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    Understanding Clinical Studies

      Axiom > Understanding Clinical Studies
    Clinical Researh
    Clinical Research
    Understanding Clinical Studies and Clinical Trials

    Understanding Key Terms in Clinical Research

    While the term “clinical trial” is commonly used and familiar to many, it’s important to understand the broader terminology used in medical research. Knowing these distinctions can help you have more informed conversations with your healthcare provider or research team.

      What is a Clinical Study?
      A clinical study (also referred to as clinical research) is medical research involving human participants. These studies aim to discover better methods to diagnose, treat, prevent, or understand disease. Individuals volunteer to take part in these studies to help advance medical knowledge. There are two main types of clinical studies:

    Interventional Clinical Trials

    In an interventional study, researchers actively introduce an intervention,such as a treatment or procedure,to study its effects. These interventions may include:

    • A medical product, drug, or device
  • A procedure (e.g., a new method to prevent falls)
  • A change in behavior (e.g., a specific diet or lifestyle plan)

    • Example:
    A study tests whether a new cancer medication is as effective as the current standard treatment.

    Observational Studies

    In observational studies, researchers collect health-related information from participants without assigning specific treatments or making changes to their medical care. The goal is to observe outcomes as they naturally occur.

    Example:
    A study monitors a group of older adults over time to examine how different lifestyles impact heart health. Researchers may collect blood samples, but the results are used purely for analysis, not to make changes to the participant’s care.

    Phase 1: Safety & Dosage
    • Participants: 20–100 healthy volunteers or patients

    Purpose: To evaluate the safety of a new drug or treatment, determine a safe dosage range, and identify potential side effects.

    • Participants: 100–300 individuals with the targeted condition

    Purpose: To assess how well the drug or treatment works, while continuing to evaluate its safety and monitor for side effects.

    • Participants: 1,000–3,000 individuals

    Purpose: To confirm effectiveness, monitor adverse reactions, and compare the new treatment to standard therapies. The results help determine if the drug should be approved for public use.

    • Participants: General population

    • Purpose: Conducted after FDA approval, Phase 4 studies gather additional information on long-term effectiveness, risks, and optimal usage in real-world settings.

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