If you are interested in any of our clinical trials please contact our staff - see the our Team section. Participation in these trials is entirely voluntary, and you will be made well aware of risks, benefits, and side effects. A list of current trials is in the Browse Studies section of this site. Some general information about clinical trials is outlined below.
A clinical study involves research using human volunteers (also called participants) that is intended
to add to medical knowledge. There are two main types of clinical studies: clinical trials and
observational studies. ClinicalTrials.gov includes both interventional and observational studies.
In a clinical trial (also called an interventional study), participants receive specific interventions
according to the research plan or protocol created by the investigators. These interventions may be
medical products, such as drugs or devices; procedures; or changes to participants' behavior, for
example, diet. Clinical trials may compare a new medical approach to a standard one that is already
available or to a placebo that contains no active ingredients or to no intervention. Some clinical trials
compare interventions that are already available to each other. When a new product or approach is
being studied, it is not usually known whether it will be helpful, harmful, or no different than available
alternatives (including no intervention). The investigators try to determine the safety and efficacy of
the intervention by measuring certain outcomes in the participants. For example, investigators may
give a drug or treatment to participants who have high blood pressure to see whether their blood
Clinical trials used in drug development are sometimes described by phase. These phases are
defined by the Food and Drug Administration (FDA).
Note: Some people who are not eligible to participate in a clinical trial may be able to get
experimental drugs or devices outside of a clinical trial through an Expanded Access Program. See
more information on expanded access from the National Library of Medicine.
In an observational study, investigators assess health outcomes in groups of participants according
to a protocol or research plan. Participants may receive interventions, which can include medical
products, such as drugs or devices, or procedures as part of their routine medical care, but
participants are not assigned to specific interventions by the investigator (as in a clinical trial).
For example, investigators may observe a group of older adults to learn more about the effects of
different lifestyles on cardiac health.
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
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, U.S. Department of Defense, and U.S. Department of Veterans Affairs.
Physicians, 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 enrolling.
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
Evaluating one or more interventions (for example, drugs,
medical devices, approaches to surgery or radiation
therapy) for treating a disease, syndrome, or condition
Finding ways to prevent the initial development or recurrence
of a disease or condition. 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 risk factors
for that condition
Exploring and measuring ways to improve the comfort
and quality of life of people with a chronic illness through
A clinical study is conducted according to a research plan known as the protocol. The protocol is
designed to answer specific research questions as well as 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 theirdosages
- The length of the study
- What information will be gathered about the participants
Clinical studies have standards outlining who can participate, called eligibility criteria, which 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.
These are based on things such as age, gender, the type and stage of a disease, previous treatment
history, and other medical conditions.
Informed consent is a process in which researchers 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 entering a study to show that he or she was given information on risks, potential benefits,
and alternatives and 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 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 physicians, researchers,
and members of the community. Its role is to make sure that the study is ethical and 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 things. 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 (OHRP) 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. 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 the participant's usual health care provider work with the research team, the participant
can make sure that the study protocol will not conflict with other medications or treatments being
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 more than the risks related to routine medical
care or disease progression. (For trials approved by IRBs, 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 will be described in the informed consent document for a particular trial. A potential
participant should also discuss these issues with members of the research team and with his or her
usual health care provider.
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 might be helpful during such a discussion.
Answers to some of these questions are provided in the informed consent document. Many of these
questions are specific to clinical trials, but some also apply to observational studies.
- 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
- 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 in the trial?
- What are my options if I am injured during the study?