Question 1
This information raises a lot of questions, but you need to prioritise these. What are the two most important things to do first.
Select two options from the answers below.
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A. Incorrect. Repeating a 3-month study will take 6 months to conduct and analyse; given that the findings were observed in two species this is likely to prove fruitless.
B. Incorrect. Conducting studies in other species is relevant only if you can show that the mechanism responsible for the effect is not relevant in humans and your alternative species is a better model for the human situation.
C. Incorrect. Investigative studies could be useful if the development is to proceed, but take time (many months).
D. Incorrect. If the development of your drug is to continue then you may well need to amend your forthcoming protocol; however, you do not have enough information at this stage to make empirical adjustments.
E. Incorrect. If the development of your drug is to continue then you may well need to amend your forthcoming protocol; however, you do not have enough information at this stage to make empirical adjustments.
F. Correct. Protection of patients is paramount. The findings here are potentially serious so you need to suspend your clinical activity until you have more information.
G. Correct. You have a duty to inform regulatory authorities and ethics committees of the findings. You will need to consider whether the findings have implications for patients and volunteers given the drug in completed studies.
H. Incorrect. These are serious findings and may well lead to termination of the project but it is premature to stop all activity until you have all relevant information.
