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Data and Safety Monitoring and Interim Analysis in Clinical Trials

Clinical trials are typically planned to allow for early termination for ethical reasons. Early termination of a clinical trial may be warranted if the interim data indicate that a treatment is significantly superior (or inferior) or the safety of a treatment is unacceptable or if the clinical trial will not be able to generate sufficient data to reach any conclusion.

Prof. KyungMann Kim fra Departments of Biostatistics & Medical Informatics & Statistics, University of Wisconsin-Madison, USA (http://www.biostat.wisc.edu/People/faculty/kim.htm) will give a one-day course titled

"Data and Safety Monitoring and Interim Analysis in Clinical Trials"

in Bergen on Thursday 23 April 2009.

The course is espcially suited for biostatistical, medical and health related researchers and students with interest in randomised controlled trials:

"Course Description:

Clinical trials are typically planned to allow for early termination for ethical reasons.  Early termination of a clinical trial may be warranted if the interim data indicate that a treatment is significantly superior (or inferior) or the safety of a treatment is unacceptable or if the clinical trial will not be able to generate sufficient data to reach any conclusion.  An important role of a data and safety monitoring board is to evaluate safety and scientific validity of the clinical trial on an ongoing basis during the trial. This course will cover practical issues with data and safety monitoring and statistical methods for interim analysis in clinical trials.

This course will introduce data and safety monitoring and interim analysis in clinical trials to practicing statisticians and clinical investigators.  In the morning sessions, the roles and responsibilities of a data and safety monitoring board will be discussed.  In the afternoon sessions, targeting statisticians, after an initial review of the classical sequential methods such as sequential probability ratio tests and their modifications, the course will introduce statistical methods for interim analysis including group sequential methods, triangular tests and stochastic curtailment tests and review a number of clinical trials that were conducted with interim analysis.

Who should attend?

This short course is intended for individuals, both statisticians and clinical investigators, engaged in randomized controlled trials in academia, industry and government, who participate as member of a data and safety monitoring board (DSMB) or an independent data monitoring committee (IDMC) or who are responsible for establishing and operating DSMBs or IDMCs.  Basic familiarity with randomized controlled trials is assumed."

To register for the course, copy and paste the following into a response email and fill in the details:

Participant's
  Name:
  Title:
  Address:
  Email address:

Billing address:
  Name:
  Address:
  Email address:

I will attend (choose one only) the
  whole day course (8.30-16.30: registration fee 150 NOK)
  morning session only (8.30-12.00: registration fee: 100 NOK)
  afternoon session only (13.00-16.30: registration fee: 100 NOK)

Billing address:
  Name:
  Title:
  Address:
  Email address:

Deadline for registration is 31 January 2009!

Details for payment and place of event will be sent the registered participants soon after deadline.

For your information, prof. Kim will also give an open one-hour seminar on the topic "Transformation of Clinical Research in the US" targeting clinicians/research administrators on Wednesday 22 April. This will be announced separately.



Geir Egil Eide, DrPhilos,                                                        
Biostatistician / Associate Professor,
Centre for Clinical Research,
Haukeland University Hospital,
Armauer Hansen's House,
N-5021 Bergen,
Norway

http://www.uib.no/isf/people/geir.htm
Telephone: +47 55 97 55 34
Telefax:   +47 55 97 60 88
Email: Geir.Egil.Eide@Haukeland.No