A clinical trial is one of the final stages of a long and careful cancer research process. Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective.

Treatment trials test new treatments (like a new cancer drug, new approaches to surgery or radiation therapy, new combinations of treatment, 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 a new cancer occurring in people who have already had cancer.
Screening trials test the best way to find cancer, especially in its early stages.
Quality of Life trials (also called Supportive Care trials) explore ways to improve comfort and quality of life for cancer patients.

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 dosage 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 trials 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.

The ideas for clinical trials often originate in the laboratory. Researchers develop a clinical trial protocol (a plan for a trial) after laboratory studies indicate the promise of a new drug or procedure. The first trials of a particular drug or procedure are focused on safety (Phase I), and later trials focus on whether the drug or procedure is effective (Phase II or Phase III).

Every trial has a person in charge, usually a doctor, who is called the protocol chair or principal investigator. Phase I and Phase II studies generally refer to the person in charge as the principal investigator. Phase III studies generally have a protocol chair, under whose direction multiple principal investigators carry out the protocol in participating sites. The protocol chair or principal investigator prepares a plan for the study, called a protocol. The protocol explains what the study will do, how it will be carried out, and why each part of the study is necessary. For example, the protocol includes:

• The reason for doing the study
• How many people will be in the study
• Who is eligible to participate in the study
• What study drugs the participants will take, if any
• What medical tests they will have, if any, and how often
• What information will be gathered

Every doctor or research center that takes part in the trial uses the same protocol. This ensures that patients are treated identically, and that information from all the participating centers (if there are more than one) can be combined and compared.

Clinical trials are sponsored by organizations or individuals who are seeking better treatments for cancer or better ways to prevent or detect cancer.

Individual physicians at cancer centers and other medical institutions can sponsor clinical trials themselves.

The National Cancer Institute (NCI) sponsors a large number of clinical trials. 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 program. These include:

• Cancer Center Program: About 60 research-oriented institutions have been designated as an NCI Comprehensive or Clinical Cancer Center for their scientific excellence. The centers are key partners in the NCI’s efforts to bring the benefits of clinical research directly to you. Located throughout the country, they play an important role in cancer research, delivery of the highest quality cancer care, and outreach and education for the public and professionals.
• Cooperative Clinical Trials Program: This program brings together groups of researchers, cancer centers, and community physicians into a national NCI-supported network. The network consists of a number of Cooperative Groups that seek to define the key unanswered questions in cancer and then conduct high-quality clinical trials at many sites around the country to answer these questions. The Cooperative Groups enroll about 20,000 new patients in treatment trials each year. Important Phase III trials run by the Cooperative Groups help establish the state-of-the-art for cancer therapy. Additionally, the Groups perform large cancer prevention trials.
• The National Cancer Institute Community Oncology Research Program: 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 throughout the country affiliate with a cancer center or a Community Oncology Research Program. 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. The Nevada Cancer Research Foundation (NCRF) NCI Community Oncology Research Program has been funded by the National Cancer Institute since 1994. The LHMCC has been a part of a community clinical oncology program since 2007.