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International Clinical Trials

The Progress of Real-World Data and Artificial Intelligence

Life science companies are increasingly investing in real-world data (RWD) and exploring advanced technologies, such as artificial intelligence (AI) to help improve throughput. There are some early and encouraging signs that RWD and AI can help companies transform study design, trial operations, and patient care by improving efficiency, lowering costs, and identifying patterns, with the goal of improving outcomes for patients. However, broad adoption of AI-based solutions remains challenged by data sharing and data privacy issues. Limited collaboration across companies and sectors can also impede the adoption of innovative approaches. The life science industry must address these areas to recognise the potential of AI.

Helping to Accelerate Clinical Trials and Improve Quality

Uninformed clinical trial protocols can result in costly amendments and limit patient participation. Consider that about 67% of protocols have at least one amendment, and nearly half of these amendments are avoidable. The median cost to implement an amendment could reach $535,000 for a Phase III protocol (1). Patient populations that fail to approximate the real world may also limit access to new medicines and diminish their value (2). Life science companies and health authorities are recognising the untapped potential of RWD – a rapidly expanding source of digital health information – to help inform clinical trial study design and protocol development. Additionally, continuous monitoring through mobile devices and sensors are enabling novel endpoint development. As the technology begins to mature, we start to better understand its value and utility.

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Rob DiCicco, Deputy Chief Health Officer, joined IBM after a long career in Pharmaceutical R&D spanning nearly 30 years; 25 with GlaxoSmithKline, where he served in a variety of leadership positions. While at GSK, Rob was the Vice President of Clinical Pharmacology Sciences and Study Operations, with a global footprint that included the US, UK, Australia, and China. He also led the development of a number of late phase oncology projects leading to successful product approvals. Rob received his Doctor of Pharmacy Degree from the University of the Sciences in Philadelphia, US. His areas of expertise and interest include clinical trial design, clinical operations, protocol quality, and ethics in research.

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