SP
BravenNow
Phases of clinical research
🌐 Entity

Phases of clinical research

Clinical trial stages using human subjects

📊 Rating

2 news mentions · 👍 0 likes · 👎 0 dislikes

💡 Information Card

Who / What

The Phases of clinical research are a structured set of stages used to evaluate the safety and efficacy of health interventions—such as drugs, vaccines, medical devices, and diagnostic assays—in human subjects. They provide a systematic framework for collecting the evidence required to determine whether an intervention can be considered an effective medical treatment.


Background & History

The phases emerged as a formal classification to bring consistency to the evaluation of health interventions in people. This sequential approach allows researchers to start with a small group to assess safety and then expand to larger populations to measure effectiveness. It has become a core element of drug and device development programs worldwide. The specific historical origins and key milestones are not detailed in the source material.


Why Notable

These phases deliver a standardized method for generating robust evidence that regulatory agencies require for approval and public‑health protection. By breaking evaluation into distinct stages, safety issues can be identified early while efficacy is rigorously tested before wide use. The framework also supports transparency, comparability across studies, and applies to a broad range of health interventions.


In the News

The provided source does not contain information about recent developments or news related to the phases of clinical research.


Key Facts

  • **Type:** organization (conceptual framework)
  • **Also known as:** Clinical trial phases; Phases I–IV; Clinical development phases
  • **Founded / Born:** Not applicable (conceptual)
  • **Key dates:**
  • **Phase I:** Initial safety testing in a few human subjects.
  • **Phase II:** Larger cohort to assess efficacy and further safety.
  • **Phase III:** Large‑scale confirmation of efficacy and monitoring of adverse reactions (potentially tens of thousands of participants).
  • **Phase IV:** Post‑marketing surveillance after regulatory approval.
  • **Geography:** Not applicable
  • **Affiliation:** Field of clinical research and drug development

  • Links

  • [Wikipedia](https://en.wikipedia.org/wiki/Phases_of_clinical_research)
  • Sources

    📌 Topics

    • Clinical Trials (2)
    • Pharmaceutical Innovation (1)
    • Mental Health Treatment (1)
    • Regulatory Affairs (1)
    • Biopharmaceutical (1)
    • Stock Analysis (1)
    • Regulatory Challenges (1)

    🏷️ Keywords

    Compass Pathways (1) · COMP360 (1) · Treatment-resistant depression (1) · Phase III trials (1) · TD Cowen Conference (1) · 25mg dose efficacy (1) · Regulatory approval (1) · Mental health innovation (1) · Aardvark Therapeutics (1) · RBC Capital (1) · ARD-101 (1) · Prader-Willi syndrome (1) · Phase III trial (1) · Stock downgrade (1) · FDA approval (1) · Clinical safety (1)

    📖 Key Information

    The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.

    📰 Related News (2)

    🔗 Entity Intersection Graph

    RBC Capital Markets(1)Food and Drug Administration(1)Regulation(1)Compass Pathways(1)Phases of clinical research

    People and organizations frequently mentioned alongside Phases of clinical research:

    🔗 External Links