Non-interventional Studies Masterclass

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RCTs (Randomized Controlled Trials) are the Gold Standard for obtaining data on the safety and efficacy of medical therapies in humans - either .. Read more medical products (“drugs”) or medical devices. But RCTs have some limitations – they are time-consuming with lengthy application processes, low case-number and demanding high budgets and many resources. Sophisticated Non-Interventional Studies (NIS) can achieve higher case-numbers, especially in shorter times, needing lower budgets and resources and have to follow less regulatory requirement. In addition, NIS provide Real-World-Data. NIS might also be helpful to obtain information forming hypotheses for new research projects. In addition, NIS are very suitable to collect long-term-data.

Highlights

• Understanding the Need for additional Tools and Methodologies to support Clinical Trials
• Importance of and Need for Real-World-Data
• Distinguish Interventional Studies from Non-Interventional Studies
• Clarification of Terminology - Which Types of NIS (Non-Interventional Studies) exist
• Main Differences between Clinical Trials and NIS