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A clinical study (also called clinical research or clinical trial) involves research using human volunteers (also called participants) that is intended to advance medical knowledge. The main type of clinical study is often called a “clinical trial” or “interventional study”.

Clinical Trials

In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. Some examples of interventions include drugs, devices, procedures, and changes to diet, among others. Clinical trials often contain a treatment comparison such as the standard medical approach (e.g., an already approved drug) or the new intervention may be compared to placebo. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health.

Not all studies at �°������ϲʿ����� involve drugs or interventions; some studies use surveys or evaluate medical records to find new and better ways to help people. Other studies recruit healthy subjects, or controls, to better evaluate and compare their results with those of non-healthy subjects.

A protocol is the study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

Clinical studies have standards outlining who can participate. These standards are called eligibility criteria and are listed in the protocol (the research plan). Some research studies seek participants who have the illnesses or conditions that will be studied, while other studies are looking for healthy participants.

The factors that allow someone to participate in a clinical study are called inclusion criteria, and the factors that disqualify someone from participating are called exclusion criteria. They are based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

Informed consent is a process used by researchers to provide potential participants with information about a clinical study. This information helps people decide whether they want to enroll or continue to participate in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks, potential benefits, and alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding. In general, a person must sign an informed consent document before joining a study to show that he or she was given information on the risks, potential benefits, and alternatives and that he or she understands it. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.

Institutional review boards

Each clinical study conducted at �°������ϲʿ����� must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community. The role of the IRB is to make sure that the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits. The IRB also reviews the informed consent document.

In addition to being monitored by an IRB, some clinical studies are also monitored by data monitoring committees (also called data safety and monitoring boards).

Various Federal agencies, including the Office of Human Subjects Research Protection and the FDA have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.

Participating in a clinical study contributes to medical knowledge. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions.

Clinical trials allow eligible participants to:

• Play an active role in their health care
• Gain access to new research treatments before they are widely available
• Obtain expert medical care at leading health care facilities during the trial
• Help others by contributing to medical research

As a participant, you may be eligible for compensation for your time and travel involved with the clinical trial.

Some trials may provide participants with the prospect of receiving direct medical benefits, while others do not.

Clinical trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. Sometimes, the safety and the effectiveness of the experimental approach or use may not be fully known at the time of the trial. There may be unpleasant, serious or even life-threatening side effects to the experimental treatment or the experimental treatment may not be effective for the participant.

Most trials involve some risk of harm or injury to the participant, although it may not be greater than the risks related to routine medical care or disease progression. For trials being done at �°������ϲʿ�����, the IRB has decided that the risks of participation have been minimized and are reasonable in relation to anticipated benefits.

Many trials require participants to undergo additional procedures, tests, and assessments based on the study protocol. These requirements will be described in the informed consent document. A potential participant should also discuss these issues with members of the research team and with his or her usual health care provider.

At �°������ϲʿ����� we want you to know as much as possible about the study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses. The following questions may be helpful during such a discussion. Answers to many of these questions are provided in the informed consent document.

• What is being studied?
• Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before?
• What are the possible interventions that I might receive during the trial?
• How will it be determined which interventions I receive (for example, by chance)?
• Who will know which intervention I receive during the trial? Will I know? Will members of the research team know?
• How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
• What will I have to do?
• What tests and procedures are involved?
• How often will I have to visit the hospital or clinic?
• Will hospitalization be required?
• How long will the study last?
• Who will pay for my participation?
• Will I be reimbursed for other expenses?
• What type of long-term follow-up care is part of this trial?
• If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
• Will results of the study be provided to me?
• Who will oversee my medical care while I am participating in the trial?
• What are my options if I am injured during the study?

Yes, most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

Yes, a participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

Clinical trials are sponsored or funded by a variety of organizations or individuals such as Universities, foundations, voluntary groups, and pharmaceutical companies. In addition federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA) may sponsor studies. Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.

A control is the comparison by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment. Frequently clinical trials that involve a placebo control will allow all participants to transition to the experimental treatment after the initial portion of the study is complete.

Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.

Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening trials test the best way to detect certain diseases or health conditions.

Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and