Program Schedule
This is the 2022 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, 24 March 2022 – 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, 7 April 2022 – Albert Hofman
Introduction to Clinical Trials:
• Overview of clinical research
Lecture 2, 14 April 2022 – Michele Hacker
Study Population:
• Definition of study population
• Issues on generalization
• Trade-off: Internal validity vs. external generalizability
• Examples from landmark studies
Lecture 3, 21 April 2022 – 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 4, 28 April 2022 – 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
Lecture 5, 5 May 2022 – 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 6, 12 May 2022 – 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
Module 2 - BASIC STATISTICS
Lecture 7, 19 May 2022 – Roger Davis
Statistics – Basics:
• Data classification
• Data distribution
• Descriptive methods for categorical data
• Descriptive methods for continuous data
Lecture 8, 26 May 2022 – Felipe Fregni
Selection of the Question and Group Project Introduction:
• Primary question
• Secondary question
• Adverse effects
• Ancillary questions
• Natural history
• Frequent errors
Lecture 9, 2 June May 2022 – John Orav
Statistical Tests I:
• Estimation of parameters
• Comparison of population means (student t-test, ANOVA)
Lecture 10, 9 June 2022 – John Orav
Statistical Tests II:
• Chi-square and Fisher’s exact test
• Trend test for categorical data
Lecture 11, 16 June 2022 – Felipe Fregni
Statistical Tests III:
• Parametric and Nonparametric tests for more than two group comparisons (Analysis of variance (ANOVA) and Kruskal-Wallis)
• Correlation (Pearson and Spearman correlation coefficient)
Lecture 12, 23 June 2022 – 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 13, 30 June 2022 – 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
July 7 – August 11 2022 – GROUP PROJECT
Module 3 - APPLIED STATISTICS
Lecture 14, 18 August 2022 – Felipe Fregni
Missing Data and Covariate Adjustment:
• Missing data
• Intention-to-treat analysis
• Covariate adjustment
Lecture 15, 25 August 2022 – Felipe Fregni
Meta-analysis and Subgroup Analysis:
• Subgroup analysis
• Comparison of multiple variables
• Meta-analysis of multiple studies
Lecture 16, 1 September 2022 – David Wypij
Non-Inferiority Designs:
• Superiority trials
• Non-inferiority designs
• Goals of non-inferiority designs
• Choosing the non-inferiority margin
Lecture 17, 8 September 2022 - Felipe Fregni
Adaptive Designs & Clinical Research in the Context of Individualized Medicine (N-of-1 Designs)
•Interim analysis
• Adaptive (flexible) design
•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
Module 4 - PRACTICAL ASPECTS OF CLINICAL RESEARCH
Lecture 18, 15 September 2022 – 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, 22 September 2022 – Felipe Fregni
Safety, Clinical, and Surrogate Outcomes:
• Reliability of measurements
• Validity of measurements
• Introduction to safety, clinical, and surrogate outcomes
Lecture 20, 29 September 2022 – Donald Halstead
Effective Communication in Clinical Research:
• Principles of good writing
• How to write a paper
• IMARD
Lecture 21, 6 October 2022 - Howard Sesso
Multicenter Trials and industry-academia collaboration:
• Challenges for multicenter trials
• Data monitoring
• Site selection
• Funding and regulatory issues
Module 5 - STUDY DESIGNS
Lecture 22, 13 October 2022 – Heather Baer
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 23, 20 October 2022 – 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 24, 27 October 2022 – 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?