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Monday, Nov 20th

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Home Cancer Cancer Topics What is a Clinical Trial?

What is a Clinical Trial?

Phase III
Clinical Trials - Phase III
  • From 100 to thousands of people.
  • Equal chance to be assigned to one of two or more groups.
  • Determines
    • How the new treatment compares with the current standard.
    • Or how it compares with placebo.

Clinical trial IVClinical trial IV
Phase IV
  • From hundreds to thousands of people.
  • Usually takes place after drug is approved to provide additional information on the drug’s risks, benefits and optimal use.

Randomised Clinical Trials
  • Equal chance to be assigned to one of two or more groups.
    • One gets the most widely accepted treatment (standard treatment).
    • The other gets the new treatment being tested, which researchers hope and have reason to believe will be better than standard treatment.
  • All groups are as alike as possible.
  • Provides the best way to prove the effectiveness of a new agent or intervention.
Randomisation

Randomisation

Open versus Blinded Clinical Trials.
  • Open Label clinical trials.
    • The doctor and patient know which drug or vaccine is being administered.
  • Blinded clinical trial.
    • Single Blind: the patient doesn’t know which treatment he/she is getting.
    • Double Blind: neither doctor nor patient knows.
Placebo Control
  • The new treatment is tested against an inactive (or dummy) treatment that looks the same.
Pilot Study
  • A small study that helps develop a bigger study.
  • A first foray into a particular area.
  • Used to iron out possible difficulties, and help with design of the bigger, more pivotal study.
Treatment Trials
  • Involve people who have cancer.
  • Test new treatments, new combinations of drugs or new approaches to surgery or radiotherapy.
  • Determine the most effective treatment for people who have cancer.
  • Test safety and effectiveness of new agents or interventions in people with cancer.
Prevention Trials
  • Evaluate the effectiveness of ways to reduce the risk of cancer or prevent the recurrence of cancer
  • Enroll healthy people at high risk for developing cancer.
  • Assess new means of detecting cancer earlier in healthy people.


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