Page 1

Lima, Peru

28-30 October 2015

Page 2

SLACOM –ESMO Clinical Trials Workshop

Key Figures

35 participants

23: Peru

7: Chile

2: Costa Rica

1: Brazil; Bolivia; Ecuador

11 speakers

2: Europe

1: North America

8: Latin America (working around the world)

Page 3

Material provided (ESMO bag containing contents below)

Printed Programme

Peruvian National Regulations

ICH Harmonised handbook

ESMO Glossary in Molecular Biology of Cancer and

Molecular Techniques

USB with all presentations

Block for notes & pen

Page 4

Final Programme

Wednesday 28 October 2015

Welcome Lunch (Chairs: C. Vallejos, C.Rolfo)

(Personal presentations)

Knowing the institutions: introduction, history, work and future perspectives

ESMO: C. Zielinski SLACOM: C. Vallejos

Introduction:

Clinical Cancer research Worldwide (C. Zielinski)

Clinical Research in Latin American (H Gomez)

SWOT (strengths, weaknesses, opportunities and threats)

(Groups, counties interactions) directed by : Christian Rolfo

Andres Cardona -Luis Raez – Ana Ton

SWOT OF Clinical Trials in LATAM

Exercise by groups and discussion

Page 5

Clinical Cancer Research Concepts

Introduction Phase I trials (David Hong)

Single Arm Phase II ( Christian Rolfo)

Randomized trials Phase II and Phase III (C. Zielinski)

Phase IV (Luis Raez)

Welcome Dinner: Meet the Professor: My experience with clinical trials - C. Zielinski

Page 6

Thursday 29 October 2015

Ethics Principles

History (Nuremberg,Belmont,Helsinski) (C. Vallejos)

Regulation in Clinical Trials

FDA (David Hong)

EMA (Christian Rolfo)

LOCALS : Colombia and Peru: Different approaches in legislation in the same geographic area (Andres Cardona -Carlos Castañeda)

Statistics (Urania Dafni)

Phase I design

Phase II designs:

o Single arm design:

o One and two-stage designs (Simon’s)

o Randomised designs

o Adaptive designs

Variability and Bias

Descriptive statistics

Common plots: Kaplan Meier, Waterfall, Forest plot

Inform Consent Form (ICF) (Denisse Bretel)

Description

Parts

Exercise (review of different ICF, explanation and talk with a patient) Andres Cardona, Luis Raez, Christian Rolfo, Denisse Bretel

Lunch (Meet the Professor, Career development): David Hong

Clinical Trial Design: Hypothesis IIT(the answer is the question) (David Hong)

Page 7

Observational Trials Design – Luis Raez

Cohort

Case Control

Statistics (Randomised Trials): (Urania Dafni)

Non-inferiority and Superiority Trials

Hypothesis Testing

Sample size, Power, Clinical Significance vs Statistical significance

Estimating sample size parameters

Endpoints

Surrogate & Composite Endpoints

Exercise: Design a Clinical Trial (groups) & discussion David Hong, Denisse Bretel, Luis Raez, Ana Oton

Discussion: Urania Dafni & Christian Rolfo Writing a protocol: Christian Rolfo Good Clinical Practice (Investigator Training Programme) Pfizer Investigator Training Team

Page 8

Faculty dinner

Page 9

Friday 30 October 2015

Statistics Common Errors – Urania Dafni

Funding and Implementations -

Industry and CROs – Ana Oton

Academic Groups – C. Zielinski

Grants – Ana Oton

Reading the Literature With a Critical Eye (A. Cardona)

Statistics (Results): Urania Dafni

Multiple Testing

Interim analysis

Subgroup Analyses

Meta-analysis

Lunch (Meet the Professor): Christian Rolfo

Exercises : Ana Oton, Andres Cardona, Urania Dafni

Review publications and comments per groups

How to write an abstract/publication – C. Zielinski – C. Rolfo

What makes a great paper?

Tips to get your research published in high impact journals

Which high impact journals are interested?

Data – Denisse Bretel – Urania Dafni

Data Entry

Data management

Quality and Metrics

Good Clinical Practice (Investigator Training Program) Pfizer Investigator Training Team

Test for certificate in GCP & event test

Page 10

Closing Dinner – Awarding of Certificates and closing remarks

Page 11

Survey

1. How did you hear or learn about this conference?

Brochure

Flyer

ESMO website

Mail from a colleague

2. Please specify the main reason for attending this conference:

Content

Networking

Personal growth & development

Speakers

Other

3. Did the conference fulfill your reason for attending?

Yes – Absolutely

Yes -- But not to my full extent

No

No at all!

Page 12

4. What was the most beneficial aspect of the conference?

Answers:

Exercises ****

Interaction with Speakers ***

Networking **

Statistics **

Speakers’ experience*

To “Open my mind”

Quality of Presentations

Industry - Academia Vision

5. Would you recommend this conference to others?

Yes

Maybe

No

No! I'm not crazy!

6. Please indicate your overall satisfaction with this conference

Very Satisfied - Somewhat Satisfied - Neutral - Somewhat Dissatisfied - Very

Dissatisfied

Conference Content

Registration Process

Venue

Food & Beverage

Organisation

Interaction with speakers

Page 13

7. How many external conferences/seminars do you attend, on average, in a year?

Answers:

1 or 2 per year

8. What other topics or themes are of interest to you for a conference?

Answers:

Exercises

Translational research

Biomarkers

Collaborative Groups

Management of AE

Retrospective trials

Review our ongoing protocols

Split the statistics with exercises

Immunotherapy