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Clinical trials were once thought of as a last resort for people who had no further treatment options, but today in some cases, they can even be the first treatments for people with cancer . There are hundreds of potential new advances in prevention, detection, diagnosis, and treatment of cancer waiting to be studied. Yet, the search for a cure is being slowed due to the small number of adults who know that cancer clinical trials are an option and participate in them.
Childhood Cancer Treatment Sets the Example
One of the most heartening statistics in cancer research is the cure rate for children. In the past three decades, the cure rate has improved dramatically from less than 10 to 75 percent . This is because of medical advances made by clinical research. Today, over 60 percent of pediatric patients with cancer are enrolled in clinical trials, demonstrating the continued positive impact of research and the importance of expanding the participation rate for all other types of cancer. If more adults with cancer began to participate in research studies, we might see a similar increase in cure rates for them.
How Clinical Trials Get Approved
Government Approval
In the United States , the Food and Drug Administration (FDA) is responsible for making sure that new drugs are safe and effective before they are marketed to the public. The FDA must approve all new drugs based on a complete analysis of the results of clinical studies which prove that the drug works. Drugs that are already approved which will be used in new ways must also be approved by the FDA. The FDA also enforces standards for conducting studies. Clinical trials must prove that a drug works before it is approved for use. Since these drugs are not yet on the market, cancer patients have an opportunity to use a new treatment—often many years before it is generally available to the public. If you participate in a study and the new treatment is proven effective, you will be among the first people to benefit from it.
Clinical Trial Sponsors
It’s a long road from development to FDA approval. Most products must first go through 12 to 15 years of careful research by the pharmaceutical industry to assure safety and effectiveness. Three phases of clinical trials are conducted before the FDA will grant approval to make a new drug available for general use. Currently, there are over 1,800 government-sponsored clinical trials underway plus countless trials sponsored by pharmaceutical companies.
Sponsors offer clinical trials in hospitals, cancer centers, community based clinics, and doctors' offices across the United States and in other countries. Some trials are offered in several locations, while others might be available in just one place. Many trials are sponsored by the National Cancer Institute ( NCI ) through a number of ways:
- NCI Designated Cancer Centers
- The Department of Defense—through a system called the Clinical Trial's Cooperative Group Program
- The Community Clinical Oncology Program (CCOP) 12 . CCOP helps community physicians take part in clinical trials. Minority-based CCOPs have been established specifically to address the needs of the minority population and to encourage participation in cancer prevention and control clinical trials.
- The Veteran's Administration—has an agreement with NCI which allows eligible veterans of the armed services to participate in NCI sponsored trials 13 . For more information, click here.
- Pharmaceutical companies—it is more difficult to find information about the trials sponsored by pharmaceutical companies.
For more information on how clinical trials work, visit Cancer Care’s web site.
Clinical Trial Phases
Once a new treatment has been tested in the laboratory and is proven safe for humans, clinical trials begin. Each trial phase is designed to answer specific questions about the treatment.
PHASE 1
Phase I trials establish the safest dosage and best way to take the drug, and they measure any side effects, or toxicities, of the treatment. They involve a small number of volunteers, usually 20-80. Most Phase I trials use healthy volunteers, however, since cancer drugs often destroy normal cells as well as cancer cells, cancer studies usually involve cancer patients who have not benefited from standard therapies. Phase I clinical trials do not focus on a specific disease state or tumor type.
PHASE II
Phase II trials look at the effectiveness of the treatment against a specific tumor type of disease state and continue to examine safety and side effects. Often, 150-300 patients participate and typically they are patients who have tumors or cancer lesions that can be measured before and after treatment. According to the National Cancer Institute, only one-third of the drugs assessed in Phase II trials are found safe and effective enough to go on to the next phase.
PHASE III
Phase III trials test the effectiveness of a new drug, combination of drugs, or procedure. Unlike the first two phases, Phase III trials require a large number of participants. In cancer studies, patients are not given a placebo, or inactive drug. In studies for cancer drugs, the patients are randomly assigned to receive either the current “gold” standard treatment, which is the best treatment available, or the new treatment. The two treatments are compared for effectiveness. As part of informed consent, patients will receive continual updates on the progress of the trial. If the experimental treatment is not working, patients may choose to leave the trial and take the standard treatment.
PHASE IV
Phase IV trials test a drug that is already marketed and available for possible new uses. Phase IV studies also test new dosages and ways of giving the drug.
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