In order to one day find a cancer cure, doctors engage in clinical trials where they test new drugs to determine if they are effective.
Clinical trials follow a plan of very strict scientific guidelines, which is called a protocol. The protocol explains everything that will happen in the study. It must be approved by review boards made up of health care professionals and other qualified people before the study can enroll patients.
When a potential drug is first identified, preclinical studies, which are conducted in a laboratory setting, help to find out whether the drug is safe to test in humans. During this stage, the drug is usually studied in animals to answer questions about how a drug works and how the body changes and disposes of it. Humans do not participate in preclinical studies. There are four possible phases of cancer clinical trials in humans, each designed to answer different questions about the treatment being studies.
In Phase I clinical trials, doctors are primarily studying the safety of giving new drugs to humans, while also looking for the best way to give a medication (for example, as a pill, an injection, or an infusion). They will usually study how the drug is eliminated from the body in humans. Also, doctors are trying to find the right doses for further testing. They carefully watch for any side effects. Phase I study drugs are usually given to small groups of humans. During this phase, for drugs used to treat cancer, investigators may be able to find out which tumors a treatment works best in.
In Phase II clinical trials, the drug is studies in a larger group. The primary purpose of these studies is to see how well the drug or treatment shrinks tumors in patients with specific types of cancer. The investigator will watch closely for side effects and will also watch how the disease responds to the treatment.
In Phase III clinical trials, the new cancer treatment is generally compared to a standard existing treatment. Patients are usually randomly assigned (that is, a process similar to flipping a coin is used to determine which treatment the patient receives) to receive either a standard treatment or the new treatment.
During the trial, patients may or may not be told which treatment they are getting but are told what to expect and what to watch for. Occasionally, even the doctor will not know which treatment each patient is getting so that he or she can remain unbiased about how the disease is responding to the treatment. (This is uncommon in cancer clinical trials). Phase III studies are designed to ensure that any side effects that patients experience are identified treated according to local standards of care.
Phase IV clinical trials study a drug that has already been approved by the Food and Drug Administration. Drug companies often sponsor these trials to study even more uses of drugs already available.
Patients battling lung cancer now have a new tool to aid them in making treatment decisions. The National Comprehensive Cancer Network (NCCN), in conjunction with the American Cancer Society, recently announced the release of its Lung Cancer Treatment Guidelines for Patients.
The NCCN Treatment Guidelines for Patients are a companion to the NCCN Clinical Practice Guidelines in Oncology used by physicians making treatment decisions. The guidelines provide the most up-to-date information about treatment options and are written in easy-to-understand language. Among the topics covered are: types of lung cancer, tests and exams, types of treatment, clinical trials information, and a helpful glossary of lung cancer terms.
Patients also are provided with the same decision trees used by their doctors. These flow charts represent the appropriate course of treatment for each stage of specific types of lung cancer.
The guidelines are available free of charge on the NCCN's web site and by calling toll free at 888.909.NCCN.