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A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health.
There are different kinds of clinical trials, including those to study:
Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.
Many clinical trials are done to see if a new drug or device is safe and effective for people to use. Clinical trials are also done for other reasons. Some compare existing treatments to determine which is better. The current, approved treatments are called the "standard treatments." Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective, easier to use, and/or decrease side effects. Sometimes, studies are done to learn how to best use the treatment in a different population, such as children, in whom the treatment was not previously tested.
For most trials, researchers, doctors, and other health professionals administer the clinical trials according to strict rules set by the Food and Drug Administration (FDA). FDA sets the rules to make sure that people who agree to be in studies are treated as safely as possible.
People can find information about clinical trials now being conducted now by searching clinicaltrials.gov. ClinicalTrials.gov is an interactive online database, managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research in human volunteers. ClinicalTrials.gov is updated regularly and offers information on each trial's purpose, who is eligible to participate, locations, and phone numbers to call for more information.
Since ClinicalTrials.gov is only available online, individuals without Internet access can use the database at the public library or other publicly available internet portal.
There are many different kinds of clinical trials, including:
Usually, clincal trials compare a new product or therapy to something else
to see if it works as well or better to treat or prevent a disease or condition.
In a blinded study, a participant may be randomly assigned to receive the test
product, or an existing, approved therapy. In some studies, participants may
be assigned to receive a placebo (a product with no therapeutic action that
looks like the test product). Comparison with a placebo can be the fastest
and surest way to demonstrate therapeutic effectiveness of new products. However,
placebos are not used where a patient would be put at risk, particularly in
the study of treatments for serious illnesses, by not having effective therapy.
Most studies of this kind compare new products to an approved therapy. Potential
participants are told before they enter a trial whether placebos are going
to be used in the study.
It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments. FDA seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials.
Some people participate in clinical trials because they have exhausted standard (approved) treatment options - which either did not work for them, or they were unable to tolerate certain side effects. Clinical trials may provide another option when standard therapy has failed.
Other people participate in trials because the want to contribute to the advancement of medical knowledge.
For each clinical trial, researchers develop eligibility criteria, such as the age, sex, type and stage of disease, previous treatment history, and other medical conditions. These criteria help to reduce the amount of variation in the study, without threatening the scientific integrity of the trial, by removing medical variations that might complicate analyzing the results.
Not everyone who applies for a clinical trial will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers to collect enough information to determine the safety and effectiveness of a therapeutic agent.
Clinical trials can be sponsored by an organization such as a pharmaceutical company, a federal agency - for example, the National Institutes of Health or Veterans Administration -or an individual, such as a physician or health care provider. The sponsor determines the location(s) of the trials which are usually conducted at universities, medical centers, clinics, doctor's offices, and/or at hospitals, federally- and industry-funded research sites.
The FDA works to protect participants in clinical trials and to ensure that people have reliable information as they decide whether to join a clinical trial. The federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks.
Although efforts are made to control the risks to clinical trial participants, some risks may be unavoidable because of the uncertainty inherent in medical research studies involving new medical treatments.
The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Participants must sign an "informed consent" document before joining the study indicating they understand that the trial is research, and that they can leave the clinical trial at any time. This informed consent is part of a process that ensures a prospective participant in a clinical trial understands what known risks might be associated with the study, and whether there are potential, but as yet unknown risks that may be associated with the product being studied. This information permits someone deciding whether or not to enter a clinical trial to make an informed decision about the level of risk they are willing to accept before they enter the trial.
People should learn as much as possible about the clinical trials that interest them. They should also feel comfortable discussing their questions and concerns with members of the health care team. Prospective participants should understand what happens during the trial, the type of health care they will receive, and any costs to them - which may or may not include the cost of the product, costs associated with administering the product, etc.
Anyone considering a clinical trial should also know that there are benefits and risks associated with participating.
Participating in well-designed and well-executed clinical trials is one approach for eligible patients/volunteers to:
There are generally known and unknown risks associated with clinical trials, such as:
Payment/compensation:
Potential Conflict of Interest:
Continued Treatment:
The Food and Drug Administration's job is to make sure medical treatments are safe and effective for people to use. However, FDA does not develop new therapies, or conduct the clinical trials to demonstrate safety and effectiveness. FDA staff members meet with researchers, and perform inspections of clinical trial study sites to protect the rights of participants and to verify the quality and integrity of the data.
For more about FDA's role in clinical trials, please see the FDA Consumer article, Inside Clinical Trials Testing Medical Products in People.