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Hematology, oncology > Study design/research > Flashcards

Flashcards in Study design/research Deck (5)
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1
Q

Phase I study objective + design

A
  • Assess the safety of a drug or device. Determine the highest dose that can be given without causing severe SE’s.
  • First few people get a very low dose of treatment and are closely watched. If there are only minor SE’s, next few participants get a higher dose.
  • Include a small number of people (up to a few dozen).
  • Typically done in major cancer centers
2
Q

basket trial concept

A

a method of conducting clinical studies in which patients can enroll based on the mutations in their tumors

3
Q

Phase II study objective + design

A
  • Test the efficacy of a drug.
  • Group of 25 to 100 patients with the same type of cancer get the new treatment using the dose found to be safest in phase I studies
  • Typically everyone gets the same doses, but some phase II studies randomly assign people to different treatment groups
  • No placebos
4
Q

Phase III study objective + design

A
  • Objective: Is it better than what’s already available?

- Randomized and blind testing in several hundred to several thousand patients.

5
Q

Definition of disease free survival

A

Length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

Decks in Hematology, oncology Class (218):