Click Here to find a Clinical Trial
Click here to view a video explaining Karmanos’ Phase I Clinical Trials Program.
Many cancer patients are eligible for and encouraged to consider participating in clinical trials. These are studies widely-believed to be among the best options for most cancer patients. They seek to answer questions that we hope and expect will lead to better ways of preventing, diagnosing and treating cancer. Or they are designed to improve the quality of life for patients.
The Institute conducts more than 300 clinical trials. Many are developed by our own physicians and researchers. The Institute is also a major contributor to several national clinical treatment programs including the Southwest Oncology Group (SWOG), the Children's Oncology Group (COG), the Radiation Therapy Oncology Group (RTOG) and the Gynecologic Oncology Group (GOG).
What is a Clinical Trial?
A clinical trial is a research study that evaluates new approaches to the prevention, diagnosis and treatment of cancer, as well as quality of life/patient comfort, behavioral, psychosocial (the impact of cancer) and genetic questions that researchers would like to answer.
They involve human participation. Without this participation, the study may conclude without definitive answers. Clinical trials are sometimes called “clinical studies,” “research protocols” and “medical research.”
A clinical trial is one of the stages of a long and careful cancer research process. Getting promising results from testing a new drug on mice, for example, is a preliminary step to human research studies. Treatments that work well in mice do not always work well in people.
What are the Different Types of Clinical Trials?
Treatment trials test new treatments – such as a new cancer drug, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy.
Prevention trials test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer. These trials look for the best way to prevent cancer in people who have never had cancer or to prevent cancer from coming back or preventing future cancers in people who have already been diagnosed.
Screening and diagnostic trials test the best way to find cancer, especially in its early stages, and methods of “imaging” it during or after therapy to help physicians and patients in treatment decisions.
Quality of Life trials (also called Supportive Care trials) explore ways to improve comfort and quality of life for cancer patients.
What are the Purposes of Clinical Trials? Why are They Important?
The purpose of all clinical trials is the same: to determine whether a new approach is more effective than current ones in the prevention, early detection and treatment of cancer, and the quality of life for persons diagnosed. Today's standards of care were yesterday's clinical trial.
Today’s clinical trials lead to tomorrow’s standard care. They are necessary to identify more effective interventions before they can be offered to other persons. Advances in medicine and science result from new ideas developed through research. Clinical trials help scientists develop improved treatments and sometimes lead to cures. The participants, themselves, stand to benefit first from the study.
In some cases, there may be no equivalent "standard of care" such as instances of rare or advanced cancers.
Where do Clinical Trials Take Place?
They are underway throughout the country: in cancer centers, other major medical centers, community hospitals and clinics, physicians' offices and veterans' and military hospitals in numerous cities and towns around the United States.
What Types of Cancer Treatments are Studied in Clinical Trials?
Scientists may study ways to prevent, diagnose and treat cancer. They may also measure the psychological impact of the disease and determine ways to improve a patient’s comfort and quality of life. Most clinical trials study new treatments or they compare different sequences, combinations and dosages of therapies. They are studied alone or along with surgery, radiation therapy, chemotherapy, gene therapy, immunotherapy, or newer types of therapies.
Are Clinical Trials Safe?
Risks and side effects exist with standard care or a clinical trial. However, many safeguards are in place to make clinical trials as safe as possible and protect patients. Before a human being ever receives a new therapy, it is carefully studied in the laboratory. Laboratory research determines how best to use the new methods with people safely and effectively. Any research involving people at the Barbara Ann Karmanos Cancer Institute must be approved by the Institutional Review Board (IRB). The IRB is made up of doctors from different specialties, ethicists (often a chaplain), administrators, and members of the public. An IRB is required by the U.S. Food and Drug Administration (FDA) to ensure protection of the rights and welfare of patients who are enrolled in clinical trials. Therefore, the IRB is authorized to review, require changes to, approve, or disapprove studies.
Through a process called informed consent you will learn about a study's treatments and tests, and possible benefits and risks, before deciding whether or not to participate.
Patients on clinical trials are carefully monitored. Blood tests, x-rays, and other procedures are performed regularly to detect and record any changes, good or bad, in the patient’s condition. The monitoring provides physicians and scientists with valuable data for making patient care decisions and for documenting research results.
Are Placebos Used in Clinical Trials?
Placebos (sometimes called “sugar pills”) are commonly used in prevention studies in order to determine whether an intervention is effective in preventing the disease from occurring or returning. Using a placebo is the only way to determine whether the actual intervention – and not the participant’s perception of participating – is effective. In treatment trials – that is, studies involving people who have cancer – placebos are very rarely used.
Who is Eligible to Participate in a Clinical Trial?
Each study has its own guidelines for who can participate. Generally, participants are alike in key ways – such as the type and stage of cancer, age, gender and other factors.
What are the Phases of Clinical Trials?
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Clinical trials are usually classified into one of three phases:
Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.
Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.
Who pays for the patient care costs on clinical trials?
Health plans and managed care providers do not always cover all patient care costs in a study. What they cover varies by plan and by study. Ask a doctor, nurse or social worker from the study to help you determine in advance what costs are covered. The research costs, such as data management, are covered by the study sponsor.
For More Information
- Click here to find a Clinical Trial.
- Speak with your physician.
- Call (800) KARMANOS (1-800-527-6266) or e-mail info@karmanos.org.
- Call (800) 4-CANCER (1-800-422-6237), the National Cancer Institute's Cancer Information Service, or visit its website: www.cancer.gov.
- Oncology by Oncologystat.
