Given the high failure rates and the increased costs of clinical trials, researchers need innovative design strategies to best optimize financial resources and reduce the risk to patients.
Adaptive designs are emerging as a way to reduce risk and cost associated with clinical trials. The FDA recently published new draft guidance on adaptive trials and are actively encouraging sponsors to use Adaptive trials.
Adaptive trials are a type of clinical trial design that allows adaptations or modifications to aspects of the trial while it is on-going, without undermining the validity and integrity of the trial. One common adaption is a sample size re-estimation, which increases the sample size in response to interim data.
In this webinar, Ronan will demonstrate nQuery's new Adaptive module focusing on Sample Size Re-estimation, including unblinded sample size re-estimation based on interim "promising" results.
Speaker: Ronan Fitzpatrick, Head of Statistics, Statsols
Duration: 60 minutes
About Our Host
Ronan Fitzpatrick is Head of Statistics at Statsols and the Lead Researcher for nQuery Sample Size Software. He is a guest lecturer for many institutions including the FDA.