Learn About Clinical Studies - Clinical. Trials. gov. Contents. What Is a Clinical Study? A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. Some clinical trials compare interventions that are already available to each other. Learn about CRISP and how to navigate CRISP's Clinical Query Portal successfully. These. phases are defined by the Food and Drug Administration (FDA). Some people who are not eligible to participate in a clinical trial may be able to get. Expanded Access Program. See. more information on expanded access from the National Library of Medicine. Observational Studies. In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Department of Defense, and the U. S. Department of Veterans Affairs. ![]() These can include medicines, vaccines, or lifestyle changes, among other approaches. Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or condition. Examining methods for identifying a condition or the risk factors for that condition Exploring and measuring ways to improve the comfort and quality of life through supportive care for people with a chronic illness. Participating in Clinical Studies.
A clinical study is conducted according to a research plan known as the protocol. The protocol is designed to answer specific research questions and safeguard the health of participants. It contains the following information: The reason for conducting the study. Who may participate in the study (the eligibility criteria)The number of participants needed The schedule of tests, procedures, or drugs and their dosages. The length of the study What information will be gathered about the participants. Who Can Participate in a Clinical Study? Clinical studies have standards outlining who can participate. These standards are called eligibility criteria and are listed in the protocol. Some research studies seek participants who have the illnesses or conditions that will be studied, other studies are looking for healthy participants, and some studies are limited to a predetermined group of people who are asked by researchers to enroll. Eligibility. 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. How Are Participants Protected? Informed consent is a process used by researchers to provide potential and enrolled 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 of, potential benefits of, 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. See the Questions to Ask section on this page for questions to ask a health care provider or researcher about participating in a clinical study. Institutional review boards. Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA 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. Its role 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, among other responsibilities. There have been a number of human clinical trials using an alternative gene-editing technique, including one led by June, that have helped patients combat HIV. Crisp trial to start Monday Local News. ROCKWELL CITY – The trial of a Pomeroy man accused of killing a North Dakota man in November is set to begin. The IRB also reviews the informed consent document. In addition to being monitored by an IRB, some clinical studies are also monitored by. Various Federal agencies, including the Office of Human Subjects Research Protection and FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants. Relationship to Usual Health Care. Typically, participants continue to see their usual health care providers while enrolled in a clinical study. While most clinical studies provide participants with medical products or interventions related to the illness or condition being studied, they do not provide extended or complete health care. By having his or her usual health care provider work with the research team, a participant can make sure that the study protocol will not conflict with other medications or treatments that he or she receives. 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 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. Some trials may provide participants with the prospect of receiving direct medical benefits, while others do not. 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. 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. Questions to Ask. Anyone interested in participating in a clinical study should 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 some of these questions are provided in the. 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 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? This page last reviewed in December 2.
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