Trial Innovation Center Service
Efficacy to Effectiveness (E2E) is an approach to clinical trial design that addresses the effectiveness and safety gaps that often occur in standard randomized controlled trials. E2E Trials are designed prospectively, whereby an effectiveness trial would commence seamlessly upon completion of the efficacy trial. This approach offers an opportunity for improved understanding of how a treatment will work in more usual real-world clinical settings.
Investigators are invited to apply to the Trial Innovation Center for E2E Consultations, which will take a protocol-specific approach to E2E trial design that focuses on the development of suitable efficacy and effectiveness endpoints, advice on the statistical analysis plan, and the role of the DSMB in moving from the efficacy to the effectiveness phase. Please submit your request for an individual consultation here.
Why should investigators be interested in E2E Design?
- Allows collection of valuable and robust effectiveness and safety data to improve a trial’s impact
- E2E, or seamless designs, are of increasing interest to industry and FDA
- Opportunity for improved understanding of how a treatment works in typical clinical settings
- Evidence-based approach to inform clinical decisions and policy
- Potential wider population or market for intervention
Read more about E2E Design here: A Proposal for Integrated Efficacy-to-Effectiveness (E2E) Clinical Trials, and a commentary by Rob Califf.
Submit Applications Now to participate in the 2-day E2E Design Lab in March 2018 – more information here
Trial Innovation Network Proposal Process Toolbox
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