Study Design

Biostatistics for Medical Product Regulation

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Source: Johns Hopkins Bloomberg School of Public Health

Type: PowerPoint & Lecture Materials

Level: Introductory

Description: Provides a broad understanding of the application of biostatistics in a regulatory context. Reviews the relevant regulations and guidance documents. Includes topics such as basic study design, target population, comparison groups, and endpoints. Addresses analysis issues with emphasis on the regulatory aspects, including issues of missing data and informative censoring. Discusses safety monitoring, interim analysis and early termination of trials with a focus on regulatory implications.



Biostatistical Methodology in Clinical Trials

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Source: ClinDescience Consultancy for Drug and Clinical Development

Type: Article

Level: Introductory

Discription: This article reviews types of clinical trials and sampling strategies.



Statistics for Psychosocial Research: Structural Models

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Source: Johns Hopkins Bloomberg School of Public Health

Type: PowerPoint / Lecture Materials

Level: Advanced

Description: Quantitative study on principles of path analysis, casual inference, measurement models, and other relevant topics to social sciences.



Health Equity: Progress and Pitfalls

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Souce: University of North Carolina Gillings School of Global Public Health Minority Health Project

Type: Webinar

Level: Intermediate

Discription: Overview of procedures and historical progress



Decision Modeling Cost-Effectiveness

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Source: Tufts Clinical and Translational Science Institute

Type: Online Course

Level: Advanced

Description: “After completing this lecture, you will be able to:
Show how the probability of a diagnosis is affected by a test result, sensitivity, and specificity
Describe how evidence can be integrated using decision trees
Illustrate the concept of threshold probabilities and their implications
Discuss how sensitivity analyses are performed and what they mean
Explain how patient preferences (utilities or values) can be integrated into patient-centered choices using decision analysis
Identify different types of economic analyses in comparative effectiveness research
Explain how to calculate incremental cost-effectiveness
List how cost-effectiveness analysis is being used for technology assessment”



Systematic Review and Meta-Analysis

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Source: Tufts Clinical and Translational Science Institute

Type: Online Course

Level: Intermediate

Description: “After completing this lecture, you will be able to:
List the reasons for conducting systematic reviews
Appreciate the role of systematic review in CER
Describe the components of a systematic review
State the role of analytic frameworks in systematic review and the approach to formulate answerable systematic review questions
Identify the users and producers of systematic reviews
Define the basic principles of combining data
Identify the common metrics for meta-analysis
List the basics of combining results across studies and effects of weights
Explain the meaning of heterogeneity
Discuss the fixed effect and random effects model
Interpret meta-analysis results”



Retrospective and Observational Comparative Effectiveness Studies

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Source: Tufts Clinical and Translational Science Institute

Type: Online Course

Level: Intermediate

Description: “After completing this lecture, you will be able to:
State the limitations of randomized controlled trials
Identify the settings in which observational studies of comparative effectiveness may be particularly helpful to clinicians and policymakers
Explain the methodological challenges in conducting retrospective, observational CER using existing sources of data
Describe model-based and other approaches to reduce the effects of confounding in observational CER
Discuss specific examples of retrospective and observational CER, and how these have informed public policy and healthcare delivery system change
List key aspects and the steps of a systematic review
Identify the methodological and inferential challenges of longitudinal observational studies of health outcomes and delivery system change”



Personalized Medicine, Heterogeneity of Treatment Effect, and Implications for Comparative Effectiveness

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Source: Tufts Clinical and Translational Science Institute

Type: Online Course

Level: Advanced

Description: “After completing this lecture, you will be able to:
Identify the limitations of applying the overall results of clinical trials to individual patients
Discuss how summary results of individual trials might not even reflect the benefits of typical patients in the trial
Explain how subgroup analyses are prone both to false-positive and false-negative results
Illustrate approaches that might lead to more credible and actionable subgroup results
Express why multidimensional risk models may have advantages over conventional “one-variable-at-a-time” subgroup analysis
Determine some of the limitations of using genetic information as a basis for exploring heterogeneity of treatment effect”



Considerations of Research Design

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Source: Office for Human Research Protections (OHRP) Archive
Type: Website

Level: Basic

Description: Detailed analysis of structures and stages of research. Topics discussed include implementation and incremental study.

Continuing Education Credits: N/A



Statistical Reasoning 2

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Source: Johns Hopkins Bloomberg School of Public Health

Type: PowerPoint & Lecture Materials

Level: Intermediate

Description: Statistical Reasoning in Public Health II provides a broad overview of biostatistical methods and concepts used in the public health sciences, emphasizing interpretation and concepts rather than calculations or mathematical details. It develops ability to read the scientific literature to critically evaluate study designs and methods of data analysis. It introduces basic concepts of statistical inference, including hypothesis testing, p-values, and confidence intervals. Topics include comparisons of means and proportions; the normal distribution; regression and correlation; confounding; concepts of study design, including randomization, sample size, and power considerations; logistic regression; and an overview of some methods in survival analysis. The course draws examples of the use and abuse of statistical methods from the current biomedical literature.

Continuing Education Credits: N/A