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In Brief
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ICH GCP Annex 2 will strengthen sponsor confidence in the use of DCTs and RWD

Sponsors have increasingly adopted new clinical trial models, including decentralised trials and real-world data, but global regulatory harmonisation has been lacking.

Latest news

AstraZeneca axes NSCLC trial after bispecific deemed unlikely to best Keytruda

While it discontinued the Phase III trial, AstraZeneca did announce two NSCLC successes with other oncology assets.

FDA approves ArkBio’s ziresovir for Phase II trial in severe RSV

Ziresovir is said to be the first direct-acting RSV antiviral to complete a Phase III clinical trial with positive results.

Fate Therapeutics begins Phase II trial of FT819 for lupus nephritis

The trial will enrol around 53 participants and aims to complete enrolment in 15 to 18 months.

Barriers stopping US biotechs from running FIH trials on home soil

The survey data comes shortly after the US Government announced Operation Trialblazer to boost Phase I research in the US.

AI can deliver gains of $21m per drug development programme, study finds

AI is being adopted more in the clinical trial workflow as sponsors realise its potential for accelerating drug development.