Phesi Inc., a data-driven provider of AI-powered clinical development analytics products and solutions, and Accenture, a global services and consulting company with leading capabilities in digital, cloud, and security, 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. Such advances mean that life science companies can now take advantage of real-world data sets, accurately predict the ‘synthetic patient profile’, and deploy a virtual cohort in a clinical trial. The report outlines several advantages of synthetic data; it substantially reduces the number of patients required to be recruited, reduces the patient burden by minimizing the need for placebo treatments and comparator arms, reduces costs, and helps to increase the pace of getting drugs to market.
“Clinical trials are a known cost-center in clinical development. For many years, sponsors and regulators have sought new approaches that reduce expenditure and shorten times, and most importantly, accelerate the delivery of new therapies to patients. Synthetic data offers many such advantages, and it reduces the ethically questionable use of placebos in clinical trials,” said Dr Gen Li, Founder and President, Phesi. “To realize the many benefits of synthetic data in trials, large volumes of data are required. Biopharmaceutical companies typically only have access to their own data which is not enough for rigorous analysis. Sponsors must seek to partner with both data and analytics providers to close this gap. This is a critical area for the future of clinical trials, and we are pleased to publish this report with Accenture to build awareness of the potential 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.
“It is important to limit the burden on patients participating in a clinical trial. Many avoid clinical trials altogether as worries over receiving a placebo treatment dissuade them,” commented Dr Boris Bogdan, Managing Director, Accenture. “Synthetic patient data minimizes the need for placebos and accelerates the development process. At Accenture, we are dedicated to helping companies deliver better patient outcomes through differentiated approaches – and we see synthetic data as a key element. Working with Phesi on this report has underlined how clinical development would greatly benefit from adopting a data led approach in future trials.”
The full report, Faster and Cheaper Clinical Trials: The Benefit of Synthetic Data, can be accessed and downloaded for free at: https://bit.ly/faster-cheaper-clinical-trials
