Introduction to Clinical Trials

Other Websites

ClinicalTrials.gov
The website for research sponsored by the National Institute of Health

National Coalition for Cancer Survivorship
Excellent overview of the types of clinical trials, patient protections and tips for finding relevant clinical trials.

National Cancer Institute's Introduction to Clinical Trials
Provides a comprehensive page on cancer clinical trials, including a publication on participating in clinical trials for cancer prevention.

Research is the best way for the medical community to discover better methods to detect, prevent, or treat cancer, or to improve quality of life. These discoveries are made through careful study of different medical options to determine benefits, limitations, and risks compared with current standard care. Participating in research allows people to contribute to medical knowledge and offers the opportunity to receive cutting-edge care.

Participating in Research

Participation in research sometimes carries risk; some studies carry very small risks while other studies - particularly those involving new medications - maycarry significant risks.

In order to conduct research in the United States and most other countries, researchers must follow stringent guidelines to assure all participants are aware of the risks and their rights prior to participating in research.

The guidelines require researchers to provide people interested in participating an "informed consent form," which explains the following to potential participants:

• the purpose of the research
• potential risks of the research
• criteria for participating in the research
• alternatives to participating in research
• contact information for reporting an adverse effect during the research
• the voluntary nature of the study and that participants can leave a research study at any time they choose

Clinical Trials

Researchers conduct clinical trials to test a new drug for treatment, relief of symptoms, or for prevention of disease. The process involves a systematic series of steps to assure the drug is safe and effective. These steps usually involve three “phases” of testing:

• Phase I trials usually involve a small number of patients and are designed to evaluate safety and optimal dosing of a new drug.
• Phase II trials further test a new drug’s safety and efficacy.
• Phase III trials involve a larger number of participants and compare new drugs to current standard treatments. Participants are usually randomly assigned to the group receiving standard treatment or the group receiving the new treatment. Phase III cancer treatment trials do not include a placebo arm (unless there is no standard treatment for that particular cancer). Placebo arms may be included in chemoprevention trials studying drugs that might lower cancer risk in people who do not already have the disease.

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