Accenture and Phesi Urge Pharma Companies to Use Synthetic Data in Trials
Phesi Inc. and Accenture have released the first of a series of reports exploring the use of synthetic data in clinical development. In recent years, the volume of data created through clinical trials and electronic patient records has increased exponentially, as well as the ability to process and analyze these data. The report outlines several advantages of synthetic data.
The report outlines two cases where use of synthetic data made significant improvements to the trial process: oncology and gastroenterology. In oncology, trials are often extremely costly and time-intensive; a study has recently shown that without a synthetic control arm, the median R&D cost for oncology drugs is $2.77 billion, which is driven by the high failure rate of up to 80%. Recruiting patients in a timely manner is also a challenge in oncology, resulting in a lag in getting treatments to market. The use of synthetic data can help to overcome these challenges by reducing patient numbers and eliminating placebos, helping to speed up the process. In ulcerative colitis, synthetic patient data can be used to synthesize baseline patient characteristics to optimize the protocol design and to again reduce patient numbers and exposure to a comparator.
For more of the report’s findings, click here.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
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