Why Clinical Trials? (con’t)

Volunteers are essential to clinical trials. A patient volunteer - someone with a known health problem - can help researchers better understand, diagnose, treat, or cure that disease or condition. But healthy volunteers, who have no known major health problems, also play an important role in clinical research. They help researchers learn things that may indirectly help themselves and people they know. Both types of volunteers are needed, because researchers can learn more about a disease by comparing patient volunteers to healthy volunteers.

The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results.

Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ideas.

If an approach seems promising, the next step may involve animal testing. This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed.

For safety purposes, clinical trials start with small groups of patients to find out whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits.

Clinical trials are a key research tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know
• Whether a new approach works well in people and is safe and
• Which treatments or strategies work best for certain illnesses or groups of people.

Clinical trials help improve and advance medical care. They also can help health care decision maker’s direct needed sources to the strategies and treatments that work best.

Overview of Clinical Trial Process

• Each clinical trial has a master plan called a protocol. This plan explains how the trial will work. The trial is led by a principal investigator (PI), who often is a doctor. The protocol outlines what will be done during the clinical trial and why. Each medical center that does the study uses the same protocol.

• Clinical trials of new medicines or medical devices are done in phases. These phases have different purposes and help researchers answer different questions. For example, phase I clinical trials test new treatments in small groups of people for safety and side effects. Phase II clinical trials look at how well treatments work and further review these treatments for safety. Phase III clinical trials use larger groups of people to confirm how well treatments work, further examine side effects, and compare new treatments with other available treatments.

• A clinical trial's protocol describes what types of patients are able to take part in the research—that is, who is eligible. Each trial must include only people who fit the patient traits for that study (the eligibility criteria).

• Eligibility criteria differ from trial to trial. They include factors such as a patient's age and gender, the type and stage of disease, and whether the patient has had certain treatments or has other health problems. Eligibility criteria ensure that new approaches are tested on similar groups of people.

• Informed consent is the process of providing you with key information about a research study before you decide whether to accept to offer to take part. The process of informed consent continues throughout the study. To help you decide whether to take part, members of the research team explain the details of the study. The research team provides an informed consent document that includes details about the study, such as its purpose, how long it's expected to last, tests, or procedures that will be done as a part of the research, and who to contact for further information. The informed consent document also explains risks and potential benefits.

• If you decide to sign the informed consent document, you're still free to withdraw from the study at any time, even after it begins. Informed consent is not a contract; its purpose is to make sure that you know enough about the study to decide whether or not to participate.

• After a study is completed, clinical researchers carefully examine the information they've collected. The results are often published in scientific journals.