Phase-3 Controlled Clinical Intervention Study

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A Phase-3 Controlled Clinical Intervention Study is a controlled clinical intervention study that assesses an investigational medical intervention's safety and the final evaluation of its efficacy and effectiveness which includes studying its effects on different groups by comparing it to placebo and/or to current approved treatments.

References

2021a

  • (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#P Retrieved: 2022-01-13.
    • QUOTE: Phase II/III trial
      • A trial to study response to a new treatment and the effectiveness of the treatment compared with the standard treatment regimen. (NCI)
    • Phase III clinical trials
      • A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people. (NCI)
      • Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. (NLM)
      • Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase 3 studies usually include from several hundred to several thousand subjects. (21CFR312)

2021b

  • (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Phases_of_clinical_research#Phase_III Retrieved 2022-01-13.
    • QUOTE:This phase is designed to assess the effectiveness of the new intervention and, thereby, its value in clinical practice.[1] Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions. Phase III trials of chronic conditions or diseases often have a short follow-up period for evaluation, relative to the period of time the intervention might be used in practice. This is sometimes called the "pre-marketing phase" because it actually measures consumer response to the drug.

      It is common practice that certain Phase III trials will continue while the regulatory submission is pending at the appropriate regulatory agency. This allows patients to continue to receive possibly lifesaving drugs until the drug can be obtained by purchase. Other reasons for performing trials at this stage include attempts by the sponsor at "label expansion" (to show the drug works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing), to obtain additional safety data, or to support marketing claims for the drug. Studies in this phase are by some companies categorized as "Phase IIIB studies."[2]

      While not required in all cases, it is typically expected that there be at least two successful Phase III trials, demonstrating a drug's safety and efficacy, in order to obtain approval from the appropriate regulatory agencies such as FDA (US), or the EMA (European Union).

      Once a drug has proved satisfactory after Phase III trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life. This collection of information makes up the "regulatory submission" that is provided for review to the appropriate regulatory authorities[3] in different countries. They will review the submission, and if it is acceptable, give the sponsor approval to market the drug.

      Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines through a New Drug Application (NDA) containing all manufacturing, preclinical, and clinical data. In case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market. While most pharmaceutical companies refrain from this practice, it is not abnormal to see many drugs undergoing Phase III clinical trials in the market.[4]

  1. ↑ DeMets D, Friedman L, Furberg C (2010). Fundamentals of Clinical Trials (4th ed.). Springer. ISBN 978-1-4419-1585-6.
  2. ↑ "Guidance for Institutional Review Boards and Clinical Investigators". Food and Drug Administration. 1999-03-16. Retrieved 2007-03-27.
  3. ↑ The regulatory authority in the US is the Food and Drug Administration; in Canada, Health Canada; in the European Union, the European Medicines Agency; and in Japan, the Ministry of Health, Labour and Welfare
  4. ↑ Arcangelo VP, Peterson AM (2005). Pharmacotherapeutics for Advanced Practice: A Practical Approach. Lippincott Williams & Wilkins. ISBN 978-0-7817-5784-3.

2021c

2021d

2018

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