A new report from Phesi and Accenture is encouraging pharmaceutical companies to utilise synthetic data in clinical trials.
Synthetic data is based on real-world data sets, used to accurately predict the ‘synthetic patient profile’ and deploy a virtual cohort in a clinical trial.
The report is the first in a series exploring the use of synthetic data in clinical development. It outlines two cases where synthetic data was used within the clinical trial process – in oncology and gastroenterology.
In oncology, trials can be costly and time-intensive – in a study without a synthetic control arm, the median R&D cost for oncology drugs is $2.77bn.
In addition, recruiting patients can also be a challenge in oncology, meaning it often takes longer to get treatments to market.
The report details how synthetic data could help to overcome some of these challenges, by reducing patient numbers and eliminating placebos to accelerate the process.
In addition, the report found that in ulcerative colitis, synthetic patient data could be used to synthesise baseline patient characteristics to ‘optimise’ protocol design.
This could also reduce patient numbers and exposure to a comparator, according to the report authors.
“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,” said Boris Bogdan, managing director, Accenture.
“Synthetic patient data minimises the need for placebos and accelerates the development process,” he added.