📍 Umbrella trial:
- A trial designed to evaluate multiple medical products concurrently for a single disease or condition.
📍 Platform trial:
- A trial designed to evaluate multiple medical products for a disease or condition in an ongoing manner, with medical products entering or leaving the platform.
📍 Basket trial:
- A trial designed to evaluate a medical product for multiple diseases, conditions, or disease subtypes.
“🌏 Master Protocols for Drug and Biological Product Development.’’
https://lnkd.in/gpnbYXGj
🌈 Potential upsides:
Compared with stand-alone trials under separate protocols, a master protocol may offer certain advantages by leveraging:
✅ a shared control arm and other shared protocol elements (e.g., visit schedule, measurement procedures),
✅ shared infrastructure (e.g., network of clinical sites, central facilities, central randomization system, data management systems), and
✅ shared oversight (e.g., steering committee, data review committee).
⚡ Possible challenges:
At the same time, master protocols add elements of complexity, which can increase startup time and lead to design challenges such as ensuring adequate blinding to treatment assignment.
Additionally, master protocols involving multiple stakeholders will require a high degree of coordination.
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