পদ্ধতির তুলনা করুন
নির্বাচিত পদ্ধতিগুলো পাশাপাশি পর্যালোচনা করুন; যে সারিগুলোয় পার্থক্য আছে সেগুলো চিহ্নিত করা হয়।
| পর্যায় III ক্লিনিক্যাল ট্রায়াল× | Adaptive Randomized Clinical Trial× | |
|---|---|---|
| ক্ষেত্র | মহামারীবিদ্যা | মহামারীবিদ্যা |
| পরিবার | Process / pipeline | Process / pipeline |
| উদ্ভবের বছর≠ | 1962 (Kefauver-Harris Amendment formalised phased drug development) | Late 1990s–2000s (widespread adoption post-2010) |
| প্রবর্তক≠ | FDA regulatory framework / ICH guidelines | Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019 |
| ধরন≠ | Confirmatory randomised controlled trial | Experimental clinical trial design |
| মৌলিক উৎস≠ | Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385 | Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗ |
| অপর নাম | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT | adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial |
| সম্পর্কিত | 6 | 6 |
| সারসংক্ষেপ≠ | A Phase III clinical trial is a large-scale, confirmatory randomised controlled trial designed to establish the efficacy and safety of an intervention in the target patient population before regulatory submission. It builds on the signal identified in Phase II, tests the intervention at its proposed dose under controlled conditions, and provides the primary evidence base for marketing authorisation or guideline adoption. | An adaptive randomized clinical trial (adaptive RCT) is a prospective experimental study that uses pre-specified rules to modify one or more trial aspects — such as sample size, allocation ratios, or treatment arms — based on accumulating data collected during the trial itself, while maintaining statistical validity and integrity of the study. |
| ScholarGateডেটাসেট ↗ |
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