Key Terms for Clinical Trials - HealthTree for Multiple Myeloma
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Key Terms

Last updated on: 1/8/2025

Clinical trials have a specific terminology to describe the researchers' work. As you navigate through different clinical trials, you might come across these terms: 

  • Adverse Event (AE)
    Any undesirable experience or side effect that happens during a clinical trial. An adverse event may or may not be related to the treatment being tested.
  • Arm 
    Participants are usually divided into different groups, known as "arms." Each arm receives a specific treatment or no treatment at all, depending on the trial's design. 

  • Blinded/Double-Blinded
    In blinded studies, patients don’t know their group; in double-blinded studies, neither patients nor researchers know. This helps prevent bias in the treatment administration or data collection.

  • Cohort
    A group of participants who share certain characteristics, such as the same disease or condition, and are treated or monitored in the same way during a clinical trial.
  • Clinical Investigator
    A doctor or healthcare professional is responsible for overseeing the trial and ensuring that it is conducted according to the protocol.
  • Clinical Trial
    A research study that tests how well new medical approaches, treatments, medications, or devices work in people. Clinical trials follow strict guidelines to ensure patient safety and scientific accuracy.
  • Control Group
    A group of participants who receive either a placebo or the standard treatment, rather than the new experimental treatment being tested. Comparing the control group to the experimental group helps researchers understand the effects of the new treatment.
  • Dose
    The amount of the medication or treatment being given to participants in the trial. This can vary depending on the study design and what researchers are testing.
  • Eligibility Criteria
    The specific conditions or characteristics that a person must meet to join a clinical trial, such as age, gender, medical history, or type of disease. These criteria help ensure that the trial participants are appropriate for the study's goals.
  • Efficacy
    The ability of a treatment to produce the desired or expected result in clinical trials. This is typically measured against a placebo or standard treatment to determine how well the new treatment works.
  • Ethics Committee
    A group of medical professionals, researchers, and community members who review and approve clinical trials to ensure they are ethical and safe. They focus on protecting the rights, safety, and well-being of participants, especially vulnerable groups like myeloma patients.
  • Exclusion Criteria
    Factors that would prevent a person from participating in a clinical trial, such as certain medical conditions, medications, or previous treatments that could interfere with the study.
  • Gold Standard
    The most reliable and accepted method or treatment currently available in medicine. It is often used as a comparison in clinical trials to measure the effectiveness of new treatments or procedures. For example, in multiple myeloma trials, a widely used "gold standard" might involve a well-established combination of medications.
  • Hazard Ratio 
    Definition: A statistical measure used to compare the rate of events (e.g., death or disease progression) in two groups. An HR less than 1 indicates that the treatment group has a lower risk of the event compared to the control group, while an HR greater than 1 suggests a higher risk. For example, an HR of 0.75 in a cancer trial would indicate that the treatment group has a 25% lower risk of progression or death compared to the control group.
  • Inclusion Criteria
    The characteristics or conditions that a participant must have to be eligible to join the trial. For example, a trial might require participants to have a specific condition or disease.
  • Informed Consent
    A process in which a participant learns about the clinical trial, including its purpose, potential risks, and benefits, and voluntarily agrees to take part. Informed consent does not mean giving up legal rights but agreeing to participate with full knowledge of what’s involved.
  • Intervention
    The treatment, procedure, or approach being tested in the trial. This could be a new medication, device, therapy, or lifestyle change.
  • Kaplan-Meier Curve (Survival Curve)
    Definition: A graphical method for estimating and visualizing the survival function from clinical trial data. It plots the probability of survival over time for a group of patients, allowing for comparison between treatment groups.
  • Log-Rank Test
    Definition: A statistical test used to compare the survival distributions of two or more groups. It’s commonly applied to the Kaplan-Meier survival curves to determine if there is a significant difference in survival between treatment groups.
  • Monitoring
    The process of checking participants' health during the trial to ensure safety and evaluate the treatment’s effects. This may include regular visits, lab tests, and evaluations.
  • Placebo
    An inactive substance or treatment that looks identical to the actual treatment being tested but has no therapeutic effect. Placebos are used in trials to help compare the real treatment’s effectiveness. They are rarely used in cancer trials; placebos are only used alongside proven therapies, not instead of them.
  • Principal Investigator (PI)
    The doctor or researcher in charge of running the clinical trial at a specific location. They ensure the trial is conducted safely and according to the study plan, protect patients' rights, and are the main point of contact for any trial-related questions.
  • Protocol
    A detailed plan or set of rules that outline how a clinical trial will be conducted. It includes information on the trial's objectives, design, and procedures for treating participants.
  • Randomization
    The process of assigning participants to different groups (such as the treatment group or the placebo group) by chance rather than by choice. This helps eliminate bias and ensures that the groups are comparable at the start of the trial.
  • Randomized/Non-Randomized
    Assignment to treatment or control groups is either random or chosen.

  • Results or Findings
    The data collected during a clinical trial that is analyzed to determine whether the treatment is effective and safe. These results are often published once the trial is completed.
  • Safety Profile
    An assessment of the risks or potential side effects of a treatment, including how common or severe the side effects may be.
  • Serious Adverse Event (SAE)
    An adverse event that is severe and results in significant consequences, such as hospitalization, permanent damage, or death. These events must be reported immediately to ensure patient safety.
  • Sponsor
    The organization or individual responsible for funding and managing the clinical trial. Sponsors can include pharmaceutical companies, research institutions, or government agencies. They provide the resources to conduct the trial but do not interfere with patient care.