Course with Stephen Senn 2019


Czech National Group of the International Society for Clinical Biostatistics

in cooperation with the Institute of Computer Science AS CR in Prague, and, 

Faculty of Mathematics & Physics of the Charles University in Prague


Ustav informatiky AV CR
ISCB CR       
MFF UK Praha

are delighted to invite you to attend

 

a 1-day course on


Design and Analysis of N of 1 Trials

 

presented by

 

Prof. Stephen Senn, PhD, FRSE

 

Honorary Professor in Design, Trials & Statistics

The University of Sheffield, United Kingdom


WHERE                                            

(Ústav informatiky AV ČR)
Room # 318 
Pod Vodárenskou věží 2
Prague 8 - Ládví 
(Metro red line "C", exit "Ládví")
Czech Republic

WHEN                                               
8 November 2019 (Friday)

REGISTRATION DEADLINE       
21 October 2019 (Monday)

Payment has to be received by this date. Please, consult below an important information regarding the registration procedure.

COURSE ABSTRACT


N of 1 trials are trials in which individual patients are repeatedly treated with experimental and control treatments in a deliberate and designed manner using principles of control, randomisation and replication. Their uses include personalising treatment and increasing efficiency by reducing the number of patients it is necessary to study.

In chronic diseases, sets of n-of-1 trials (in which a limited number of patients follow an n-of-1 protocol) have great potential as phase IV trials for understanding components of variation but may also constitute possible Phase III programmes for rare diseases. They can also be used as phase II studies for proof of concept and dose-finding. However, they are often poorly analysed and, indeed, much of the published advice is poor.

This course will present the latest thinking on n-of-1 trials and cover not only their analysis through SAS®, R® GenStat® and meta-analysis packages but also approaches to design. They will also be critically examined as to their potential use in a) establishing average effects of treatment b) studying the extent to which such effects vary from patient to patient and c) optimising treatment for individual patients.

COURSE LEADER


This course will be given by Professor Stephen Senn, who is well-known for his work on the design and analysis of clinical trials and the application of statistics in drug development.

REFERENCES


1. Senn SJ. Cross-over Trials in Clinical Research. (Second edn). Wiley: Chichester, 2002.
2. Araujo A, Julious S, Senn S. Understanding Variation in Sets of N-of-1 Trials. PLoS One 2016; 11: e0167167.
3. Makubate B, Senn S. Planning and analysis of cross-over trials in infertility. Stat Med 2010; 29: 3203-3210.
4. Senn SJ. Sample size considerations for n-of-1 trials. Statistical Methods in Medical Research 2019; 28: 372-383.

TOPICS COVERED (updated)

  • Uses of n-of-1 trials and purposes of analysis
    • Showing the treatment can work
    • Understanding variation in effect
    • Predicting effects
  • Graphical presentation of results
    • Trellis plots
    • Dot plots
  • Causal analysis
    • Analysis of variance
      • Block structure and the Wilkinson & Roger notation
      • Main effect models
      • Allowing for interaction
    • Summary measures approaches
  • Predictive analysis
    • Mixed models
      • Estimation
      • Best linear unbiased predictors (shrunk estimates)
  • Meta-analysis approaches
    • Fixed effects
    • Random effects
  • Binary outcomes
    • Causal analysis
    • Predictive analysis
      • Non-linear mixed effects models
  • Design
    • Randomisation in cycles
    • Randomisation in patient blocks
    • Sample size determination

COURSE SCHEDULE

 8:00-9:00                     Registration
 9:00-12:00                   Morning session (part 1-2, includes 15 min coffee break)
12:00-13:00                  Lunch break
13:00-16:00                  Afternoon session (part 3-4, includes 15 min coffee break)
16:10-16:30                  Course conclusion

REGISTRATION RATES:

Category

Early Bird

(until 30 June 2019)

Regular

(1 July – 14 October 2019)

ISCB student member

1 500 CZK

60 EUR

2 000 CZK

80 EUR

ISCB regular member

2 000 CZK

80 EUR

2 500 CZK

100 EUR

Non-ISCB member – academia

4 000 CZK

160 EUR

5 250 CZK

210 EUR

Non-ISCB member – business

10 000 CZK

400 EUR

13 250 CZK

530 EUR

(*) Note: ISCB membership is required for 2018 and 2019

Payments by bank transfer ONLY
(* All international payments have to be made in EUR *)


ACCOUNT INFORMATION


For all domestic (CZK) and international transfers (EUR):

Bank's name and address:  Fio banka, a.s., V Celnici 1028/10, Praha 1, Czech Republic

Account owner                   Mezinárodní společnost pro klinickou biostatistiku v České republice, z.s.

Account number                 2100009829 / 2010  

IBAN                                  CZ3820100000002100009829

BIC code/SWIFT               FIOBCZPPXXX

 

Important!!: Before you make a payment, please, e-mail an inquiry to the Course Secretary Ms. Lenka Semeráková for confirmation. The number of course participants is limited to 30. Should the course reach its capacity, a notification will be placed here.

For institutions making payments on behalf of their employees: The payment identification number (variabilní symbol) is 20191108. Please, remember to state the name of an employee on whose behalf the payment is made in the comment for the payment recipient (poznámka pro příjemce).

 

COURSE VENUE

Institute of Computer Science
Czech Academy of Sciences
Pod Vodarenskou vezi 2
182 07 Prague
Czech Republic
 
COURSE SECRETARY

Ms. Lenka Semeráková
Dept. of Medical Informatics & Biostatistics
Institute of Computer Science
Czech Academy of Sciences
Tel. +420 266 053 640
E-mail: semerakova@cs.cas.cz
ċ
iscb_prague_2019.zip
(5302k)
Zdeněk Valenta,
29. 10. 2019 4:33
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