Clinical trials for cancer are research studies specifically targeted for cancer patients. Cancer clinical trials are designed to find new ways to find, diagnose, treat, prevent, and manage cancer. Many of the treatments used today are results of past clinical trials. Through clinical trials, researchers can determine whether new treatments are safe and effective, or if they work better than current treatments. Without clinical trials, new drugs and cancer treatments could not be approved. Most advancements in cancer treatment throughout recent years came from a clinical study.

Types of Clinical Trials

Each type of trial is designed to answer different research questions about cancer. There are several types of trials:

• Treatment Trials
  
These trials test new treatments or new ways to use existing treatments. All treatment trials involve people who currently have cancer. These trials can include new drugs, vaccines, and approaches to surgery, radiation, or a combination of these. One type of treatment trial involves testing cancer cells for the presence of specific molecular markers, which include changes in certain genes or proteins. These changes can help further classify cancer and the treatments that may target them.
• Prevention Trials
  Prevention trials are studies involving healthy people. In most cases, the participants either don’t have cancer but are at high risk for developing the disease, or have previously had cancer and are at high risk for developing a new cancer. Prevention trials look at cancer risk and ways to reduce that risk.
• There are two types of prevention trials:
  • Action studies focus on looking at actions people take, such as exercising more, and if that can prevent cancer
  • Agent studies focus on looking at certain medicines, vitamins, minerals, or dietary supplements to see if they may lower the risk of specific cancers. These studies are also called chemoprevention studies.
• Screening Trials
  These trials test ways to find the disease early, when it may be more easily treated. Effective screening tests will reduce the number of deaths from the cancer being screened. Researchers use screening trials to find if early detection of cancer, before any symptoms, can save lives.
• Palliative Care Trials
  These trials find new ways to help people cope with pain, nutrition problems, infection, nausea, sleep disorders, depression, and other health problems related to cancer. Palliative trials look at ways to improve the quality of life of cancer patients, especially those suffering from side effects of treatments. Some palliative trials include testing activities, such as exercising, attending support groups, and talking with a counselor.

Phases of Clinical Trials

All clinical trials involve a series of steps, or phases, to test cancer treatments. If the treatment is successful in one phase, it advances to further testing in the next phase.

• Phase I: Safety
  
Phase I trials look to decide how a new treatment should be given, how the treatment affects the human body, and how large a dose is safe. Generally, this phase is intended to determine the maximum tolerated dose and toxicity, not to show effectiveness of the treatment. These trials are generally conducted at tertiary centers.
• Phase II: Effectiveness
  The second phase looks to determine if the new treatment has an effect on certain cancer, and how that treatment affects the body. Researchers are looking at the response rate to the treatment, i.e. the reduction in size of measurable tumors. To qualify for Phase II trials, you must have advanced cancer and have tried the standard therapy for your disease, if there is any. Southeastern Medical Oncology conducts such trials.
• Phase III: Comparing Treatments
  Phase III’s purpose is to compare treatments. Typically, a standard treatment is being compared to an experimental treatment. In this stage, patients are randomly assigned one of the treatments being studied. Randomization is important to the scientific validity of the research, but may mean a patient receives the standard treatment as opposed to the new treatment. Southeastern Medical Oncology conducts such trials.
• Phase IV: Long-Term Studies
  These trials look at the long-term safety and effectiveness of treatments. These trials take place only after a new treatment has been approved and is on the market. They may monitor the use of drug treatments in different populations, or test quality-of-life variables.

Should You Participate?

Deciding to participate in a cancer clinical trial is a huge decision that belongs only to you, the cancer patient. Some things to consider when deciding on clinical trials are your views on scientific evidence, feelings about your disease, and personal attitudes about health. Research is the best way to start figuring out if clinical trials are right for you, along with discussing the issue with your doctor and family. Trials are not for everyone, so it is important you consider all aspects of the studies. Here are some pros and cons to consider:

Pros

• Care from doctors who are leading cancer specialists
• Access to new drugs that may not be otherwise available
• Trials help others patients and possibly the future of cancer treatment
• Trials advance scientific knowledge of cancer

Cons

• The risk of side effects
• You may not be able to choose treatment in trials like Phase III where treatments are randomly assigned
• Your health insurance plan may not cover the study
• Clinical trials may require more time than standard treatment

If you are considering participating in a clinical study, be sure to consult with your physician. Your doctor can recommend trials and answer any additional questions about side effects, benefits, costs, and quality-of-life.

Source:
The National Cancer Institute at the National Institutes of Health