your treatment at a large cancer center, a university hospital, or your local medical center or physician's office. Clinical trials are also conducted at the National Cancer Institute on the campus of the National Institutes of Health in Bethesda, Maryland.
Depending on the type of trial and on the approach being studied in it, the trial may be treating participants at one or two highly specialized centers or at hundreds of locations at the same time. You would follow the trial's protocol under the guidance of a team including your physician, an oncology nurse, or other health professionals, who would report your experience with the treatment back to the center responsible for the trial's overall coordination. Experts could then use the information from all the participants to evaluate the new treatment, screening method, or preventive measure under investigation.
Who Can Participate in a Trial?
Clinical trials enroll people who are alike in certain ways depending on the study's purpose. Every protocol identifies some specific characteristics that the people should have in order to participate in the study. These characteristics are called eligibility criteria. They may include the type of disease and its stage, age and general health.
Eligibility criteria are a key part of medical research. They help assure that the study results answer the research question. They also help doctors identify who will benefit in the future from the approach being studied if it's shown to work. For example, in cancer prevention studies, a new drug may work for people with one type of risk factor but not for another.
Eligibility criteria also help insure safety of participants by protecting them from known risks. For example, some drugs can only be given safely if a person has normal kidneys or liver. In this situation only persons with normal kidney or liver function are allowed to participate.
How Are Trial Participants Protected?
Clinical trials have several procedures to protect the safety of the people who participate. One or more review groups have to approve the protocol for every study. Two of those groups are the organization that sponsors it (for example, the National Cancer Institute) and the Institutional Review Board (IRB) that oversees clinical research in the health-care institution.
Every study center has an IRB, which includes doctors, other health care providers, consumers, and sometimes members of the clergy. IRB members do not have any personal interest in the results of the study. They serve as neutral reviewers, ensuring that the study is conducted fairly and that no one who decides to become a participant is likely to be harmed. Each Phase III trial also has a special group called a Data Safety and Monitoring Committee that looks at the test results, monitors the safety of the participants, and decides whether the study should go forward as originally planned.
Where Do the Ideas for Trials Come From?
The ideas for clinical trials often originate in the laboratory. Researchers develop a clinical protocol (the action plan) for a trial after laboratory studies indicate the promise of a new drug or procedure. Initial trials in people focus on feasibility and safety. As researchers gain further experience, later trials then seek to determine whether the new approach benefits people and whether it has advantages over standard approaches currently in use.
Who Sponsors Clinical Trials?
Clinical trials are sponsored by organizations or individuals who are seeking to discover better interventions to improve health care. It is the responsibility of the sponsor to see to it that a clinical trial is conducted in a scientifically sound and ethical manner in accordance with all laws and regulations.
The interventions being studied can be a new drug or device for treating or preventing disease, or a new diagnostic method for detecting or diagnosing a disease early. Pharmaceutical companies or companies that manufacture diagnostics devices, like X-ray equipment, sponsor trials of their products, in the hope of demonstrating that their products are safe and effective for their intended use. Once this is done, the Food and Drug Administration (FDA) will permit companies to sell the drug or device and advertise it for the intended use. In this way clinical trials serve the very important function of helping to assure that the drugs and devices offered to people for their standard care are, in fact, safe and effective for these purposes. The National Cancer Institute sponsors a large number of clinical trials in the areas of prevention, diagnosis and detection, and treatment. Finally, individual physician-investigators at cancer centers and other health-care institutions can sponsor clinical trials themselves.
Clinical Trials Sponsored by the National Cancer Institute (NCI)
The NCI has a number of programs designed to make clinical trials widely available in the United States. Thousands of investigators at over a thousand sites participate in various aspects of NCI's clinical trials programs. These include the following:
Cancer Centers Program
More than 45 research-oriented institutions have been designated as NCI Comprehensive or Clinical Cancer Center for their scientific excellence. Located throughout the country, they play an important role in cancer research, in delivery of the highest quality cancer care, and in outreach and education of both the general public and health-care professionals. The centers are key partners in the NCI's efforts to bring the benefits of clinical research directly to you. When an institution meets the rigorous competitive standards of an NCI Cancer Center, it is awarded a Cancer Center Support Grant, which allows the center to coordinate multidisciplinary approaches to research questions, to gain access to cutting-edge technologies, and to take rapid advantage of new research opportunities.
The Cooperative Clinical Trials Program
This program knits together groups of academic investigators, cancer centers, and community physicians into an NCI- supported network of national scope. The network consists of a number of consortia (cooperative groups) that seek to define the key unanswered questions in cancer and then conduct high-quality clinical trials to answer them. This kind of cooperation makes it possible to have central administration and data collection for trials taking place at a large number of sites all over the country. In the area of cancer treatment, the cooperative groups place approximately 20,000 new patients on clinical trials each year. These are principally the large Phase III randomized trials that help establish the state of the art for cancer therapy. In addition, the groups cordinate and perform large trials in cancer prevention.
The Community Clinical Oncology Program (CCOP)
This program makes clinical trials available in a large number of local communities in the United States by linking community physicians with researchers in cancer centers. Local hospitals thoughout the country affiliate with a cancer center or a cooperative group. This enables doctors to offer people participation in clinical trials more easily, without having to travel long distances or leave their usual caregivers. Several of these programs focus on encouraging minority populations to participate in trials.
Evaluating the Results of Clinical Trials
When a clinical trial is completed, the researchers analyze the data.
If the new strategy has proven promising and feasible in early (Phase I) studies, it moves to the next phase of investigation.
If the strategy has proven safe and effective in a definitive Phase III trial, the next step is to get the word out to the medical community and to the general public.
Usually a trial's results are first reported in a medical journal to bring the new approach to the attention of doctors and researchers. Most journals have in place a process of peer review, in which experts critique the report before it is published, to make sure that the analysis and conclusions are sound. Particularly important results are likely to be featured by the print or electronic media, and widely discussed at scientific meetings and by patient advocacy groups. Once an intervention is proven safe and effective in a clinical trial, it may become the new standard of practice. In this way the development of better interventions for prevention, for treatment, or for
detection and diagnosis is an ongoing, continuous process that builds progressively on itself to improve the quality of cancer care and prevention available to us all.
This information was provided by the NCI. More information about the National Cancer Institute is available on their web site at www.nci.nih.gov or by calling 1(800) 4-CANCER.
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