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Phase of clinical trial with the highest rate of drug failure

A) Phase I
B) Phase II
C) Phase III
D) Phase IV

1 Answer

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Final Answer:

Phase III of clinical trials typically experiences the highest rate of drug failure. Therefore, the correct option is C) Phase III.

Step-by-step explanation:

Phase I trials primarily focus on assessing safety and dosage, often involving a small number of healthy volunteers. While failures can occur due to safety concerns or inadequate efficacy data, Phase I trials tend to filter out highly unsafe compounds early in the process.

Phase II trials involve a larger group of participants to further evaluate safety and start assessing effectiveness. Failure rates in Phase II trials can be significant due to insufficient efficacy or unforeseen safety issues that weren't evident in the smaller Phase I cohort.

However, Phase III trials, involving large patient populations, have the highest rate of failure. These trials aim to confirm efficacy, monitor side effects, and compare the drug to existing treatments or placebos rigorously. Failures at this stage often result from the drug's inability to demonstrate superior efficacy compared to standard treatments or due to unexpected safety issues emerging in the larger, more diverse population.

Phase IV trials occur after a drug has been approved for use, focusing on post-market surveillance. While Phase IV may uncover new safety concerns, it typically has a lower failure rate as the drug has already passed through rigorous testing in earlier phases. Therefore, the correct option is C) Phase III.

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