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

admissions2015| 16

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

admissions2015| 16

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

admissions2015| 16

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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admissions2015| 16

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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admissions2015| 16

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