Tentative Program

　　Tentative Program ? Distance-Learning Clinical Research Training

　　(24 weekly lectures of 2 hours of duration)

　　Module 1: Basics of Clinical Research

　　Lecture 1 ? March 13, 2008

　　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 - March 20, 2008

　　Selection of the Questions:

　　Primary question

　　Secondary question

　　Adverse effects

　　Ancillary questions

　　Natural history

　　Frequent errors

　　Lecture 3 ? March 27, 2008

　　Study Population:

　　Definition of study population

　　Issues on generalization

　　Practical aspects: recruitment

　　Lecture 4 ? April 3, 2008

　　Basic Study Design:

　　(note that detail of each study will not be given at this lecture)

　　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 - April 10, 2008

　　The Randomization Process:

　　Fixed allocation randomization

　　Simple randomization

　　Blocked randomization

　　Stratified randomization

　　Adaptive Randomization Procedures (baseline adaptive randomization procedures)

　　Mechanisms of randomization

　　Lecture 6 - April 17, 2008

　　Blindness:

　　Type of Trials ? 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: Statistics

　　Lecture 1 - April 24, 2008

　　Statistics ? Basics:

　　Data classification

　　Data distribution

　　Descriptive methods for categorical data

　　Descriptive methods for continuous data

　　Lecture 2 - May 8, 2008

　　Statistical Tests:

　　(note: only basics of statistical tests will be covered)

　　Estimation of parameters

　　Comparison of population proportions

　　Comparison of population means

　　Correlation and regression

　　Lecture 3 - May 15, 2008

　　Sample Size:

　　Dichotomous response variables (two independent samples, paired dichotomous response)

　　Sample size for continuous response variables (two independent samples)

　　Sample size for repeated measures

　　Sample size for equivalency of interventional studies

　　Estimating sample size parameters

　　Lecture 4 - May 29, 2008

　　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

　　Lecture 5 - June 5, 2008

　　Other Issues in Data Analysis 1:

　　Poor quality or missing data

　　Intention-to-treat analysis

　　Competing events

　　Covariate adjustment

　　Lecture 6 - June 12, 2008

　　Other Issues in Data Analysis 2:

　　Subgroup analyses

　　Comparison of multiple variables

　　Use of cutpoints

　　Meta-analysis of multiple studies

　　Module 3: Assessments and Data Collection

　　Lecture 1 - June 19, 2008

　　Recruitment of Study Participants:

　　? Strategies and Sources

　　? Monitoring

　　? Problems

　　? Reasons for participation

　　? Reducing dropout rates

　　Lecture 2 - June 26, 2008

　　Data collection and quality control:

　　? Problems in data collection (major problems)

　　? Minimizing poor quality data

　　? Training, pre-testing

　　? Techniques to reduce variability

　　? Data entry

　　? Quality monitoring

　　Lecture 3 - July 3, 2008

　　Assessing and Reporting Adverse Events

　　Determinants of adverse effects (length of follow-up, frequency of events and individual susceptibility)

　　Reporting adverse events

　　Lecture 4 - July 10, 2008

　　Assessment of Health-Related Quality of Life:

　　? Primary HRQL dimensions

　　? Secondary HRQL dimensions

　　? Selection of HRQL instruments

　　? Modes of administration

　　? Frequency of assessment

　　? Symptom expression

　　? Functional impact

　　? Interpretation (scoring)

　　Lecture 5 - August 21, 2008

　　Participant Adherence:

　　? Considerations before participant enrollment

　　? Maintaining good participant adherence

　　? Adherence monitoring

　　? Special populations

　　Lecture 6 - September 4, 2008

　　Design and Analysis of Surveys:

　　? Instrument design

　　? Design of survey administration

　　? Sample design

　　? Data collection

　　? Analysis

　　Module 4: Study designs

　　Lecture 1 - September 11, 2008

　　Observational Studies ? part I:

　　? Basic designs of observational studies

　　? Retrospective studies or cohort studies

　　? Sample size

　　Lecture 2 - September 18, 2008

　　Observational Studies ? part II:

　　? Bias and confounding

　　? Control of bias

　　? Control of the phenomenon of confounding

　　Lecture 3 - September 25, 2008

　　Experimental Design - issues of uncontrolled studies:

　　? Before and after comparison in a single group

　　? Temporal variation of disease

　　? Temporal variation of the staff, equipment and environment

　　? Statistical regression to mean

　　? Learning effect

　　? Psychological effect

　　Lecture 4 - October 2, 2008

　　Experimental Design ? part I:

　　? Parallel-group design

　　? Variants of parallel group design (completely randomized parallel group design)

　　? Stratified parallel group design

　　? Parallel group randomized block design

　　? Balance incomplete block design

　　? Dose escalation and dose titration

　　Lecture 5 - October 9, 2008

　　Experimental Design ? part II:

　　? Complete cross-over design

　　? Simultaneous treatments design

　　? Cross-over design on a single patient

　　? Factorial design

　　Lecture 6 - October 16, 2008

　　Other designs:

　　? Equivalence and non-inferiority studies

　　? Interim analyses

　　? Adaptive (flexible) design

　　? Studies with repeated measurements

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