To help navigate the specific challenges of Medical Device Clinical Trials we thought we would share some general observations gleaned from our extensive involvement as trial statisticians in medical device trial design and analysis. Not all devices require trials, and, for those that do, the regulations determine what type of trial is needed. Advice from regulatory experts should be sought on this issue.

This series of blogs will explore the biomathematical considerations important for the design, tendering, execution, analysis and reporting of all types of device clinical trials, from the simplest non interventional study to complex adaptive trials of highly interventional products.

Implications for developers

There are many similarities between conventional pharmaceutical and Medical Device clinical trials with regards to trial design, conduct and analysis, but there are also many nuances that require careful biomathematical considerations in design and execution.

In this series we will also be covering the following key areas:

1. Clinical trial design considerations (Planning)
   • The pathway
   • Non- inferiority, superiority, “registry” trials
   • Aims, objectives, and endpoints
2. Clinical trial design considerations (Execution)
   • Sample size
   • Control groups and blinding
   • Randomisation
3. Clinical trial design issues

• • Influence of rapidly changing technology

4. Tendering
   • What drives analysis costs
   • Tips for achieving useful tender responses (for the analysis portion)