NICRC F.A.Q.

	Why should I participate in a clinical trial?
	People join a trial or research study for many different reasons. By being in a study, subjects (participants in a trial) can help to advance medical knowledge, have early access to promising drugs that are otherwise not available, play an active role in their health care, and frequently have free medical care, tests, and medications during the trial.
	What types of clinical trials are available?
	There are two basic types of clinical trials available. Treatment trials are studies conducted with cancer patients to evaluate standard of care in comparison to new treatments previously proven to be effective in the laboratory. These trials are directed towards patients with specific types of cancer, stage of disease and health status. Chemoprevention trials are studies that suggest ways to prevent or control cancer. Prevention trials are designed to answer a set of research questions. Persons with certain commonalities such as similar lifestyles, heredity, and risk factors can enroll in chemoprevention trials.
	How are clinical trials conducted?
	Clinical trials are usually conducted in a series of steps, called phases. Each phase is defined to find out different information. Phase 1: Determines the maximum tolerated dose and identifies side effects. Phase II: Determines whether the treatment is effective. Phase III: Compares the new treatment with other treatments already in use. Phase IV: Ongoing evaluation after the treatment has been approved and is available for public use. Adjuvant Trials: Determines if additional therapy will improve the chance for cure in patients at risk for recurrence after surgical removal of all visible disease.
	Why are clinical trials important?
	All clinical trials answer specific questions pertaining to a variety of disease. The answer researchers obtain from these studies result in knowledge about the effectiveness of new treatments and help determine risks and side effects from those treatments. Every cancer patient will receive, at minimum, standard of care therapy that can be compared to new treatment options. The comparative studies determine if one treatment is more effective than the other, either because of short-term response, long-term-response, or in fewer side effects.
	How are participants protected?
	Research with people is conducted according to strict scientific and ethical principles. Every clinical trial has a protocol, or action plan, which acts like a "recipe" for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. The same protocol is used by every doctor or research center taking part in the trial. All federally funded clinical trials and trials to evaluate a new drug or medical device subject to Food and Drug Administration regulation must be reviewed and approved by an Institutional Review Board (IRB). The Board, which includes doctors, researchers, community leaders, and other members of the community, reviews the protocol to make sure the study is conducted fairly and participants are not likely to be harmed. An IRB can stop a clinical trial if the researcher is not following the protocol or if the trial appears to be causing unexpected harm to the participants. An IRB can also stop a clinical trial if there is clear evidence that the new intervention is effective, in order to make it widely available.
	What are eligibility criteria, and why are they important?
	Each study's protocol has guidelines for who can or cannot participate in the study. These guidelines, called eligibility criteria, describe characteristics that must be shared by all participants. The criteria differ from study to study. These guidelines, called eligibility criteria, describe characteristics that must be shared by all participants. The criteria differ from study to study. They may include age, gender, medical history, and current health status. Eligibility criteria for treatment studies often require that patients have a particular type and stage of cancer. Enrolling participants with similar characteristics ensures that the results will be due to what is under study and not other factors. In this way, eligibility criteria help researchers achieve accurate and meaningful results. These criteria also make certain that people who could be made worse by participating in the study are not exposed to the risk.
	What is informed consent?
	Informed consent is a process by which people learn the important facts about a clinical trial to help them decide whether to participate. This information includes details about what is involved, such as the purpose of the study, the tests and other procedures used in the study, and the possible risks and benefits. In addition to talking with the doctor or nurse, people receive a written consent form explaining the study. People who agree to take part in the study are asked to sign the informed consent form. However, signing the form does not mean people must stay in the study. People can leave the study at any time-either before the study starts or at any time during the study or the follow-up period. The informed consent process continues throughout the study. If new benefits, risks, or side effects are discovered during the study, the researchers must inform the participants. They may be asked to sign new consent forms if they want to stay in the study.
	What happens when a clinical trial is over?
	After a clinical trial is completed, the researchers look carefully at the data collected during the trial before making decisions about the meaning of the findings and further testing. After a phase I or II trial, the researchers decide whether to move on to the next phase, or stop testing the agent or intervention because it was not safe or effective. When a phase III trial is completed, the researchers look at the data and decide whether the results have medical importance. The results of clinical trials are often published in peer-reviewed, scientific journals. Peer review is a process by which experts review the report before it is published to make sure the analysis and conclusions are sound. If the results are particularly important, they may be featured by the media and discussed at scientific meetings and by patient advocacy groups before they are published. Once a new approach has been proven safe and effective in a clinical trial, it may become standard practice. (Standard practice is a currently accepted and widely used approach.)
	What are some of the benefits of taking part in a clinical trial?
	The benefits of participating in a clinical trial include the following: Participants have access to promising new approaches that are often not available outside the clinical trial setting. The approach being studied may be more effective than the standard approach. Participants receive regular and careful medical attention from a research team that includes doctors and other health professionals. Participants may be the first to benefit from the new method under study. Results from the study may help others in the future.