Phase II clinical trials designed cancer
- The term “phase” is used to describe the goals of a clinical trial.
- Phase I clinical trials are used to show that a new treatment is safe for a small group of people and to find the best dose and schedule for future research of the drug or drug combination.
- Phase II clinical trials provide more information about the safety of the new treatment and how well it works to treat a specific type of cancer.
- Phase III clinical trials compare a new treatment or treatments with the standard treatment in a large group of people.
Clinical trials are done in phases. Each phase describes the general information about a new treatment that is being collected in a clinical trial, such as the dose, safety, and how well it works. The phases are called I, II, and III.
Before a new treatment can be given to patients, the underlying research hypothesis (the explanation for how the new treatment works) must be proven in a laboratory. This stage is called preclinical research, and it often takes years to turn this knowledge into a new treatment.
If the laboratory research suggests that the treatment might be an effective cancer treatment, the sponsor of the clinical trial files an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) asking permission to study the treatment in people. If the IND application is approved, researchers can move on to the next step of research, which includes studies to find out more about the treatment.
Phase I clinical trials
The goal of a phase I clinical trial is to show that a new drug or treatment, which has proven to be safe for use in animals, may also be given safely to people. Doctors collect data on the dose, timing, and safety of the treatment. People who participate in phase I clinical trials are often the first to receive a new therapy or a new combination of therapies.
Clustering in Bioinformatics and Drug Discovery (Chapman & Hall/CRC Mathematical & Computational Biology)
Book (CRC Press)
BMC Medical Research Methodology at the 35th Annual Conference of the .. — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.