What are Phase I, Phase II, Phase III, and IV studies?
Phase 1 – The phase 1 study is used to learn the “maximum tolerated dose” of a drug that does not produce unacceptable side effects. Patient volunteers are followed primarily for side effects, and not for how the drug affects their disease. STAT Research does not currently conduct any Phase 1 trials.
Phase 2 – The phase 2 study involves a drug whose dose and side effects are well known. Many more volunteer subjects are tested, to define side effects, learn how it is used in the body, and learn how it helps the condition under study. Some volunteer subjects may benefit from a phase 2 study.
Phase 3 – The phase 3 study compares the new drug against a commonly used drug. Some volunteer subjects will be given the new drug and some the commonly used drug. The trial is designed to find where the new drug fits in managing a particular condition. Determining the true benefit of a drug in a clinical trial is difficult.
Phase 4 – A phase 4 study is often called a post-marketing study. This means the study drug is already FDA approved and marketed, but the sponsor is looking into additional aspects of the drug, such as use in other indications, dosages, routes, or to build a long-term safety profile.
The following section describes safeguards that protect the safety and rights of volunteer subjects. These safeguards include:
» The Independent Review Process
» Informed Consent Procedures
» Withdrawing Consent
Independent Review – All research conducted by STAT Research must be approved by an institutional review board (IRB) before they can begin. The IRB, which consists of medical specialists, statisticians, nurses, social workers, and medical ethicists, is the advocate of the volunteer subject. The IRB will only approve protocols that address medically important questions in a scientific and responsible manner.
Informed Consent – Your participation in any Clinical Center research protocol is voluntary. For every study in which you intend to participate, you will receive a document called “Consent to Participate in a Clinical Research Study” that explains the study in straightforward language. A member of the research team will discuss the protocol with you, explain its details, and answer your questions. Reading and understanding the protocol is your responsibility. You may discuss the protocol with family and friends. You will not be hurried into making a decision, and you will be asked to sign the document only after you understand the nature of the protocol and agree to the commitment.
Withdrawing Consent – At any time after signing the protocol, you are free to change your mind and decide not to participate further. This means that you are free to withdraw from the study completely or to refuse particular treatments or tests. Sometimes, however, this will make you ineligible to continue the study. If you are no longer eligible or no longer wish to continue the study, you will return to the care of the doctor or specialist.