Question 1
What type of study is likely to be most informative at this stage?
Select one option from the answers below.
What type of study is likely to be most informative at this stage?
Select one option from the answers below.
A. Incorrect. At the moment you do not have sufficient information about the dose-response relationship for this drug. To progress to phase III without this information would be costly and have a high risk of failure.
B. Incorrect. A long-term safety study would be of interest but in 30 subjects for 6 months it would yield relatively little information.
C. Correct. The early information suggests that low doses of the drug have bronchodilator effects. Further progress will require a careful investigation of the dose-response curve to inform the dose used in confirmatory Phase III studies.
D. Incorrect. A placebo-controlled trial is unlikely to be appropriate when there are existing therapies available.
