Statistical questions must be refined to effectively evaluate a particular type of clinical study and outcome.

  • What is the proper way to evaluate effectiveness in the target condition and population?
  • What are the unique safety concerns of the device intervention?
  • Is the device as effective or more effective than another intervention?
  • If so, is it as safe or safer?
  • Is the evaluation of safety and effectiveness limited to a particular subgroup of patients?
  • What is the best clinical measure of safety and effectiveness?

One can see that asking these questions will lead not only to a focused study objective, but also will require the sponsor to consider a number of other issues, such as a suitable endpoint or outcome variables, a control population, the type of hypothesis that might be tested and others.

Regulatory Specialists, Inc. can help formulate these issues which must be addressed to design and evaluate a sound clinical trial.