Volume : 13, Issue : 08, August – 2026
Title:
RECENT ADVANCES IN BIOSTATISTICAL METHODS FOR CLINICAL RESEARCH: ADAPTIVE DESIGNS, BAYESIAN INFERENCE, AND REAL-WORLD EVIDENCE
Authors :
Payal Patidar, Soma Sekhar Pulamarasetti*, Omkar Rai, Karan Gupta, Shivlal Yadav
Abstract :
Background: The standard fixed-sample randomized clinical trial is often difficult to implement operationally and ethically in heterogeneous patient populations, rare disease indications, and rapidly evolving therapeutic landscapes. Recent methodologies have been developed for adaptive trial designs, Bayesian inferential frameworks and real-world evidence (RWE) to increase trial efficiency, sample allocation and decision certainty1.
Objective: To review progress in biostatistical methods for confirmatory adaptive designs, Bayesian computation and information borrowing, master protocol architectures, and causal inference frameworks for integration of real-world data1.Data Sources: Methodological literature, regulatory guidance documents, and applied trial reports indexed in PubMed, MEDLINE, Scopus, and regulatory archives from 2014 to 20261.
Review Methods: Narrative synthesis of theoretical frameworks, mathematical formulations and operating characteristics and translational applications across adaptive designs, Bayesian modeling and target trial emulation1.
Key findings: Adaptive designs such as sample size re-estimation, seamless phase II/III, and response-adaptive randomization (RAR) improve the use of resources but require strict prospective planning and type I error control via combination tests or conditional error functions1. Bayesian methods, with explicit uncertainty quantification and dynamic historical borrowing via robust meta-analytic-predictive (rMAP) priors, mitigate prior-data conflicts in data-sparse settings2. Master protocols (basket, umbrella and platform trials) are built on centralized infrastructures and Bayesian decision algorithms to evaluate candidate therapies in parallel13. Target trial emulation provides a causal framework to link observational analysis to experimental standards, including how to handle immortal time bias and confounding by indication in regulatory submissions3.
Conclusion: Modern clinical research is increasingly characterized by hybrid biostatistical designs that integrate adaptive protocols with Bayesian modeling and real-world data borrowing2. Regulatory acceptance and clinical validity require simulation-based optimization of operating characteristics, transparent reporting, and procedural firewalls to preserve trial integrity5.
Keywords: Biostatistics, Adaptive Trial Designs, Bayesian Inference, Real-World Evidence, Clinical Research
Cite This Article:
Please cite this article in press Soma Sekhar Pet al., Recent Advances In Biostatistical Methods For Clinical Research: Adaptive Designs, Bayesian Inference, And Real-World Evidence. Indo Am. J. P. Sci, 2026; 13(08).
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Volume : 13, Issue : 08, August – 2026
Title:
EVALUATION OF ANTIHYPERLIPIDEMIC ACTIVITY OF SAPINDUS EMARGINATUS IN RATS
Authors :
Chinthala Jamima*, Dr.R.narasimha Rao, Dr.N. Raghunandhan
Abstract :
Obesity and hyperlipidemia have become major disorders predominantly causing prevailing cardiovascular diseases and ultimately death. The prolonged use of anti-obesity drugs and statins for reducing obesity and blood lipid levels is leading toward adverse effects of kidneys and muscles, specifically rhabdomyolysis. The objective of this study is to evaluate potential of seeds of Sapindus emarginatus against hyperlipidemia. In this model of Hyperlipidemia, 30 adult male wistar rats (200-250gms) were evenly divided into 5 groups in both groups. Group-1 and Group-2 served as untreated and model controls respectively, while Group-3, 4 and 5 were the treatments groups which were simultaneously treated with standard, 100 and 200 mg/kg extract respectively along with High Fat Diet. On last day, blood samples for biochemical parameters, were obtained under inhaled diether anaesthesia. The outcomes of this study were expressed as mean standard error and data were evaluated by using analysis of variance followed by multiple comparisons. Oral administration of 100 mg/ kg and 200mg/kg body weight of Methanolic extract residual fraction of Moringa oleifera. Leaves exhibited a significant reduction (P < 0.01) in serum lipid parameters such as triglycerides, total cholesterol, low density lipoprotein (LDL), very LDL and increase in high density lipoprotein in hyperlipidemic rats when compared with hyperlipidemic control in both models. Our results demonstrated that Methanolic extract fraction of Sesbania grandiflora. Possessed significant antihyperlipidemic activity.
Keywords: Sesbania grandiflora, Cholesterol, LDL, triglycerides and antihyperlipidemic activity.
Cite This Article:
Please cite this article in press Chinthala Jamimaet al., Evaluation of Antihyperlipidemic activity of Sapindus Emarginatus in rats,, Indo Am. J. P. Sci, 2026; 13(08).
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