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Clinical Trials & Survival Analysis

Some of the material relating to the course Clinical Trials given in the Tampere School of Public Health in the University of Tampere from 16 April to 27 April 2012 is available on this page. Lecture notes etc are in .pdf form and may be read and printed with Adobe Acrobat. The data sets are in R (some other formats may be available by special request), clicking on them gives the option of downloading or running from the web sources. Downloading is recommended. The web pages and links have been tested using IE 9 running under Windows 7 but it is expected that they should be accessible using your favourite browser.

Further material will be added to this page over
the coming days and at some later stage solutions to the exercises
and copies of lecture slides etc will be provided here.
Nick Fieller, 01/04/2012

Lecture notes:

Statistics in Clinical Trials: Lecture Notes (Web Version)

Statistics in Clinical Trials: Lecture Notes (print version)

Survival Data Analysis: Lecture Notes (Web Version)

Survival Data Analysis: Lecture Notes (print version)

The Web versions of the lecture notes have Lists of Contents that are
hot-linked for easy opening at specific sections.
The print versions are prepared with two pages per sheet for easy printing.

Sample Size Tips

Click here for brief notes on which formula
and which R function to use for calculating power and sample sizes

Lecture Slides & Recordings:

Links are given below to the pdf versions (in handout format) to
the slides displayed in the course. Additonally there are links
to recordings (made with the Echo360 system) of slides and other
material as displayed on the data projector with synchronised sound.
For unknown reasons not all recordings succeeded.
A complete set of recordings made in a closely similar course
is available here

Clinical Trials

1: Introduction and background
Recording (45 mins)

2: Basic trial analysis
Recording (45 mins)

3: Randomization
Recording (50 mins)

4: Sample size calculations
Recording, part 1 (35 mins)
Recording, part 2 (35 mins)

5: Multiplicity
Recording, part 1 (35 mins)
Recording, part 2 +sample size facilities (40 mins)

6: Crossover trials
Recording (50 mins)

7: Binary responses
Recording (35 mins) Miscellaneou binary responses
Recording (25 mins) Logistic models

Survival Data Analysis

Introduction & basic concepts
Recording (45 mins)

Single sample non-parametric methods
Recording (37 mins)

Parametric models
Recording (40 mins)

Two sample comparisons
Recording (35 mins)


Recording Tutorial on Survvival Analysis in R and SPSS (60 mins)

Parametric Regression
Recording (40 mins)

Proportional Hazards Regression Part 1
Recording (45 mins)

Proportional Hazards Regression Part 2
Recording (45 mins)

Micro Lab Sessions

Micro1: Revison of t-tests; randomization; power & sample size calculations (20/04/12)
Micro2: Survival analysis: K-M Plots and log-rank tests (25/04/12)
Micro3: Survival Analysis: semi-parametric and parametric analysis(27/04/12)

Exercises

Click here for the Exercises on Clinical Trials and here for the printing version, two sheets to the page.
There are thirty-four exercises which cover most of the topics in the course.
Some of the exercises require access to web pages (e.g. to PubMed and the register of clinical trials). Others will need to be done
by hand and others will need use of R. Many may seem easier to do by hand than with R but the intention is that you should do them first
by hand and then use R until you become more familiar with using R. Many of the questions can be answered very quickly using R
(e.g. some of the sample size questions) but others are quite substantial and will take considerably longer.

Click here for the Exercises on Survival Data Analysis and here for the printing version, two sheets to the page.
There are fifteen exercises which cover most of the topics in the course.
Some of the exercises require use of specialist libraries in R (such as eha which you will need to download and install). Some simple exercises are intended to be done
by hand but most will need use of R.
Solutions will be provided over the week or two following completion of the course so keep an eye on the course web pages
if you want to see the solutions.

Guides to R

The practical session in this course will involve the use of R. A brief guide to installing and getting started with R is given here.
A recording of a brief lecture (27 min) illustrating some of the topics in the notes is given here.
A brief introduction to R with more information on use in statistics (but orientated to Sheffield campus network users) is given here.
More information is given on the CRAN home page.

Solutions to exercises

Here is the link to the solutions to the exercises on Statistics in Clinical Trials.
Here is the link to the solutions to the exercises on Statistics in Survival Analysis.

R Script Files for Task Sheets and Exercises etc:

To follow later

     

Download Data Sets:

NB: you should save R.data files to your hard disk by right-clicking
and choosing "Save Target As...".
Do not try to open them from the web page.
All Rdata sets (zipped folder)
All SPSS data sets (zipped folder)

Clinical Trials

Hours Sleep

Liver cirrhosis data

Survival Data Analysis

Survival times of Australian tea spoons

Tumour remission times

Lung cancer survival times

Brain tumour survival times times

Leukaemia remission times

Prostatic cancer survival

lymphoma survival

ovarian cancer survival

kidney tumor survival

methtrex survival

Links:

Click here for Ben Goldacre's Bad Science page

Click here for the NHS Behind the Headlines pages

Click here for link to the British Medical Journal

Click here for sample size programmes.

Click here for the registry of clinical trials.

Click here for PubMed.

Course Desciption and schedule

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This page is maintained by the Dr Nick Fieller and was last updated on 3 May 2012.