20.06.26 Relevant trials

Question 1

What is a phase I trial

Answer 1

• Small trial open to people of all cancer
• Used to determine how much of a drug is safe to give, any side effects, if the treatment works.
• Dose escalation, increase dose slowly in subsequent cohorts and monitor response.

Question 2

What is a phase II trial

Answer 2

• Larger trials open to people with the same type of cancer or different types.
• Used to determine if the treatment works well enough to escalate to a larger trial, which types of cancer the treatment works best for, optimum dose and frequency, how to treat side effects.
• Sometimes randomised and used in parallel with another existing drug or a placebo to compare side effects.

Question 3

What is a phase III trial

Answer 3

• Even larger trial. Numbers have to large enough to identify potentially small changes.
• Often randomised and compare new treatment with best currently available treatment
• Used to determine the effect of treatment on the cancer, how long effect lasts and any long term problems that may develop.