LibraryScenariosWhen to report adverse effects during clinical development
Scenario

When to report adverse effects during clinical development

We discovered our drug has a serious side effect that affects maybe two percent of patients and the regulatory team is debating whether to report it immediately or wait for more data.

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More people experience this than they realize.

What we've seen

You know your drug can hurt some patients, and the company is stalling on telling anyone.

Ideas that help explain it
Worth thinking about

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