Clinical Trials

The goals of clinical cancer research are to improve the therapeutic outcomes for cancer patients and to improve the quality of care. Potential new agents that might be effective against cancer are tested using a process known as clinical trials. The process of developing new drugs that might be effective against cancer is a long and expensive process. The process begins with basic research, including screening of known chemical compounds. First, screening is done on potentially useful compounds using animal or human cancer cells grown in vitro. Next, animal toxicology studies and other studies are conducted to gather vital information about substance’s metabolism, half-life, absorption, excretion, and clearance. After this process, an investigational new drug application is filed with the FDA. In Phase I trials, new drugs are tested to assess toxicities and to determine the maximum tolerated dose. Phase II trials focus on determining the anti-tumor activity of the new drug against a specific type of cancer. Patients in this phase receive 75-90% of the maximum tolerated dose to prevent severe toxicity. In Phase III trials, the drug is compared with standardized therapies using randomized trials with large sample sizes. An institutional review board (IRB), affiliated with a university or health care organization, oversees the research process and has a major role in protecting patient rights and safety.

Since the mid-1990’s, about 80 new cancer related drugs, or new uses for drugs already on the market, have been approved. The FDA maintains an annotated online list of drugs approved for use. The list can be accessed at www.nci.nih.gov/clinical_trials. Some of these drugs treat cancer, and some alleviate pain and other symptoms. When considering a new drug, the FDA faces two challenges:

  1. Making sure that the drug is safe and effective before it is made available, and
  2. Ensuring that drugs which show promise are made available as quickly as possible to the people they can help.

This link has an internet brochure entitled: "Taking Part in Clinical Trials: What Cancer Patients Need to Know"

Click here for information about questions patients should ask their oncologist, before agreeing to participate in a clinical trial, and be prepared to answer a post-test question on the subject.


Nurses who care directly for patients may play several roles in clinical trials. Nurses may assist in recruiting patients into a clinical trial. They may ensure that informed consent is properly obtained, and may give research drugs as required by the specific protocol. Nurses also assess, manage, and document symptoms, potential toxicities, and the response of patients to the regimen. Nurses also play a role in coordinating all necessary tests, diagnostic procedures, and treatments to ensure that they are given in a safe, timely, and appropriate manner, assist with data collection, and provide patient and family education.