How are clinical trials carried out?


Research with people is carried out according to strict scientific and ethical principles. These include:

  • Each clinical trial has a protocol (action plan) that explains how the study will be carried out.
  • The person in charge of the study is called the investigator. This is usually a doctor. The investigator prepares the protocol for the study. This protocol explains what will be done and why. It outlines:
    • how many people will take part in the study
    • what medical tests they will receive and how often
    • the treatment plan

The same protocol is used by each doctor that takes part in the study.

  • For patient safety, each protocol is approved by:
    • The organization that sponsors the study (such as the National Cancer Institute or American Cancer Society).
    • Penn's Institutional Review Board, (IRB). This board, which includes consumers, clergy, and health professionals, reviews the protocol to ensure that the research will not expose patients to extreme or unethical risks.
    • The Cancer Center's Clinical Trials and Scientific Review and Monitoring Committee, which is approved by the National Cancer Institute and reviews the scientific merit of a clinical trial before it begins.
  • Each study enrolls people who are alike in key ways. Each study's protocol describes the characteristics that all patients in the study must have. These key characteristics are called eligibility criteria. Eligibility criteria differ from study to study, depending on the research purpose. They may include such factors as age, gender, the type and stage of cancer.
  • Cancer clinical trials are carried out in three different phases. Each phase answers different questions about the new treatment.
    • Phase I trials are the first step in testing a new treatment in humans. In these studies, researchers look for the best way to give a new treatment. Such as, by mouth, IV drip, or injection and how frequently it should be given. They also try to find out if and how the treatment can be given safely (e.g., best dose). They also watch for any harmful side effects. Because less is known about the possible risks and benefits in Phase I, these studies usually include only a small number of patients who would not be helped by other known treatments.
    • Phase II trials focus on learning whether the new treatment has an anticancer effect. Such as: does it shrink a tumor or improve blood test results? As in Phase I, only a small number of people take part because of the risks and unknowns involved.
    • Phase III trials compare the results of people taking the new treatment with results of people taking standard treatment. In most cases, studies move into Phase III testing only after a treatment shows promise in Phases I and II. Phase III trials may include hundreds of people around the country.

Talk to your Doctor or Nurse about a Clinical Trial that might be right for you.