Types and Phases of Clinical Trials
Clinical trials help find better ways to prevent, diagnose, or treat a disease. There are several types of clinical trials, each with a different focus.
Prevention trials test new medicines, vitamins, or supplements that may lower the risk of developing certain cancers. These trials may include healthy people who have not had cancer or people who have had cancer and are trying to prevent it from coming back.
Screening trials study ways to find cancer earlier. They are often used to determine whether finding cancer before it causes symptoms decreases the chance of dying from the disease. These involve people have cancer but do not have any symptoms of cancer.
Family-based genetic studies use tissue or blood samples from families or large groups of people to find genetic changes linked to cancer. Participants may or may not have cancer, depending on the study. The goal is to understand how genes may be linked to cancer risk.
Quality-of-life studies explore ways to improve health and well-being of people with cancer during treatment and afterward. They also study how to best manage side effects and cancer and its treatments such as nausea, vomiting, depression, or other effects.
Diagnostic trials study tests or procedures that could find cancer more accurately. They usually include people who have signs or symptoms of cancer.
Interventional or treatment trials are a primary focus of HCI’s Clinical Trials Office. These focus on new treatments for adult cancer patients and have two main goals: ensure the safety of participants and ensure we are collecting all necessary data to evaluate the treatment.
Phases of Trials:
- Phase I trials are first-time tests of drugs or treatments on humans. Based on lab testing, researchers believe the drug or treatment will benefit people. The goal is to determine safety and dosage. All participants get the medicine.
- Phase II trials begin once an appropriate dosage of the drug is known from Phase I. In this stage, researchers determine the drug's effectiveness in treating a specific kind and stage of cancer.
- Phase III trials test drugs proven to be effective. They may compare the current standard therapy against the new therapy. Participants may be randomly assigned to treatment groups. Placebos may be used to compare effects.
- Phase IV trials further evaluate the long-term safety and effectiveness of a treatment. They usually take place after the treatment has been approved for standard use by the FDA.