পদ্ধতির তুলনা করুন
নির্বাচিত পদ্ধতিগুলো পাশাপাশি পর্যালোচনা করুন; যে সারিগুলোয় পার্থক্য আছে সেগুলো চিহ্নিত করা হয়।
| প্রথম-মানব-পরীক্ষা (First-in-Human) মাত্রা-বৃদ্ধি বিষয়ক গবেষণা× | র্যান্ডমাইজড ক্লিনিক্যাল ট্রায়াল (RCT)× | |
|---|---|---|
| ক্ষেত্র | মহামারীবিদ্যা | মহামারীবিদ্যা |
| পরিবার | Process / pipeline | Process / pipeline |
| উদ্ভবের বছর≠ | 1960s (formal regulatory framework established ~1963–1970s) | 1948 (first rigorously conducted RCT — MRC streptomycin trial) |
| প্রবর্তক≠ | Regulatory and clinical pharmacology community; formalized in U.S. FDA IND regulations (1963) and ICH guidelines | Austin Bradford Hill; MRC Streptomycin Trial team |
| ধরন≠ | Interventional clinical study design | Interventional experimental study |
| মৌলিক উৎস≠ | Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937. DOI ↗ | 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 |
| অপর নাম | Phase 1 trial, first-in-human study, FIH study, dose-escalation study | RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial |
| সম্পর্কিত | 6 | 6 |
| সারসংক্ষেপ≠ | A Phase I clinical trial is the first stage of human testing for a new drug, biologic, or intervention. Its primary objective is to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) rather than therapeutic efficacy. Small cohorts of participants — typically healthy volunteers or patients with advanced disease — receive sequentially increasing doses to identify the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) that define the boundary for subsequent trials. | A randomized clinical trial (RCT) is an experimental study design in which participants are randomly assigned to an intervention group or a control group, then followed prospectively to compare outcomes. Random allocation is the defining feature: it distributes known and unknown confounders across groups by chance, making the RCT the strongest individual study design for establishing causal efficacy of a treatment or intervention under controlled conditions. |
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