It is very difficult to provide a template for a protocol or a SAP for an adaptive trial as they are very study specific. Instead, we have collated a repository of protocols and SAPs for adaptive trials which can be used as guidance for developing these documents for future trials.
Resource Documents
Protocol:
Hemangiol: A Randomized, Placebo-Controlled, Phase II/III Adaptive Trial
VISIT WEBSITE (the link opens in a new window)Protocol:
Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy (STAMPEDE)
VISIT WEBSITE (the link opens in a new window)Protocol:
The ORVAC Trial: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis
VISIT WEBSITE (the link opens in a new window)Statistical Analysis Plan:
Prone and Oscillation Pediatric Clinical Trial (PROSpect)
VISIT WEBSITE (the link opens in a new window)Statistical Analysis Plan:
ORVAC Trial: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis
VISIT WEBSITE (the link opens in a new window)