Are you familiar with what 'expanded access' means?

How to Answer
1st Answer Example
2nd Answer Example

Expanded access is the term used to describe the means by which manufacturers make new drugs that are being investigated available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial. If you have experience working with patients who have been given expanded access, share some details, as appropriate. If you don't have personal experience, share your knowledge.

"It is my understanding that 'expanded access' is granted, under certain circumstances, to patients who do not qualify to participate in a clinical trial of a regulatory drug. The drug used in expanded access cannot expose patients to unreasonable risks given the severity of the disease to be treated and the patient must not have any other satisfactory therapeutic options."

"I do have some knowledge about 'expanded access' although I have not worked directly with patients who have been giveThe manufacturer must be willing to make the drug available for expanded access use. The primary intent of expanded access is to provide treatment for a patient's disease or condition, rather than to collect data about the study drug."

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How to Answer: Are you familiar with what 'expanded access' means?

Advice and answer examples written specifically for a Contract Research Organization job interview.

2. Are you familiar with what 'expanded access' means?

How to Answer

Expanded access is the term used to describe the means by which manufacturers make new drugs that are being investigated available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial. If you have experience working with patients who have been given expanded access, share some details, as appropriate. If you don't have personal experience, share your knowledge.

1st Answer Example

"It is my understanding that 'expanded access' is granted, under certain circumstances, to patients who do not qualify to participate in a clinical trial of a regulatory drug. The drug used in expanded access cannot expose patients to unreasonable risks given the severity of the disease to be treated and the patient must not have any other satisfactory therapeutic options."

2nd Answer Example

"I do have some knowledge about 'expanded access' although I have not worked directly with patients who have been giveThe manufacturer must be willing to make the drug available for expanded access use. The primary intent of expanded access is to provide treatment for a patient's disease or condition, rather than to collect data about the study drug."

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