The clinical study is ongoing (that is, participants are receiving an intervention or being examined), but potential participants are not currently being recruited or enrolled.

Source: ClinicalTrials.gov

Acute cutaneous LE typically presents in the third decade of life and is frequently associated with active SLE. There are localized and generalized forms of ACLE. The localized form is the frequently described malar, or “butterfly” rash, which refers to erythema that occurs over both cheeks, extends over the nasal bridge, and spares the nasolabial folds. These lesions are classically transient, sun-induced, and non-scarring, although dyspigmentation can occur. Patients may initially mistake this rash for a sunburn, and only seek medical attention when it persists for several days. A fine surface scale and/or edema may be associated with the erythema. Malar rashes have been reported to be present in up to 52% of SLE patients at the time of diagnosis, with clinical activity of the rash paralleling that of the systemic disease. This rash can be confused with acne rosacea and seborrheic dermatitis, however the former is associated with the formation of papules and pustules, and the latter occurs within the nasolabial folds.

Source: NIH.gov

An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study is over. This may or may not be caused by the intervention being studied. Also called adverse effect.

Source: ClinicalTrials.gov

Any of a group of autoantibodies that react against normal components of the cell nucleus. They are present in several immunologic diseases, including systemic lupus erythematosus, progressive systemic sclerosis, Sjögren syndrome, scleroderma, polymyositis, and dermatomyositis, and in some patients taking hydralazine, procainamide, or isoniazid. In addition, ANA is present in some normal people. Tests for ANAs are used in the diagnosis and management of autoimmune diseases.

Source: Taber’s

A group or subgroup of participants in a clinical trial who receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins.

Source: ClinicalTrials.gov

An antibody made against substances formed by a person’s own body. Autoantibodies can directly destroy cells that have the substances on them or they can make it easier for other white blood cells to destroy them. Some autoimmune diseases are caused by autoantibodies.

Source: NCI

A disease that results when the immune system mistakenly attacks the body’s own tissues. Examples include multiple sclerosis, type 1 diabetes, rheumatoid arthritis, and systemic lupus erythematosus. Autoimmune diseases can affect almost any part of the body, including the heart, brain, nerves, muscles, skin, eyes, joints, lungs, kidneys, glands, the digestive tract, and blood vessels.

The classic sign of an autoimmune disease is inflammation, which can cause redness, heat, pain, and swelling.

How an autoimmune disease affects you depends on what part of the body is targeted. Many autoimmune diseases don’t restrict themselves to one part of the body. For example, SLE can affect the skin, joints, kidneys, heart, nerves, blood vessels, and more.

Source: NIH.gov

The body’s tolerance of the antigens present on its own cells, i.e., autoantigens or self-antigens. It is theorized that autoreactive T lymphocytes are destroyed in the thymus by negative selection or in peripheral blood. Autoreactive T cells that escape destruction in the thymus may become tolerant because they are exposed to thousands of autoantigens as they circulate in the blood.

The loss of self-tolerance is believed to be due to many hereditary and environmental factors and occurs when autoantigens are damaged, when they link with a foreign antigen, when the structure of an autoantigen is very similar to that of a foreign antigen (molecular mimicry), or when autoreactive T cells are not adequately controlled or are activated by nonspecific antigens. The changes in the appearance of the autoantigen or activation of autoreactive T-cells result in autoantigens being perceived as foreign. Inflammation and destruction of the tissues bearing the antigen occur because of the production of autoantibodies by B cells or the cytotoxicity of autoreactive T cells, which attack the autoantigens.

Source: Taber’s

Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age and gender, and study-specific measures (for example, blood pressure, prior antidepressant treatment).

Source: ClinicalTrials.gov

A clinical trial design strategy in which one or more parties involved with the trial, such as the investigator or participant, do not know which participants have been assigned which interventions.

Source: ClinicalTrials.gov

The central nervous system is made up of the brain and spinal cord. The brain functions to receive nerve impulses from the spinal cord and cranial nerves. The spinal cord contains the nerves that carry messages between the brain and the body.

In some patients, lupus affects the brain or central nervous system. This can cause headaches, dizziness, depression, memory disturbances, vision problems, seizures, stroke, or changes in behavior.

Source: NIAMS.NIH.gov, MedlinePlus.gov

Chronic cutaneous lupus erythematosus (CCLE) is a form of cutaneous lupus erythematosus (CLE) that includes five different forms: discoid lupus erythematosus (DLE), chilblain lupus, hypertrophic or verrucous lupus erythematosus, lupus erythematosus tumidus, and lupus erythematosus panniculitis.

Source: NIH.gov

A health professional who works directly with patients, or uses data from patients, to do research on health and disease and to develop new treatments. They may also do research on how health care practices affect health and disease.

Source: NCI

A research study using human subjects to evaluate the effect of interventions or exposures on biomedical or health-related outcomes. Two types of clinical studies are interventional studies (or clinical trials) and observational studies.

Source: ClinicalTrials.gov

A clinical trial is a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.

Source: NIH.gov

A part of the clinical research process that answers specific questions about whether treatments or other interventions that are being studied are safe and work. Phase I trials test the best way to give a new treatment and the best dose. Phase II trials test whether a new treatment has an effect on the disease. Phase III trials compare the results of people taking a new treatment with the results of people taking the standard treatment. Phase IV trials are done using many people after a treatment has been approved and marketed to check for side effects that weren’t seen in the Phase III trial.

Source: NCI

A person, company, institution, group, or organization that oversees or pays for a clinical trial and collects and analyzes the data. Also called trial sponsor.

Source: NCI

Clinical studies that are no longer recruiting participants because they have enough participants already, because they are completed, or because they have been stopped for some reason. This also describes studies with very specific eligibility criteria that recruit participants by invitation only. Recruitment statuses for closed studies appear in red text in ClinicalTrials.gov search results and study records.

Source: ClinicalTrials.gov

A group of individuals who share a common trait, such as birth year. In medicine, a cohort is a group that is part of a clinical trial or study and is observed over a period of time.

Source: NIH.gov

A research study that compares a particular outcome in groups of individuals who are alike in many ways but differ by a certain characteristic.

Source: NCI

A collaborator is an organization other than the sponsor that provides support for a clinical study. This may include funding, design, implementation, data analysis, or reporting.

Source: ClinicalTrials.gov

The term “comorbidity” describes two or more disorders or illnesses occurring in the same person. They can occur at the same time or one after the other. Comorbidity also implies interactions between the illnesses that can worsen the course of both.

Source: NIH.gov

A process in which patients are given important information such as possible risks and benefits, about a medical procedure or treatment, genetic testing, or a clinical trial. This is to help the patient decide if they want to be treated, tested, or take part in the trial. Patients are also given any new information that might affect their decision to continue. This is also called informed consent.

Source: NCI

A type of clinical trial in which observations made during the trial are compared to a standard (called the control). The control may be observations from a group of participants in the same trial or observations from outside the trial (for example, from an earlier trial, called a “historical control”).

Source: ClinicalTrials.gov

Cutaneous lupus causes a rash or lesion on the skin, usually when exposed to sunlight. One of the common types of skin lupus is called discoid lupus erythematosus (DLE). It is identified by a rash that appears on the face, neck, or scalp, and by hair loss.

A data monitoring committee (DMC) is a group of clinicians and biostatisticians appointed by study sponsors who provide independent assessment of the safety, scientific validity and integrity of clinical trials.

Source: NIH.gov

Cutaneous lesion that develops as a dry, scaly, red patch that evolves to an indurated and hyperpigmented plaque with adherent scale. Scarring may result in central white patches (loss of pigmentation) and skin atrophy.

Source: NIH.gov

A type of clinical trial in which neither the researcher doing the study nor the patients know the specific type of treatment each patient receives until after the clinical trial is over. This type of study is done to make sure the study results are not biased.

Source: NCI

Drug-induced lupus is much less common and is caused by an overreaction to certain types of medication. Its symptoms are like those of SLE, but they typically disappear once the medicine is stopped.

Source: NIH.gov

A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies)

Source: ClinicalTrials.gov

The key standards that people who want to participate in a clinical study must meet or the characteristics that they must have. These include inclusion criteria and exclusion criteria. For example, a study might only accept participants who are above or below certain ages.

Source: ClinicalTrials.gov

In clinical trials, an event or outcome that can be objectively measured to determine whether the intervention being studied is beneficial. The endpoints are usually included in the study objectives.

Source: NCI

The number of participants in a clinical study. The “estimated enrollment” is the number of participants that the researchers need for the study to provide valuable data.

Source: ClinicalTrials.gov

A type of eligibility criteria. The factors (or reasons) that prevent a person from participating in a clinical study.

Source: ClinicalTrials.gov

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the FDA. This is also known as compassionate use.

Source: ClinicalTrials.gov

In clinical trials, refers to a drug or procedure that has undergone basic laboratory testing and received approval from the U.S. FDA to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but experimental in another. Also called investigational.

Source: NCI

A group of participants that receives the intervention that is the focus of the study.

Source: ClinicalTrials.gov

A substance that has been tested in the laboratory and has been approved by the US FDA for testing in people. Clinical trials test how well experimental drugs work and if they are safe to use. An experimental drug can be approved for one disease but considered investigational in another. Also called IND, investigational agent, investigational drug, and investigational new drug.

Source: NCI

The group in a clinical research study that receives the drug, vaccine, or other intervention being tested. It is also called the intervention group and investigational group.

Source: NCI

Fatigue is different from drowsiness. Drowsiness is feeling the need to sleep. Fatigue is a lack of energy and motivation. Drowsiness and apathy (a feeling of not caring about what happens) can be symptoms that go along with fatigue. Fatigue can be a normal and important response to physical activity, emotional stress, boredom, or lack of sleep. Fatigue is a common symptom, and it is usually not due to a serious disease. But it can be a sign of a more serious mental or physical condition. When fatigue is not relieved by enough sleep, good nutrition, or a low-stress environment, it should be evaluated by your doctor.

Source: NIH.gov

The U.S. Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

FDA also plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

Source: FDA.gov

In a clinical study, a person who does not have the disorder or disease being studied. Results from healthy controls are compared to results from the group being studied.

Source: NCI

A group of people who review, approve, and monitor the clinical study protocol. Their role is to protect the rights and welfare of human research subjects participating in a study. The group typically includes people with varying backgrounds, including a community member, to make sure that research activities conducted by an organization are completely and adequately reviewed. Also known as an institutional review board (IRB) or ethics committee.

Source: ClinicalTrials.gov

The goal of the informed consent process is to protect participants. It begins when a potential participant first asks for information about a study and continues throughout the study. The researcher and potential participant have discussions that include answering the participant’s questions about the research. All the important information about the study must also be given to the potential participant in a written document that is clear and easy to understand. This informed consent document is reviewed and approved by the human subjects review board for a study before it is given to potential participants. Generally, a person must sign an informed consent form to enroll in a study.

Source: ClinicalTrials.gov

ICF, the document used in the informed consent process

Source: ClinicalTrials.gov

A group of scientists, doctors, clergy, and patient advocates that reviews and approves the detailed plan for a clinical trial. IRBs are meant to protect the individuals who take part in a clinical trial. They make sure that the trial is well designed, legal, ethical, does not involve unneeded risks, and includes a safety plan for patients. There is an IRB at every health care facility that does clinical research, and every trial is reviewed by an IRB before the trial begins.

Source: NCI

A process or action that is the focus of a clinical study. This can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches such as surveys, education, and interviews.

Source: ClinicalTrials.gov

The group in a clinical research study that receives the drug, vaccine, or other intervention being tested. It is also called the experimental group and investigational group.

Source: NIH.gov

A substance that has been tested in the laboratory and has been approved by the US FDA for testing in people. Clinical trials test how well experimental drugs work and if they are safe to use. An experimental drug can be approved for one disease but considered investigational in another. Also called experimental drug, IND, investigational agent, investigational new drug.

Source: NCI

The group in a clinical research study that receives the drug, vaccine, or other intervention being tested. It is also called the intervention group and experimental group.

Source: NCI

A substance that has been tested in the laboratory and has been approved by the U.S. FDA for testing in people. Clinical trials test how well experimental drugs work and if they are safe to use. An experimental drug can be approved for one disease but considered investigational in another. Also called experimental drug, IND, investigational agent, investigational drug.

Source: NCI

In research, a person who is involved in running a clinical trial or research study. The investigator may help prepare and carry out the protocol, or plan, for the study, monitor the safety of the study, collect and analyze the data, and report the results of the study. Investigators can include doctors, scientists, nurses, and other research staff. Some clinical trials have more than one investigators, and usually one of the investigators is the principal investigator, who is in charge of the whole study.

Source: NCI

The malar rash, or butterfly rash, is a red flat facial rash involving the malar region bilaterally and the bridge of the nose. The presence of a butterfly rash is generally a sign of lupus erythematosus (LE), but it can also include a plethora of conditions.

Source: NIH.gov

A clinical trial design strategy in which one or more parties involved in the trial (investigator or participants) do not know which participants have been assigned which interventions. Types include: open label, single-blind masking, and double-blind masking.

Source: ClinicalTrials.gov

Neonatal lupus occurs when an infant passively acquires auto-antibodies from a mother with SLE. Any skin, liver, and blood problems resolve by 6 months, but the most serious sign—congenital heart block—requires a pacemaker and has a mortality rate of about 20%

Source: CDC.gov

Lupus nephritis is kidney inflammation caused by SLE Up to 60 percent of people with SLE are diagnosed with lupus nephritis.

Source: NIH.gov

For people with joint or chest pain or fever, drugs that decrease inflammation, called nonsteroidal anti-inflammatory drugs (NSAIDs), are often used. Although some NSAIDs, such as ibuprofen and naproxen, are available over the counter, a doctor’s prescription is necessary for others. NSAIDs may be used alone or in combination with other types of drugs to control pain, swelling, and fever. Even though some NSAIDs may be purchased without a prescription, it is important that they be taken under a doctor’s direction.

Source: NIAMS.NIH.gov

A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study).

Source: ClinicalTrials.gov

Describes the legal use of a prescription drug to treat a disease or condition for which the drug has not been approved by the U.S. FDA.

Source: NCI

The Office within the U.S. Department of Health and Human Services that protects the rights, welfare, and well-being of people involved in clinical trials.

Source: NCI

Describes a clinical trial in which masking is not used. That means that all parties involved with the trial know which participants have been assigned which interventions.

Source: ClinicalTrials.gov

Studies that are currently recruiting participants, will be recruiting participants in the future, or involve drugs that are available for expanded access.

Source: ClinicalTrials.gov

A type of study in which both the health providers and the patients are aware of the drug or treatment being given.

Source: NCI

A specific result or effect that can be measured.

Source: NCI

A planned measurement described in the protocol that is used to determine the effect of interventions on participants in a clinical trial. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment.

Source: ClinicalTrials.gov

Outcomes research seeks to understand the end results of specific health care practices and interventions. End results include effects that people experience and care about, such as change in the ability to function.

Source: HHS.gov

Describes a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel design involves two groups of participants. One group receives drug A, and the other group receives drug B. During the trial, participants in one group receive drug A “in parallel” to participants in the other group receiving drug B.

Source: ClinicalTrials.gov

The stage of a clinical trial studying a drug or biological product, based on definitions by the FDA. The phase is based on the study’s objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4.

The first step in testing a new treatment in humans. A Phase I study tests the safety, side effects, best dose, and timing of a new treatment. It may also test the best way to give a new treatment and how the treatment affects the body. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Phase I clinical trials include only a small number of patients who have not been helped by other treatments. Sometimes they include healthy volunteers.

Source: NCI

A study that tests the safety, side effects, and best dose of a new treatment. Phase I/II clinical trials also test how well a certain type of disease responds to a new treatment. In the phase II part of the clinical trial, patients usually receive the highest dose of treatment that did not cause harmful side effects in the phase I part of the clinical trial. Combining phases I and II may allow research questions to be answered more quickly or with fewer patients.

Source: NCI

A study that tests whether a new treatment works for a certain type of disease. Phase II clinical trials may also provide more information about the safety of the new treatment and how the treatment affects the body.

Source: NCI

A study that tests how well a new treatment works for a certain disease and compares the new treatment with a standard treatment. Phase II/III clinical trials may also provide more information about the safety and side effects of the new treatment. Combining phases II and III may allow research questions to be answered more quickly or with fewer patients.

Source: NCI

A study that tests the safety and how well a new treatment works compared with a standard treatment. In most cases, treatments move into phase III trials only after they meet the goals of phase I and II trials. Phase III clinical trials may include hundreds of people.

Source: NCI

A type of clinical trial that studies the side effects caused over time by a new treatment after it has been approved and is on the market. These trials look for side effects that were not seen in earlier trials and may also study how well a new treatment works over a long period of time. Phase IV clinical trials may include thousands of people. Phase IV trials are also called post-marketing surveillance trials.

Source: NCI

An inactive substance or other intervention that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or other intervention are compared to the effects of the placebo.

Source: NCI

An inactive treatment or procedure that is intended to mimic as closely as possible a therapy in a clinical trial.

Source: NCI

Refers to a clinical study in which the patients in the control group receive a placebo.

Source: NCI

A study of a group of individuals taken from the general population who share a common characteristic, such as age, sex, or health condition. This group may be studied for different reasons, such as their response to a drug or their risk of getting a disease.

Source: NCI

Research using animals to find out if a drug, procedure, or treatment is likely to be useful. Preclinical studies take place before any testing in humans is done.

Source: NCI

The main result that is measured at the end of a study to see if a given treatment worked. What the primary endpoint will be is decided before the study begins.

Source: NCI

The planned outcome measure in the protocol (design for the study) that is the most important for evaluating the effect of an intervention. Most clinical studies have one primary outcome measure, but some may have more than one.

Source: ClinicalTrials.gov

The main reason for the clinical trial. The types of primary purpose are: treatment, prevention, diagnostic, supportive care, screening, health services research, basic science, and other.

Source: ClinicalTrials.gov

The person who is responsible for the scientific and technical direction of the entire clinical study.

Source: ClinicalTrials.gov

The written description of a clinical study. It includes the study’s objectives, design, and methods. It may also include relevant scientific background and statistical information.

Source: ClinicalTrials.gov

In biology, a term used to describe a group of people who share similar physical characteristics or genetic traits. These may include skin, hair, and eye color, facial features, and body type. Examples of races include Blacks and Caucasians. Some diseases or genetic conditions may be more common in certain races than in others.

Source: NCI

When referring to an experiment or clinical trial, the process by which animal or human subjects are assigned by chance to separate groups that compare different treatments or other interventions. Randomization gives each participant an equal chance of being assigned to any of the groups.

A strategy in which participants are assigned to arms of a clinical trial by chance.

Source: ClinicalTrials.gov

A study in which participates are divided by chance into separate groups that compare treatments or other interventions. Using chance to divide people into groups means the groups will be similar and the potential effects of the treatment can be compared more fairly. At the time of the trial it is not known which treatment is best.

Source: NIH.gov

A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes or groups of people by looking at data collected in the past or future.

Source: NCI

Looking back at events that have already taken place.

Source: NCI

A research study in which the past medical records of groups of individuals who are alike in many ways but differ by a certain characteristic are compared for a particular outcome. Also called historic cohort study.

Source: NCI

A study that compares two groups of people: those with the disease or condition under study (cases) and a very similar group of people who do not have the disease or condition (controls). Researchers study the medical and lifestyle histories of the people in each group to learn what factors may be associated with the disease or condition. For example, one group may have been exposed to a particular substance that that the other group was not exposed to. This is also called a case-control study.

Source: NCI

A planned outcome measure in the protocol that is not as important as the primary outcome measurebut is still of interest in evaluating the effect of an intervention. Most clinical studies have more than one secondary outcome measure.

Source: ClinicalTrials.gov

An error in choosing the individuals or groups to take part in a study. Ideally, the subjects in a study should be very similar to one another and to the larger population from which they are drawn. If there are important differences, the results of the study may not be valid.

Source: NCI

An adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.

Source: ClinicalTrials.gov

A problem that occurs when treatment affects healthy tissues or organs.

Source: NCI

A type of clinical trial in which only the researcher doing the study knows whether a patient is receiving the standard treatment or the new treatment being tested. This helps to prevent bias in treatment studies.

Source: NCI

The organization or person who initiates the study and who has authority and control over the study.

Source: ClinicalTrials.gov

Treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals. Also called best practice, standard medical care, and standard therapy.

Source: NCI

A medicine, vitamin, mineral, food supplement, or a combination of them that is being tested in a clinical trial.

Source: NCI

The date that the final data for a clinical study were collected because the last study participant has made the final visit to the study location (that is, “last subject, last visit”). The “estimated study completion date” is the date that researchers think will be the completion date for the study.

Source: ClinicalTrials.gov

The investigative methods and strategies used in the clinical study.

Source: ClinicalTrials.gov

Refers to the type of documents that the study sponsor or PI may add to their study record. These include a study protocol, statistical analysis plan, and an informed consent form.

Source: ClinicalTrials.gov

Describes the nature of a clinical study, such as interventional studies (also called clinical trials), observational studies, and expanded access.

Source: NCI

As with SLE, Subacute Cutaneous Lupus Erythematosus (SCLE) occurs primarily in young to middle aged women. SCLE is highly photosensitive, with 70-90% of patients meeting the ACR definition of abnormal photosensitivity.

Source: NIH.gov

The clinical study has stopped recruiting or enrolling participants early, but it may start again.

Source: ClinicalTrials.gov

SLE is the most common type of lupus. It can affect many parts of the body including the kidneys, heart, lungs, brain, blood, and skin.

The clinical study has stopped recruiting or enrolling participants early and will not start again. Participants are no longer being examined or treated.

Source: ClinicalTrials.gov

A person, company, institution, group, or organization that oversees or pays for a clinical trial and collects and analyzes the data. Also called clinical trial sponsor.

Source: NCI

A clinical study that lacks a comparison (i.e. a control) group.

Source: NCI

The clinical study stopped before enrolling its first participant.

Source: ClinicalTrials.gov