Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals. Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies such as the National Institutes of Health, the U.
Department of Defense, and the U. Department of Veterans Affairs. Doctors, other health care providers, and other individuals can also sponsor clinical research. Clinical studies can take place in many locations, including hospitals, universities, doctors' offices, and community clinics.
The location depends on who is conducting the study. The length of a clinical study varies, depending on what is being studied. Participants are told how long the study will last before they enroll. In general, clinical studies are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions. Some common reasons for conducting clinical studies include:. 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:. 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.
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. The protocol is usually reviewed by an independent group of scientists and other professionals to help make sure that the study will be safe for the people with the disease or condition to participate in. Once the protocol is approved, the clinical trial can begin and participants can join.
During a clinical trial , the participants receive treatments and have tests done according to the protocol. Some trials compare a new treatment to a standard one that is already available. Other trials compare a treatment to a placebo. A placebo looks like a treatment but does not have any medicine in it. Some trials just look at a treatment without any comparisons. The research team collects information from the participants during the trial. Clinical trials also permit testing and monitoring of the effect of an intervention on a large number of people to ensure that any improvement as a result of the intervention occurs for many people and is not just a random effect for a one person.
Most modern medical interventions are a direct result of clinical research. New interventions for most diseases and conditions — including cancer, heart disease, high blood pressure and asthma — have been developed through clinical research.
Clinical trials often lead to new interventions becoming available that help people to live longer and to have less pain or disability. After you consent, you will be screened by clinical staff to see if you meet the criteria to participate in the trial or if anything would exclude you. The screening may involve cognitive and physical tests. Inclusion criteria for a trial might include age, stage of disease, sex, genetic profile, family history, and whether or not you have a study partner who can accompany you to future visits.
Exclusion criteria might include factors such as specific health conditions or medications that could interfere with the treatment being tested. Many volunteers must be screened to find enough people for a study. Generally, you can participate in only one trial or study at a time. Different trials have different criteria, so being excluded from one trial does not necessarily mean exclusion from another.
It is important for clinical trials to have participants of different ages, sexes, races, and ethnicities. When research involves a group of people who are similar, the findings may not apply to or benefit everyone. When clinical trials include diverse participants, the study results may have a much wider applicability. Researchers need the participation of older people in their clinical trials so that scientists can learn more about how the new drugs, therapies, medical devices, surgical procedures, or tests will work for older people.
Many older people have special health needs that are different from those of younger people. For example, as people age, their bodies may react differently to drugs. Older adults may need different dosages or amounts of a drug to have the right result.
Also, some drugs may have different side effects in older people than younger people. Having seniors enrolled in drug trials helps researchers get the information they need to develop the right treatment for older people. Researchers know that it may be hard for some older people to join a clinical trial.
For example, if you have many health problems, can you participate in a trial that is looking at only one condition?
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