The initiative aims to speed up the approval of medicines, reduce the administrative burden and boost competitiveness against China

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The US Food and Drug Administration (FDA) has launched an innovative pilot programme to monitor clinical trial data in real time, with the aim of significantly speeding up the approval of new medicines and boosting international competitiveness.

The initiative seeks to reduce so-called ‘downtime’ in pharmaceutical development, which, according to Commissioner Marty Makary, can account for up to 45% of the process due to administrative tasks. With this new approach, the agency will be able to access key trial signals directly, such as adverse effects or response rates, without relying on comprehensive reports produced by companies.

Unlike other models, the system does not involve accessing individual medical records, which helps to protect patient privacy. Instead, it will work with aggregated data that allows regulators to make faster decisions without compromising safety.

The programme will use aggregated data to enable regulators to make decisions more quickly

According to Reuters, the programme is already in the trial phase with companies such as AstraZeneca, via Paradigm Health, and Amgen, which are participating in clinical trials at various stages. Furthermore, companies such as Johnson & Johnson are already incorporating artificial intelligence to streamline regulatory processes.

The FDA has launched a public consultation to refine the programme’s design, with a view to expanding it in the near future, in a move aimed at transforming the way medicines are assessed and approved.