These clinical trials may also show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce high-quality data for healthcare decision making. The purpose of clinical trials is to answer scientific questions. Therefore, these studies follow strict, scientific standards which protect patients and help produce reliable clinical trial results. Clinical trials are one of the final stages of a long and careful research and development process.
The process often begins in a laboratory, where scientists first develop and test new ideas. We do not develop new therapies or conduct clinical trials. Rather, we oversee the people who do. FDA staff meet with researchers and perform inspections of clinical trial study sites to protect the rights of patients and to verify the quality and integrity of the data. Learn more about the Drug Development Process. One good way to find out if there are any clinical trials that might help you is to ask your doctor.
Other sources of information include:. A placebo is a pill, liquid, or powder that has no treatment value. It is often called a sugar pill.
In clinical trials that include placebos, quite often neither patients nor their doctors know who is receiving the placebo and how is being treated with the experimental drug. Many cancer clinical trials, as well as trials for other serious and life-threatening conditions, do not include placebo control groups.
In these cases, all participants receive the experimental drug. Ask the trial coordinator whether there is a chance you may get a placebo rather than the experimental drug. 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.
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. 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. 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 FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.
Typically, participants continue to see their usual health care providers while enrolled in a clinical study. Depending on the stage of knowledge about the disease or condition, these procedures may or may not benefit the patient volunteer. In the past, clinical trial volunteers often were white men. Researchers assumed that study results were valid for other populations as well. Today, researchers realize that women and people from different racial and ethnic groups sometimes respond differently than white men to the same medical approach.
As a result, the NIH and the NHLBI are committed to supporting clinical trials that include both men and women as well as racially and ethnically diverse populations. Children need clinical trials that focus on them, as medical treatments and approaches often differ for children. For example, children may need lower doses of certain medicines or smaller medical devices. A clinical trial's protocol describes who is eligible to take part in the research.
Each study must include only people who meet the requirements for that study. These are the study's eligibility criteria. Eligibility criteria are different for each trial. They include whether you are a healthy or patient volunteer. They also include factors such as your age and sex, the type and stage of disease, and whether you have had certain treatments or have other health problems.
The criteria ensure that new approaches are tested on similar groups of people. This makes it clear to whom a clinical trial's results apply. Eligibility criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe, and to help ensure that researchers can find the new information they need.
Clinical trials offer hope for many people, while giving researchers a chance to find treatments that could benefit patients in the future. Healthy volunteers say they take part to help others and contribute to moving science forward. People with an illness or disease may take part to help others, but also to have a chance to receive the newest treatment and get added care and attention from the clinical trial staff.
Clinical trials may involve risk, as can routine medical care and the activities of daily living. When weighing the risks of clinical trials, consider the possible harms that could result from taking part in the study, the level of harm, and the chance of any harm occurring. In clinical trials that compare a new product or therapy with another that already exists, researchers try to determine if the new one is as good, or better than, the existing one.
In some studies, you may receive a placebo. Comparing a new product with a placebo can be the fastest and most reliable way to show the new product's effectiveness. However, placebos are not used if you would be put at risk—particularly in the study of treatments for serious illnesses—by not having effective therapy. You will be told if placebos are used in the study before entering a trial.
You can learn about the risks and benefits of any clinical trial and how your rights are protected before you agree to take part in the trial. A member of the research team will explain the study and answer any questions about the study. A member of the research team will also ask you to consider and sign an informed consent document, which will describe in detail the specific risks associated with a research protocol.
Before deciding to participate, carefully consider risks and possible benefits. You can also talk with your doctor about specific clinical trials you are interested in. If you are thinking about taking part in a clinical trial, you should feel free to ask any questions or bring up any issues concerning the trial at any time.
The following suggestions may give you some ideas as you think about your own questions. Protecting the safety of people who take part in clinical trials is a high priority for the NHLBI and its researchers. You also have rights to help protect your safety. As a participant in a clinical trial, you have rights that help protect your safety. These rights include:. The NHLBI has a strong tradition of supporting clinical trials that have shaped medical practice around the world.
These trials have improved the health of millions of people suffering from heart, lung, and blood disorders. Based on input from a broad group of stakeholders and advisory groups, the NHLBI established a multi-pronged approach to making our clinical trials enterprise even stronger. This effort is called Optimize our Clinical Trials Enterprise. The NHLBI's funding announcements will help lead investigators to more interpretable, timely, and useful results, which in turn will improve public health.
We offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including pilot studies. View funding information for clinical trials optimization. The NHLBI leads or supports many studies aimed at preventing, diagnosing, and treating heart, lung, blood, and sleep disorders. Learn more about participating in a clinical trial. View all trials from ClinicalTrials. Visit Children and Clinical Studies to hear experts, parents, and children talk about their experiences with clinical research.
After reading our Clinical Trials Health Topic, you may be interested in additional information found in the following resources. Clinical Trials Also known as clinical research. Clinical trials are medical studies that involve people like you. They help find new ways to prevent, detect, or treat diseases that are safe and effective. Clinical trials are an important part of the research spectrum.
The idea for a clinical trial often starts in the lab. After researchers test new treatments or procedures in the lab and in animals, the most promising treatments are moved into clinical trials. As studies about new treatments move through a series of steps called phases, researchers learn more information about the treatment, its risks, and its effectiveness. Each clinical trial has criteria describing who can join. Children as well as adults, healthy volunteers and patients, and people of a diverse range of ethnic and racial backgrounds can and are encouraged to participate in clinical trials.
0コメント