Main Course

Program Schedule


This is the 2018 schedule for the 3-hour weekly lectures in the distance-learning Main Course component of the PPCR program.

 

Module 1 - BASICS OF CLINICAL RESEARCH

Tutorial Lecture, 29 March 2018 – Program Staff and PPCR Program Director – Felipe Fregni

• Opening remarks
• Syllabus and discussion of the program format
• Team introduction
• Sites introduction
• Using the Collaborative Learning Method: An overview
• Website tutorial
• Discussion

Lecture 1, 12 April 2018 – Steven Freedman & Camilia Martin

Introduction to Clinical Trials:

• Why perform a clinical trial?
• What is a clinical trial?
• Phase I studies; Phase II studies; Phase III/IV studies
• Introduction to ethics of clinical trials

Lecture 2, 19 April 2018 – Jonathan S. Williams

Selection of the Questions:

• Primary question
• Secondary question
• Adverse effects
• Ancillary questions
• Natural history
• Frequent errors

Lecture 3, 26 April 2018 – Michele Hacker

Study Population:

• Definition of study population
• Issues on generalization
• Trade-off: Internal validity vs. external generalizability
• Examples from landmark studies

Online Discussion: Ethical and Regulatory Issues

- Distinguishing clinical research from clinical practice and confidentiality
- Equipoise and ethics of clinical research
- Ethical considerations in randomized clinical trials
- Ethics of Phase I research
- Children in research
- Scandals and tragedies of research with human participants: Nuremberg, the Jewish chronic hospital, and Tuskegee
- Special Topic: Ethical dilemmas in clinical research
- Special Topic: Reasons patients refuse to participate in clinical trials
- Special Topic: Effective patient communication – challenges and recommendations
- Special Topic: Psychiatric symptom-provoking studies: An ethical appraisal

Lecture 4, 3 May 2018 – David Wypij

Basic Study Design:

• Observational studies
• Randomized control studies
• Nonrandomized concurrent control studies
• Historical controls/databases
• Cross-over designs
• Factorial design
• Studies of equivalence
• Large clinical trials

Lecture 5, 10 May 2018 – Mark Barnes

Integrity in Research:

• Disputes about authorship - when authorship fails
• The right or otherwise to publish data, patents, and grant funding
• Scientific integrity and misconduct
• Publication practices
• Conflict of interest

Lecture 6, 17 May 2018 – David Wypij

The Randomization Process:

• Fixed allocation randomization
• Simple randomization
• Blocked randomization
• Stratified randomization
• Adaptive randomization procedures (baseline adaptive randomization procedures)
• Mechanisms of randomization

Lecture 7, 24 May 2018 – Joseph Massaro

Study Blinding:

• Unblinded trials
• Single blind trials
• Double blind trials
• Triple blind trials
• Special problems in double blind studies – matching of drugs, coding of drugs, and assessment of blindness


Module 2 - BASIC STATISTICS

Lecture 8, 31 May 2018 – Roger Davis

Statistics – Basics:

• Data classification
• Data distribution
• Descriptive methods for categorical data
• Descriptive methods for continuous data

Lecture 9, 7 June 2018 – John Orav

Statistical Tests I:

• Estimation of parameters
• Comparison of population means (student t-test, ANOVA)

Lecture 10, 14 June 2018 – John Orav

Statistical Tests II:

• Correlation (Pearson and Spearman correlation coefficient)
• Nonparametric tests for two group comparisons (Mann-Whitney and Wilcoxon Signed Rank Test)
• Nonparametric tests for more than two group comparisons (Kruskal-Wallis and Friedman Two-Way)
• Analysis of variance
• Comparison of population (Chi-square test and Fisher's exact test)

Lecture 11, 21 June 2018 – Jessica Paulus

Sample Size Calculation:

• Dichotomous response variables
• Sample size for continuous response variables
• Sample size for equivalency of interventional studies
• Estimating sample size parameters
• Practical example: How to calculate sample size for a grant application

Lecture 12, 28 June 2018 – Roger Davis

Survival Analysis:

• Estimation of the survival curve (Kaplan Meier estimate)
• Comparison of two survival curves
• Covariate adjusted analysis
• Use of survival analysis in clinical research

 

29 June – 8 August 2018 – STATISTICAL STUDY PERIOD


Module 3 - APPLIED STATISTICS

Lecture 13, 9 August 2018 – Felipe Fregni

Statistical Tests III:

• Review of correlation
• Chi-square and Fisher's exact test

Lecture 14, 16 August 2018 – Felipe Fregni

Missing Data and Covariate Adjustment:

• Missing data
• Intention-to-treat analysis
• Covariate adjustment

Lecture 15, 23 August 2018 – Felipe Fregni

Meta-analysis and Subgroup Analysis:

• Subgroup analysis
• Comparison of multiple variables
• Meta-analysis of multiple studies

Lecture 16, 30 August 2018 – Farzad Noubary

Introduction to Regression Modeling:

• Adjusted analysis and predictors
• Introduction to multivariate analysis (analysis with more than one independent variable)


Module 4 - PRACTICAL ASPECTS OF CLINICAL RESEARCH

Lecture 17, 6 September 2018 – Felipe Fregni

Safety, Clinical, and Surrogate Outcomes:

• Reliability of measurements
• Validity of measurements
• Introduction to safety, clinical, and surrogate outcomes

Lecture 18, 13 September 2018 – Lotfi Merabet

Recruitment of Study Participants & Participant Adherence:

• Monitoring
• Reasons for participation
• Participant adherence
• Reducing dropout rates
• Considerations before participant enrollment
• Maintaining good participant adherence
• Adherence monitoring
• Special population of patients: The “skeptic”, the “pleaser”, “the information seeker”, “the hopeless”, “the money seeker”, “the professional research participant”, “the high maintenance participant”, “the noncompliant participant”

Lecture 19, 20 September 2018 – Felipe Fregni

Clinical Research in the Context of Individualized Medicine (N-of-1 Designs) & Business of Clinical Research:

• Basics and goals of N-of-1 designs: When to use
• Basics and goals of adaptive designs: When to use
• Introduction to individualized medicine
• Statistical issues
• Examples and discussion

Lecture 20, 27 September 2018 – Donald Halstead

Effective Communication in Clinical Research:

• Principles of good writing
• How to write a paper
• Oral presentations
• What is your brand?


Module 5 - STUDY DESIGNS

Lecture 21, 4 October 2018 – Scott Evans

Non-Inferiority Designs:

• Superiority trials
• Non-inferiority designs
• Goals of non-inferiority designs
• Choosing the non-inferiority margin

Lecture 22, 11 October 2018 – Felipe Fregni

Adaptive Designs & Interim Analysis:

• Clinical trials with medical devices
• Interim analysis
• Adaptive (flexible) design

(2nd lecture) Felipe Fregni

Phase III & Multicenter Trials:

• Challenges for multicenter trials
• Data monitoring
• Site selection
• Funding and regulatory issues

Lecture 23, 18 October 2018 – Clarissa Valim

Observational Studies:

• Basic designs of observational studies
• Retrospective studies or cohort studies
• Sample size for observational studies
• Bias and confounding
• Control of bias
• Control of the phenomenon of confounding

Lecture 24, 25 October 2018 – Heather Baer

Confounders in Observational Studies: Using the Method of Propensity Score:

• The issue of confounders in observational studies
• Methods to control for confounders
• Method of propensity score


Lecture 25, 1 November 2018 – Felipe Fregni

Special Panel: RCT vs. Observational Designs – How to choose?

• RCTs – why should we choose this design?
• Observational studies – why should we choose this design?

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