Medical Devices

Artificial intelligence/machine learning (AI/ML) advances that allow clinical trial sponsors to create synthetic control arms (SCAs) -- instead of enrolling patients on active comparators – are expected to provide better quality data for drug development “go”/“no-go” decisions, experts said. SCAs will also allow sponsors to generate investor confidence in early-phase assets, they said.

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US REGROW Act has chance of passing postpresidential election, risks cell therapy business paradigm, patient safety – experts

The proposed US REGROW bill that has elicited concern from many cell therapy developers is unlikely to pass in Congress’s current session, but has success potential postelection, said political consultants. Cell therapy experts said despite the REGROW bill’s well-meaning aim of faster patient access to therapies, if passed it will harm development across the cell therapy industry and risk patient safety.

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Digital monitoring devices threaten traditional CRO services but offer opportunities for 'big data' statisticians - experts

The shift towards using remote monitoring digital devices in clinical trials could threaten traditional CRO service offerings, experts said. But while site monitoring work is set to drop, there may be an outsourcing opportunity for companies offering statistical services for analysing the large volumes of patient data generated by wearable sensors, they said. However, operational and regulatory hurdles must be overcome before remote monitoring can be widely adopted in trials, they added.

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