introduction to clinical research: a practical course · 09h00 Introdução e apresentação do...
Transcript of introduction to clinical research: a practical course · 09h00 Introdução e apresentação do...
MODULE I - INTRODUCTION
HOUR SUBJECT SPEAKER
13
NOV’15 (Friday)
09h00 Introdução e apresentação do curso AVC, JF, MCM
09h30 O que é a investigação clínica? JF
10h30 COFFEE
11h00 Investigação clínica e translacional: uma experiência de vida MCM
13h00 LUNCH
14h30 Como...escrever um resumo científico (abstract) IPM
15h00 Como... escrever um artigo científico JF
16h30 COFFEE
17h00 Como...responder aos comentários dos revisores JF
14
NOV’15 (saturday)
09h00 Tipos de estudos clínicos e sua avaliação crítica AVC
11h00 COFFEE
11h30 Como...comunicar medicina e ciência com o público AVC
13h00 Encerramento do módulo AVC
AVC – António Vaz Carneiro | JF – José Ferro | MCM – Miguel Carneiro de Moura | IPM - Isabel Pavão Martins
APPLICATION FORM
admissions2015| 16
introduction to clinical research: a practical course
admissions2015| 16
introduction to clinical research: a practical course
MODULE II ETHICS IN CLINICAL RESEARCH
HOUR SUBJECT SPEAKER
27
NOV’15 (friday)
09h00 Ethical framework for biomedical research AB
10h45 COFFEE
11h15 Typology and ethical issues of clinical trails FMV
13h00 LUNCH
14h00Problematization of the main actual and future developments of the biomedical research
MMR
15h30 COFFEE
16h00 Ethical framework in animal experimentation JMS
17h00 Ethical issues of using animals in biomedical research JM
28
NOV’15 (saturday)
09h00 Ethical analysis and discussion of research protocols AB
10h30 COFFEE
11h00 Ethical analysis and discussion of clinical cases AB
12h00 Clinical ethical behavior of researchers AB
AB – António Barbosa | FMV – Fernando Martins do Vale | JM – Joana Marques | JMS – Jorge Marques da Silva | MMR – Mário Miguel Rosa
APPLICATION FORM
MODULE III DIAGNOSTIC STUDIES
HOUR SUBJECT SPEAKER
18
DEC’15 (friday)
09h00 Reception and needs assessment All
09h30 The cognitive process in the differential diagnosis AVC
11h00 COFFEE
11h30Measures of association in diagnostic studies: sensitivity, specificity, positive and negative predictive values, likelihood ratios
AVC
13h00 LUNCH
14h30 Critical appraisal of a diagnostic study: group work All
16h00 COFFEE
16h30 How to report a diagnostic study: the STARD system AVC
19
DEC’15 (saturday)
09h00 Screening tests: benefits and harms AVC
10h30 COFFEE
11h00 Critical appraisal of a diagnostic study: group work All
12h00 Closing of the module AVC
AVC – António Vaz Carneiro
APPLICATION FORM
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introduction to clinical research: a practical course
MODULE IV CAUSATION STUDIES
HOUR SUBJECT SPEAKER
08
JAN’16 (friday)
09h00 -
18h00
Introduction
JF
Causality, confounders and causal inference
Observational studies
Cross-sectional studies
Case- control studies
Measurements in clinical studies
Risk and prognosis
Study validity
Bias
Multivariate analysis (Prof.ª Catarina Fonseca)
Clinical studies in genetics (Prof.ª Sofia Oliveira)
09
JAN’16 (saturday)
09h00 -
13h00
Practical exemples and case-studies
JF
Discussion of publications
Sample size calculation
Risk analysis
Design of a cross-sectional study
Design of a case-control study
JF – José Ferro
APPLICATION FORM
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introduction to clinical research: a practical course
MODULE V - CLINICAL TRIALS
HOUR SUBJECT SPEAKER
05
FEB’16 (friday)
09h00 Preclinical development IB
10h30 COFFEE
11h00 Clinical development MMR
13h00 LUNCH
14h00 Assessment tools and outcomes RF
15h30 COFFEE
16h00 Critical appraisal of clinical trials JF , DC
06
FEB’16 (saturday)
09h00 Design of clinical trials and protocol development JF, DC
10h30 COFFEE
11h00 Design of clinical trials and protocol development JF, DC
JF – Joaquim Ferreira | IB – Isabel Boaventura | MMR – Mário Miguel Rosa | RF – Ricardo Fernandes | DC – Daniel Caldeira
APPLICATION FORM
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introduction to clinical research: a practical course
MODULE VI - STATISTICAL TESTS
HOUR SUBJECT SPEAKER
04
MAR’16 (friday)
10h00 - 19h00
Introduction and descriptive statistics
RR
Concept of a statistical test
Significance, type I, type II errors, and power
Tests to compare independent samples
Confidence intervals
05
MAR’16 (saturday)
09h00 - 13h00
Relative risk, odds ratio
RRBasic ideas of survival analysis: Kaplan-Meier, log-rank test
RR – Ruy Ribeiro
APPLICATION FORM
admissions2015| 16
introduction to clinical research: a practical course
MODULE VII PROGNOSTIC STUDIES
HOUR SUBJECT SPEAKER
18
MAR’16 (friday)
14h00 Introduction and presentation of the module PC
14h15 How to design prognostic studies
PC
Designing a Prognostic Study
Definition of Prognostic Factors
Definitions and assessment of Outcomes
Bias in Prognostic Studies
15h15 Pratical exercisePC
Critical appraisal of Prognostic Studies
16h00 Discussion PC
16h15 COFFEE
16h45 How to individualize the prognosis To be confirmed
How to develop Prognostic Models
Multivariate analysis
Calibration and discrimination
18h15 Pratical exercise To be confirmedCritical appraisal of Prognostic Models PC
18h45 Discussion
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introduction to clinical research: a practical course
MODULE VII - PROGNOSTIC STUDIES
19
MAR’16 (saturday)
09h00 Validation of prognostic models
ACFClinical prediction rules
Overtraining and overfitting
Validation techniques of Prognostic Models: apparent, internal, external
10h15 Pratical exerciseACF
Critical analysis of studies validating prediction models
11h00 COFFEE
Practical exercises I – with SPSS software
PCAims of this session:
To design a Prognostic Study
To select and define “predictors” and “outcomes” variables
To assess Prognosis in a prospective cohort
13h00 LUNCH
14h30 Practical exercises II – with SPSS software
PC
Aims of this session:
To assess Prognosis in a prospective cohort
To develop a prediction model
Critical analysis of the prognostic model
16h30 COFFEE
17h00 Impact of prognostic models in clinical practice
PCApplication and impact of Prognostic Models in clinical practice
Limitations of the current research on Prognosis - how to improve
18h00 Closing Remarks
PC – Patrícia Canhão | ACF - Ana Catarina Fonseca
APPLICATION FORM
MODULE VIII SYSTEMATIC REVIEWS
HOUR SUBJECT SPEAKER
01
APR’16 (friday)
09h00 Welcome Note JC , AVC
09h15 Session 1 - INTRODUCTION TO SYSTEMATIC REVIEWS
AVCPrinciples of evidence-based medicine
Explain the importance of using an evidence-based approach
Levels of evidence
Systems of recommendation
09h45 Systematic reviews
AVCSystematic reviews vs. narrative reviews
Outline the process of undertaking a systematic review
10h15 Discussion
10h30 COFFEE
11h00Session 2 - EVALUATION AND APPRAISAL OF CLINICAL TRIALS
RFEvaluation and appraisal of randomized controlled trials
Describe different types of bias which randomised trials are at risk of
Identify and assess the risk of bias in randomised trials
Plan how to summarise and incorporate risk of bias assessments
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introduction to clinical research: a practical course
MODULE VIII - SYSTEMATIC REVIEWS
HOUR SUBJECT SPEAKER
01
APR’16 (friday)
11h45 Practical exerciseRF
Critical appraisal of clinical trials papers
12h45 Discussion RF
13h00 LUNCH
14h30 Session 3 - PROTOCOL OF A SYSTEMATIC REVIEW
JA
Writing a protocol
Outline the key components of a protocol
Explain the PICO approach to defining the question and objectives for the protocol
Prepare the background section of the protocol
Describe the elements of the methods section
15h15 Session 4 - SEARCH STRATEGY
Searching for studies
Planning the search process
Constructing a search strategy
Managing and reporting the search results
JA
16h00 Practical exercises: Searching for studies in Medline JA
16h45 COFFEE
17h15 Session 5 - STUDY SELECTION and DATA COLLECTION
DCImplementation of the selection process
Discuss methods used to minimise errors and bias in collecting data
Decide what data to collect from studies
Devise an appropriate form for collecting data from included studies
18h45 Overall Discussion All
02
APR’16 (saturday)
09h00 Session 6 - FUNDAMENTALS OF META-ANALYSIS
JCIntroduction to meta-analysis
Explain the difference between meta-analysis and systematic reviews
Understand the steps of conducting a meta-analysis
Recognise the elements of a forest plot and interpret the results
09h30 Which data should be pooled in a meta-analysis?
ATSelect effect measures for dichotomous and continuous outcome measures
Calculate effect measures from raw data e.g. risk ratio and odds ratio
Calculate mean difference and standardised mean difference
10h30 How to pool the results?AT
Fixed and random effect methods
11h30 COFFEE
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APPLICATION FORM
MODULE VIII - SYSTEMATIC REVIEWS
HOUR SUBJECT SPEAKER
02
APR’16 (saturday)
11h45 Session 7 - HETEROGENEITY and other bias in meta-analysis
AT
HeterogeneityUnderstand the meaning of heterogeneity
Identify differences between clinical, methodological and statistical heterogeneity
Describe the strategies for handling heterogeneity
12h45 Bias in meta-analysis and complementary techniques
ATPublication bias
Cumulative meta-analysis
Sensitivity analysis
13h45 Discussion
14h00 LUNCH
15h00 Exercises with meta-analysis software AT, JC
16h30 COFFEE
16h45 PRACTICAL EXERCISES IIAT, JC
Exercises with meta-analysis software
18h00 CLOSING REMARKS All
JC – João Costa | AVC – António Vaz Carneiro | RF - Ricardo Fernandes | JA - Joana Alarcão |
DC - Daniel Caldeira | AT - Aurélio Tobias