Clinical Trials Glossary
Best Available Standard Treatment
Also known as the control treatment, the best available standard treatment is the current treatment that has shown the best results in past trials. The standard is evolving as clinical trials identify new treatments with better results. If a patient is in a Phase 3 clinical trial (below), he will get either an "experimental" treatment or the best available standard treatment (control treatment).
Phases for Cancer Trials
A trial's phase defines the type of testing occurring at a specific point. Clinical trials for anti-cancer drugs are conducted in three phases:
- Phase 1 trials test dosage levels and the best way to apply the treatment (pills or injections; daily, hourly, weekly or continuously); side effects are monitored and used to determine the appropriate dosage levels for Phase 2 testing
- Phase 2 trials examine the effectiveness against selected types of cancers
- Phase 3 trials systematically compare the outcomes — the effectiveness and side effects — of the best available standard treatment and the experimental treatment(s)
The phase of the trial is not necessarily related to the stage of the cancer being studied. There are Phase 1 trials for all stages of cancer.
A protocol is a blueprint for the trial, which describes how the trial will proceed, what types of patients will be eligible for the trial, the number of patients required, the type of care they will receive and so on. All protocols are reviewed by the sponsoring group (for example, the NCI or FDA) and the IRB (Institutional Review Board) of the institution where the research is being conducted to ensure patients are fully informed and that risks are minimized.
Clinical trials can include multiple "arms." Each arm is a study group of patients receiving a specific treatment or combination of treatments that is being compared to other treatment arms as well as to the control arm. The "control arm" is the best available standard treatment.
Institutional Review Board (IRB)
Each research institution has an Institutional Review Board. The IRB, which includes non-medical and medical people, reviews all protocols for patient safety. The board also reviews the consent information given to patients who are thinking about participating in the trial, to make sure that it is written in clear, understandable language.
The principle of informed consent means that patients have the right to be fully informed about a trial before agreeing to participate in that trial. The patient receives complete trial information, including treatment specifics, potential risks, benefits and side effects. The patient must sign an "informed consent form" before he or she is allowed to participate. If the protocol changes during the trial, the informed consent process is repeated.
National Cancer Institute (NCI)
NCI is a federal agency that oversees the nation's cancer research program. Many clinical trials are funded by and/or conducted with NCI. There are also NCI Cancer Centers around the country; these are clinical and research facilities that meet NCI criteria and standards for cancer research.
Food and Drug Administration (FDA)
The FDA's role is to oversee the pharmaceutical research conducted by drug companies, university research centers and physicians to make sure that federal regulations governing this research are followed.
Drug approval process
The US Food and Drug Administration (FDA) oversees the testing and subsequent approval of any new pharmaceutical candidate. While the process can last several years, it is necessary to ensure the safety of the people who may eventually receive treatment.
- From Test Tube to Patient
New explanation of drug development process from the FDA
- FDA Drug Approval Process
NCI's explantion of the FDA approval process