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Plaintiffs, including several well-known community figures, claim BDs EtO emissions exposed thousands to unsafe levels of the carcinogenic gas, resulting in diagnoses of breast cancer, lymphoma, and leukemia

These include high doses, long-term use, and coexisting mental health conditions

The regulatory acceptance of ePRO data in primary endpoint positions has expanded substantially, and ePRO-collected data now supports pivotal submissions in oncology, neurology, cardiology, rare disease, and mental health indications at the FDA, EMA, and PMDA. Signant Health's SmartSignals eCOA and Medidata's Patient Cloud represent the leading commercial ePRO deployment environments, each offering configurable instrument libraries covering validated scales including PROMIS, EQ-5D, FACT-G, and MADRS alongside custom instrument design tools for protocol-specific endpoints

doi: 10.1007/s10787-019-00608-2 129 WangYChenJLuoXZhangYSiMWuHet al