Decentralized clinical trials (DCTs) hold the promise to reduce site and patient burdens and enhance the experience of participating in drug development by offering a more patient-focused approach.
In traditional studies, site study startup takes on average 6 - 8 months to complete according to the Tufts Center for the Study of Drug Development (CSDD) – and this timeline is getting longer – this is unsustainable. DCTs have forced the industry to rethink their approach to study startup and associated regulations.
ICH E6 (R1) led to regulatory driven “one size fits all” SOPs for study design and startup in traditional trials. Forthcoming, ICH E6 (R3) provides stakeholders tools to move from the customary habits of fixed checklists to a fit-for-purpose approach. These can be implemented now, allowing for proactive planning and ultimately greater adoption of innovative trial designs.
Key Learning Objectives:
- Why the current interpretation of clinical regulations has hindered a smooth adoption of innovation trial designs (e.g., DCTs, hybrid, etc.)?
- When in the clinical development process can and should a study design decision on DCT be made?
- When should risk identification and assessment be done?
- What impact does a DCT have on site selection and activation practices?
- How innovative trial designs can be offered at scale now.
Who Should Attend:
- Sponsor and CRO roles who are responsible for:
- Clinical development planning
- Study designs
- Country and site identification, feasibility assessment, selection, and activation
- Clinical data management, collecting and evaluating trial metrics
- Project management of studies, process optimization, and operational excellence
To learn more about Oracle Health Sciences, visit their Clinical Leader page.