Synthetic and external control arms
Are you designing a single arm trial in oncology or rare diseases? A synthetic control arm could give you the additional evidence you need to support regulatory submission.
The increase in single arm trials in oncology and rare diseases has created challenges when it comes to comparing treatments. In response, the use of synthetic and external control arms has grown dramatically, enabled by improved access to data including statistical toolkits from many research fields. But are they the answer and what benefits do they bring?
We can give you the insights for regulatory success
Though synthetic controls in general are supported by regulators, the majority still fail to meet the criteria for clinical benefit. At Cytel we have 30 years’ experience of taking therapies from conception to commercialisation. We are experts at data sourcing, matching and processing to optimise synthetic control trial design and provide the valuable insights you need for success. Today we are one of the few companies with regulatory success in getting such applications approved in the market.