During the Clinical/Comparative Effectiveness stage, research to investigate the effect of the technology in the target clinical environment is conducted. This may in include observational or experimental study designs, such as randomized clinical trials depending on the technology and the level of regulation that it is subject to. Relevant regulatory bodies as well as healthcare professionals will have requirements for the rigor of testing the technology must undergo in order for it to be marketed or purchased, respectively.
Commercialization Process: Clinical / Comparative Effectiveness
How this Milestone Reduces Project Risk
Evidence to support effectiveness of the technology not only allows it to be put on the market but also increases the likelihood of adoption and reimbursement by payers.
What to consider at this time
What are the key outcomes of interest to the main stakeholders?
Ready to get started?
By completing the Clinical & Comparative Effectiveness Module with TREAT, you will:
- Develop the research questions that must be answered to meet regulatory and marketing requirements.
- Determine the level of rigor of testing necessary for proof of effectiveness to customers.
Use this module guide to understand where Clinical & Comparative Effectiveness fits into your product evaluation strategy.
Introduction to Clinical and Comparative Effectiveness Testing
This presentation will give you an introduction and overview of Clinical & Comparative Effectiveness.