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AI digital twins could replace control arm in clinical trials

Drug Discovery World

A new study demonstrates that AI-powered digital twin solutions can potentially replace the standard-of-care (SOC) control arm of a clinical trial. The paper was co-authored by analytics company Phesi and Dr Yi-Bin Chen, Director for the Blood and Marrow Transplant Program at Massachusetts General Hospital.

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New clinical trial facility opens in Liverpool

Drug Discovery World

The new Liverpool Clinical Research Facility (CRF) unit has opened at the new Royal Liverpool University Hospital thanks to £5.3m ($6.4m) funding from the National Institute for Health Research (NIHR). This design means the unit can conduct Phase I human trials.

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First UK patients receive experimental mRNA therapy for cancer

Drug Discovery World

The first UK patients have received an mRNA cancer therapy – mRNA-4359 – as part of a Phase I/II clinical trial investigating its potential for treating melanoma, lung cancer and other solid tumour cancers. The trial is sponsored by Moderna through the Moderna-UK Strategic Partnership.

Therapies 278
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From data to cure: The journey of AI in cancer trials

Drug Discovery World

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. MIT research 4 tells us a hard truth: about 95% of these trials fall short, leaving behind a trail of broken hopes for cancer patients each year.

Trials 147
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Encouraging results for RESP-X in ongoing Phase I clinical trial

Drug Discovery World

RESP-X, Infex Therapeutics’ anti-virulence therapy to treat Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB) patients, has shown a promising interim safety and tolerability profile in its ongoing first-in-human Phase I clinical trial.

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GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program

FDA Law Blog: Biosimilars

According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards. In other words, the inspectional output was inversely proportional to the importance of clinical research.

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GxP Best Practices for Safer, Smarter, Faster Clinical Research

Advarra

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.