Study designed to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research or research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work. Once researchers test new therapies or procedures in the laboratory and get promising results, they begin planning clinical trials. New therapies are tested on people only after laboratory and animal studies show promising results.

A biomedical or behavioral research study of human subjects that involve drug, device, or therapeutic intervention(s) in patients. May proceed through four phases: Phase I. Testing in a small group of people (e.g. 20-80) to determine efficacy and evaluate safety. Phase II. Study in a larger group of people (several hundred) to determine efficacy and further evaluate safety. Phase III. Study to determine efficacy in large groups of people (several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use. Phase IV. Studies done after the intervention has been marketed. Designed to monitor effectiveness of the approved intervention in the general population and collect information about any adverse effects associated with widespread use.

Study of the effectiveness of a drug or treatment

a prospective, scientific evaluation of a treatment regimen, agent (e.g., a drug), device, or procedure used for the prevention, diagnosis, or treatment of a disease.

A research study designed to answer specific questions about a particular disease.

study of one or more drugs in people.

a scientifically controlled study of a new drug's effectiveness. The typical clinical trial compares the medical impact of a new drug - when given to a group of patients with the same disease - to the clinical experience of a similar group of patients given a placebo or "dummy" version of the same drug, or an older, established drug, or no drug at all. Many health plans will not pay for patients enrolled in clinical trials.

An experiment on patients to determine the efficacy of a preventive or therapeutic agent or procedure.

A research study conducted with humans to study a new ways for treating, diagnosing, and preventing disease.

A scientific study to determine the effects of potential medicines in people; usually conducted in three phases (I, II, III), to determine whether the drug is safe, effective, and better than current therapies, respectively.

A study to find out whether a new type of care is better than the best standard care currently available. See clinical trials section.

A clinical trial is a research study that evaluates new and better ways to prevent disease and to improve treatment outcomes for people with diseases like cancer.

A carefully planned study of a new drug or treatment approach or a new application of an existing drug or approach. In a Phase I trial, a new agent that has been tested on cells and than animals in the laboratory is examined in a relatively small number of volunteers, often with advanced disease and poorly responsive or unresponsive to existing treatment, to assess dosages, patient tolerance, and acute toxic effects. If efficacy is evident, the new approach may be tested in a Phase II trial in which more patients are studied and more information gathered on dosage, effects, and toxicity. In a phase III trial, the drug or drugs or new approaches are compared in patients who are randomized to receive the current existing best treatment or the new treatment. Larger numbers of patients are studied. An effort is made to minimize observer bias. Carefully analysis of results is performed. Such trials are required to gain the information required by the Food and Drug Administration to determine efficacy and safety before approving a drug for marketing. Federal guidelines for informed consent of participants must be followed.

a carefully planned process by which researchers evaluate experimental new therapies and drugs through an orderly series of phases. Phase I trials evaluate how a new therapy or drug should be given, how often, and what dose is safe. Phase II trials continue to test safety but also begin to evaluate how well it works. Phase III trials test a new therapy or drug in comparison to the current standard of care. Participants are randomly assigned to the standard or new therapy. A placebo is only used when there is no standard therapy for comparison. Placebos are not used in Phase I or II. Phase IV trials are required when a drug manufacturer wishes to test an approved therapy for a different condition or with a different formulation. See Clinical Trials in Resource Section.

A research study involving participants, usually to find out how well a new drug or treatment works in people and how safe it is.

A scientifically designed and executed investigation of the effects of a drug (or vaccine) administered to human subjects. The goal is to define the safety, clinical efficacy, and pharmacological effects (including toxicity, side effects, incompatibilities, or interactions) of the drug. The U.S. government, through the FDA, requires strict testing of all new drugs and vaccines prior to their approval for use as therapeutic agents. See entries for Phase I, II, III, and IV Trials.

An organized research study conducted with people or animals to find new methods to prevent, detect, diagnose, or treat a disease. Clinical trials often compare a new treatment to a standard one.

a study to evaluate the effectiveness of newly designed treatments.

The evaluation in humans of the effectiveness of a new drug therapy. The phases of a clinical trial are: Phase I, the evaluation of the safety of the drug; Phase II, the determination of optimal dosage and effectiveness; and Phase III, the large-scale ev

A prospectively planned scientific study of the effects of a diagnostic test or treatment on selected patients, usually with respect to safety, efficacy, and/or quality of life.

A controlled study involving human participants, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions.

A method in medical research used to determine if new drugs and treatments are safe and effective. They usually involve experiments with either animals or organisms.

an investigation to evaluate how well a treatment (often a drug or combination of drugs) works in humans

A research design used to test the effects of a treatment such as a therapy approach or medication. Researchers compare treatment group results with control group results. Also see control group.

A research study involving human subjects, designed to evaluate the safety and effectiveness of new therapeutic and diagnostic treatments.

a clinical trial is a research study that involves human volunteers with specific health conditions. The trials allow the examination of a proposed drug or therapy in a controlled environment to determine its safety and effectiveness in treating patients with certain conditions.

Medical research conducted with volunteers. Each trial is designed to answer scientific questions and to find better ways to prevent or treat disease.

An experimental study to test the efficacy and potential side effects of an intervention such as a drug, vaccine, or medical device.

Research conducted with volunteer patients, usually to evaluate a new treatment, under strictly controlled conditions. Each trial is designed to answer scientific questions and to find better ways to treat individuals with a specific disease.

A carefully designed and executed investigation of a drug, drug dosage, combination of drugs, or other method of treating disease. Each trial is designed to answer one or more scientific questions and to find better ways to prevent or treat disease.

A scientific study in which physician-researchers study the effects of potential medicines on people; usually conducted in three phases (I, II, and III) that determine safety, whether the treatment works, and if it's better than current therapies, respectively.

Carefully monitored and planned testing of a new drug or treatment.

Direct observation of a patient to answer specific questions about therapies or new methods (see clinical trials section of the site)

Tests of a treatment's effects in humans. Clinical trials help researchers find out whether a promising treatment is safe and effective for people. They also tell scientists which treatments are more effective than others.

An investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational drug, and/or to identify any adverse events to any investigational drug, and/or to study absorption, distribution, metabolism, and excretion of an investigational drug with the object of ascertaining its safety and/or efficacy.  The terms clinical trial and clinical study are synonymous.

The scientific evaluation of the means to prevent, detect, diagnosis, or treat disease in human beings. Clinical trials are conducted after experiments in animals have shown evidence of potential effectiveness and preliminary studies in humans suggest usefulness.

An organized way to learn about health and the prevention, diagnosis and treatment of diseases and other medical conditions; often used to refer to studies involving medicine ("drug trials") or devices. For example, a clinical trial may be done to see how safe and effective a new medicine is.

A controlled research study for cancer treatment to determine the best possible treatment for a specific condition. These take place in many hospitals and cancer centers across the country, with sponsorship and review by the National Cancer Institute. In these clinical trials, doctors use the newest treatments to care for cancer patients. By agreeing to participate in a clinical trial, the patient agrees to follow the protocol of the specified drugs and to cooperate with the scientists to find new, improved treatments for cancer. Participation is voluntary in all clinical trials and patients may drop out of a clinical trial if they wish.

See "randomised controlled trial"

(98) - indicates the research study is a clinical trial, a randomized clinical trial, or a randomized controlled trial. Coordinate with the document type Research.

Systematic study of test article (treatment, drug, device) in one or more human subjects. Synonyms: clinical study, clinical investigation. (21 CFR 50.3)

Any investigation in humans meant to determine the clinical, pharmacological, pharmacokinetic, pharmacodynamic, and/or risk/benefit properties of a drug, device, or biologic

a study that is conducted to evaluate new treatment options, such as drugs or devices

Conflict of interest Consent: See informed consent. Contract research organization (CRO) Control group Controlled trial Cross-over trials

A scientific study conducted in people to determine the safety and effectiveness of a treatment.

A research study to test drugs, procedures, or testing technologies to determine how well they work compared to other practices.

Medical research undertaken with informed and consenting human subjects in a controlled environment. The intent of a clinical trial is for the sponsoring company or research institution to gather information on the safety and effectiveness of new drugs or therapies before seeking approval of a procedure or product for use by the Canadian public.

A study of how a drug will work in humans. Clinical trials usually involve many people and compare various end points such as safety and efficacy of a drug with a placebo or with other approved treatments.

A carefully designed experiment that allows scientists to test their research questions in people.

A study evaluating the effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people.

a study comparing two or more treatments and their outcomes

a research study involving humans that rigorously tests how well an intervention works.

a research study conducted to evaluate a new treatment or drug.

A test of a new or experimental drug in people. Also called drug trials or studies.

The most rigorous method for evaluating the safety and efficacy of a new drug, device, or surgical procedure on a group of individuals who are willing to participate and meet the eligibility requirements to be randomized. (See Randomization, below.)

controlled study designed to test the safety and efficacy of medicine in a set population of patients who have a specific illness. Close Window

A study to test an experimental medicine or treatment to see if it is safe and effective (see Phase I, Phase II, Phase III).

A scientific experiment that tests the effect of a drug in humans.

a research study that compares many children from around the world with the same type of cancer and evaluates their treatment, side effects, and survival.

A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment. Also called a clinical study.

a research study or experiment in humans (as opposed to animals) that is designed to answer specific questions.

A carefully planned study that evaluates the benefits and risks of treatments and screening tests on humans. Well-designed clinical trials are the fastest and safest way to find treatments that work in people. Clinical trials are also called research studies or medical research. Clinical trials are conducted in four phases

A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed.

Any planned therapeutic, diagnostic or preventive study involving people and comparing concurrently one intervention with another or with a placebo or with no intervention to determine their relative safety and efficacy.

A scientific means of testing the effectiveness and safety of a particular treatment. There are different phases of a clinical trial: Phase I Trial: Clinical research protocol to establish the toxicity of a new treatment. Phase II Trial: Clinical research protocol to establish the value of a new treatment. Phase III Trial: Clinical research protocol to improve present standard therapy.

Research studies test new drugs or treatments and compare them to current, standard treatments. Before a new treatment is used on people, it is studied in the lab. If lab studies suggest the treatment works, it is tested for patients. These human studies are called clinical trials.

Klin-ick-al Try-ul] The systematic investigation of the effects of specific treatments according to a formal research plan.

A research study to find better ways to prevent, detect, and treat cancer and to improve care for people with cancer.

A prospective study involving human research subjects designed to answer specific questions about the effects or impact of various interventions on the research subject.

An experiment to see how well a new drug works in people and how safe it is.

A test to see how well a new drug works in people and how safe it is.

Any investigation in human subjects intended to determine the clinical pharmacological, pharmacokinetic, and/or other pharmacodynamic effects of an investigational agent, and/or to identify any adverse reactions to an investigational agent to assess the agent's safety and efficacy.

The final stages of testing new drugs and or procedures in the treatment of diseases, including cancer. There are multiple forms of tests that can be run. People generally volunteer to be part of a test group.

A scientific research activity undertaken to define prospectively the effect and value of prophylactic, diagnostic, or therapeutic agents, devices, regimens, procedures, etc., applied to human subjects.

Unlike a therapeutic trial for the purpose of gaining approval to manufacture or market a drug, clinical trials in this sense use laboratory tests on blood or tissue samples from a patient to evaluate the performance of the testing method.

Testing therapies in human patients to ensure that treatments are safe and do not worsen the existing injury.

Clinical trials are used to test the safety and efficacy of a drug before it can be approved by the FDA. Please go to http://www.hepb.org/02-0143.hepb for hepatitis B drugs that are currently in clinical trial.

a method for testing an experimental drug. (see also Phase I, Phase II, Phase III)

an organized procedure for determining the effectiveness of a new drug or therapy by administering the agent to participants under strictly controlled conditions. In many clinical trials new agents are tested against older agents or an inactive substance (placebo). The clinical trials process includes Phase I, II and III trials and Phase IV postmarketing evaluation.

A clinical study, approved and monitored by an Institutional Review Board (IRB), designed for the purpose of evaluating the outcome of a new medical procedure.

A type of research study that uses volunteers to test new methods of screening, prevention, diagnosis, or treatment of a disease. The trial may be carried out in a clinic or other medical facility. Also called a clinical study. Return to Document

is a research study of how a new drug or treatment works on a disease or helps patients; also known as a clinical study.

A scientifically controlled study carried out under specific conditions, usually to test the effectiveness of a new treatment.

research study that involves patients.  Each study is designed to find better ways to prevent, detect, diagnose, or treat cancer and to answer scientific questions. Computed tomography:  X-ray procedure that uses a computer to produce a detailed picture of a cross section of the body; also called a CT or CAT scan.

When physicians want to learn if a therapy or medication works, they create a clinical trial to learn what will happen when patients are treated in a certain way. They closely examine what happens in groups of patients studied and followed over a period of time.

A well-defined scientific and ethical study of the effects of a particular treatment regime. Almost always, results are compared against a control group. Clinical trials are subject to very stringent regulation and codes of practice.

This type of experimental research uses people as subjects to evaluate the effectiveness and safety of a nutrient or medical treatment by monitoring its effect on the people participating in the clinical trial. Clinical trials may be small with a limited number of participants - or they may be large intervention trials seeking to discover the outcome of treatments on entire populations. The more participants in a study, the greater the likelihood that the study results can be replicated in the general population.

a test on thousands of volunteers to help determine whether a treatment is safe and effective.

Refer to explanation/diagram [link to Regulatory & Trials Process] in Clinical Development section

An organized research program conducted with patients to evaluate a new medical treatment, drug or device.

See: Clinical trials. See also: Inconclusive clinical trial; Negative clinical trial; Non-inferior clinical trial; Positive clinical trial.

A research study that attempts to improve current treatments or finds information on new treatments for patients with cancer.

A study done to test an experimental medicine in human beings to see if it is safe and effective.

An experimental research study that tests new medical interventions on people. These interventions may include drugs, devices, or other instruments.

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s) and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of one or more investigational medicinal product(s) with the object of ascertaining its/their safety and/or efficacy.

Investigation of the effects of a drug or other medical therapy on a group of people.

A research study that tests how well new medical treatments or other interventions work in people. Each study is designed to test new methods of screening, prevention, diagnosis, or treatment of a disease.

a prospective, scientific evaluation in human volunteers of a treatment regimen, device, or procedure used for the prevention, diagnosis, or treatment of a disease.

A medical study that tests the safety and effectiveness of a drug or treatment in people.

Also called a research study; a research program involving patients with a particular condition.

human study designed to measure the safety and efficacy of a new drug.

Scientific research conducted with patients, usually to evaluate a new treatment. Each trial is designed to answer specific questions and to find better ways to treat individuals with a specific disease. Many times cancer patients can receive new, experimental treatments by participating in a clinical trial.

Research conducted with the patient's permission which usually involves a comparison of two or more treatments or diagnostic methods. The aim is to gain better understanding of the underlying disease process and/or methods to treat it.

Research study that seeks to answer scientific questions and to find better ways to prevent or treat cancer.

A double blind controlled study that is characterized by its use of a large sampling of human subjects. Clinical trials are generally expensive and time-consuming due to their efforts to control confounding variables, to test alternative hypotheses, to replicate the study, and to offer evidence for the effectiveness of a claim.

A research study that tests the effectiveness of new treatments in people.

investigational studies of new treatments, new uses of existing treatment, or new screening methods to detect disease.

A test to see how well a new drug works on people (under tight government and clinical supervision.)

a research study using human volunteers to answer specific health questions. The clinical trials of the Salk vaccine used three groups: one received the vaccine, one received a placebo (harmless substance), one served as a control and was simply observed, receiving nothing. The trials were a double-blind study, meaning neither the experimenters nor the children knew who received what, with results revealed at the end of the trial.

A controlled study to look at the effectiveness of a specific ingredient or application

A clinical trial is structured research to answer specific questions about new drugs and therapies. Clinical trials are conducted to determine the effectiveness and safety of new drugs or treatments, or to find new applications for existing drugs.

a scientifically controlled study of the safety and effectiveness of a therapeutic agent (as a drug or vaccine) using consenting human subjects

the study of the effects of drugs, equipment, or procedures according to a formal research plan for a particular disease or group of diseases; a research study meant to help improve current treatments or obtain information on new treatments. Clinical trials are taking place testicular cancer over the country. Information about ongoing clinical trials is available from the National Cancer Institute Website

Research studies that use human beings (rather than animals). Clinical trials are conducted in health care settings with voluntary patient-participants.

a carefully controlled study designed to test whether an intervention, such as a drug, is safe and effective in human beings.

Research programs on new or existing products to test their effectiveness and safety, and to look for side effects, where the test subjects are people (who volunteer) rather than animals (who do not). Some of these people will receive the real product and some, merely a placebo (a fake substitute). (See Placebo).

A clinical trial involves administering a treatment to test it. It is an experiment. Clinical trial is an umbrella term for a variety of health care trials, whether controlled or uncontrolled. Types include uncontrolled trials, controlled clinical trials (CCT), community trials, and randomised controlled trials (RCT). A clinical trial is also sometimes called a 'therapeutic trial'.

An investigation in respect of a natural health product that involves human subjects and that is intended to discover or verify its clinical, pharmacological or pharmacodynamic effects, to identify any adverse events that are related to its use, to study its absorption, distribution, metabolism and excretion, or to ascertain its safety or efficacy.

A study (experiment) in humans that evaluates a diagnostic or therapeutic product.

A contract to test drugs, devises, or other controlled substances for FDA approval or for-profit corporations. This contract usually involves the use of human or animal subjects.

a research program conducted with patients to evaluate a new medical treatment, drug, or device. The purpose of clinical trials is to find new and improved methods of treating different diseases and special conditions.

a research study, generally used to evaluate the effectiveness of a new treatment in human participants. Clinical trials are designed to answer specific scientific questions and to determine the efficacy of new treatments for specific diseases or health conditions.

Clinical trials are research studies that evaluate new treatment options. Clinical trials are conducted in health care settings with voluntary patient-participants.

An experimental study of a drug or procedure in which the subjects are humans.

A medical study that evaluates the safety and effectiveness of a treatment or drug. Each trial is designed to answer scientific questions and to find better ways to treat people with a specific illness.

An organized test put together to show if a treatment works. It usually is made up of patients who are divided into 2 groups: a test group and a control group. At the end of the trial, the groups are compared to see if there was any difference in their outcomes. A randomized clinical trial is when patients are randomly selected to be included in the trial. This is done so that as broad a group of patients as possible can participate.

A research study done on human volunteers to decide if a new treatment is safe and effective

A research study that attempts to improve current treatments or finds information on new treatments for particular diseases.

A research protocol that is designed to answer a question regarding a population of patients with disease or who are at risk for disease.

There are three phases to a human clinical trial. Clinical trials are designed to evaluate the effectiveness, both positive and negative, of a new drug in a human population.

A research study in which a new treatment is given to patients to determine whether it is safe, more effective, or less toxic than a current standard of care.

Clinical trials are scientific studies designed to test whether a new medical treatment is safe and effective. There are four phases of clinical trials. Phase I is a small study that looks at safety only. Phase II looks at safety and efficacy (whether or not it works). Phase III is a large study that's the last step before approval by the FDA, or a similar regulatory agency in other countries. Phase IV monitors the treatment's long-term safety and efficacy after it has been approved for consumers.

A research study that evaluates the effectiveness of new interventions in people. Each study is designed to evaluate new methods of screening, prevention, diagnosis, or treatment of cancer.

Test that is intended to evaluate how well a drug will work in humans. Clinical trials are often conducted with many people and compare a treatment or a way of treating a disease with either a sugar pill or other, approved treatments.

Experimentation with new drugs or treatment to evaluate their effectiveness in curing a disease.

a carefully planned experiment to evaluate a treatment or a medication (often a pharmaceutical drug) for an unproven use.

A scientific study that tests the effectiveness of a new medical treatment, drug, or device with patients.

therapeutic assessment in patients of a new gene therapy strategy (in our context).

A research study in which a treatment or therapy is tested in people to see whether it is safe and effective. Clinical trials are a key part of the process in finding out which treatments work, which do not, and why. Clinical trial results also contribute new knowledge about diseases and medical conditions.

The systematic investigation of the effects of specific treatments according to a formal research plan in patients with a particular disease or class of diseases. In cancer research, a clinical trial generally refers to the evaluation of treatment methods such as surgery, drugs, or radiation techniques, although methods of prevention, detection, or diagnosis also may be the subject of such trials.

A type of research study that uses volunteers to test the safety and efficacy (the ability to produce a beneficial effect) of new methods of screening (checking for disease when there are no symptoms), prevention, diagnosis, or treatment of a disease. Also called a clinical study.

A clinical trial is a contract supported by a corporation, generally a pharmaceutical company, that involves evaluation by the university of the corporation's technology or product. Clinical trials almost always involve animal or human subjects. Clinical trials are processed by the Clinical Trials Office.

A medical investigational study in which humans are observed and/or treated. A study may investigate a new treatment, prevention strategy, diagnostic method, screening procedure, or how to improve comfort and quality of life.

Clinical trials are research studies to test new types of treatments, preventions and diagnoses on patients.

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s) and/or to study absorption, distribution, metabolism and excretion of an investigational product(s) with the objective of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous

A study conducted using patients, usually to evaluate a new treatment.

A scientifically controlled study carried out in people with a particular disease or class of diseases, usually to test the effectiveness of a new treatment. In cancer research, a clinical trial generally refers to the evaluation of treatment methods such as surgery, drugs or radiation techniques, although methods of prevention, detection or diagnosis may also be the subject of such studies.

In medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a type of research study. The most commonly performed clinical trials evaluate new drugs, medical devices, biologics, or other interventions on patients in strictly scientifically controlled settings, and are required for regulatory authority (in the USA, the Food and Drug Administration; in Canada, Health Canada; in the EU, the European Medicines Agency; in Japan, the Ministry of Health, Labour and Welfare (Japan)) approval of new therapies. Trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions.