CLINICAL TRIAL DESIGN, IMPLEMENTATION, AND ANALYSIS

Name: CLINICAL TRIAL DESIGN, IMPLEMENTATION, AND ANALYSIS
Availability: OutOfStock

BMI/STAT 643

과목 설명

Gain an understanding of fundamental elements of clinical trials (such as objectives, endpoints, surrogate endpoints, and statistical decisions) and statistical design considerations (such as randomization and blinding). Designs of clinical trials for Phase I, II, and III studies including single-arm, two-arm, and drug combination trials. Introduction to adaptive designs for precision medicine and master protocol designs such as umbrella trials and basket trials.

선수과목

STAT 609 , STAT 610 , BMI/STAT 641 , or graduate/professional standing

충족 요건

This course does not satisfy any prerequisites.

학점

미보고

개설 시기

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평점

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변화 계산 불가

수료율

미보고

변화 계산 불가

A 비율

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변화 계산 불가

학급 규모

미보고

과거 데이터 대비 변화 없음

Cumulative Grade Distribution

강사 (2026 Summr)

다음 사이트의 평점순으로 정렬 Rate My Professors

유사 과목

INTRODUCTION TO BIOSTATISTICS

BMI/STAT 541

Course designed for the biomedical researcher. Topics include: descriptive statistics, hypothesis testing, estimation, confidence intervals, t-tests, chi-squared tests, analysis of variance, linear regression, correlation, nonparametric tests, survival analysis and odds ratio. Biomedical applications used for each topic.

STATISTICAL METHODS FOR EPIDEMIOLOGY

BMI/STAT 642

Methods for analysis of case-control, cross sectional, and cohort studies. Covers epidemiologic study design, measures of association, rates, classical contingency table methods, and logistic and Poisson regression.

STATISTICAL METHODS FOR CLINICAL TRIALS

BMI/STAT 641

Statistical issues in the design of clinical trials, basic survival analysis, data collection and sequential monitoring.

INTRODUCTION TO CLINICAL AND HEALTHCARE RESEARCH II

BMI 544

Practical training and skills required in clinical and healthcare research; design, implementation, and conduct of clinical trials and health services research studies; protocol and informed consent development using protocol templates; regulatory requirements; human subjects research protections considerations; data and safety monitoring plans; data collection strategies and data management; strategies to recruit/retain diverse and equitable study participants; research study agreements; budget development and justification; federal, institutional, and sponsor-defined requirements; establishment of research infrastructures for participant safety and study success; preparation of investigator-INDs/IDEs; and investigator responsibilities.

INTRODUCTION TO CLINICAL TRIALS I

BMI/STAT 542

Intended for biomedical researchers interested in the design and analysis of clinical trials. Topics include definition of hypotheses, measures of effectiveness, sample size, randomization, data collection and monitoring, and issues in statistical analysis.