Randomized Controlled Trials
Scientific and Ethical Principles

March 9, 2007

The randomized controlled trial (RCT), more than any other kind of study, can have an immediate, significant impact on health care. It is therefore critical that reports of such investigations convey relevant information concerning the design, conduct, analysis, and generalizability of the trial. This is necessary so that readers will be able to make informed judgements about the study’s internal and external validity. Readers also need be assured that the trial was ethically conducted.
The purpose of this Workshop is to present an elaboration of a checklist of items that need to be considered to ensure that RCTs meet the highest scientific and ethical standards. The scientific items are from the CONSORT Statement (Consolidated Standards of Reporting Trials), a set of principles that have been adopted by a number of editorial boards and medical journals, including the Journal of the American Medical Association, Lancet, and the British Medical Journal. The ASSERT Statement (Assuring Ethical Randomized Trials) adds criteria for the ethical conduct of RCTs.

Instructors:

Chuck Kowalski is a Faculty Associate at CSCAR and Professor in the School of Dentistry at the University of Michigan. He joined the U-M in 1968, and has considerable statistical consulting experience in biomedical contexts, including work with pharmaceutical companies, the National Football League, the Nijmegen Growth Study, the Lancaster Cleft Palate Clinic, and the Free University in Amsterdam. He served as Chair of the Health Sciences Institutional Review Board from 1997-2003. He is currently Co-chair of that committee, and has interests in research ethics, especially with respect to study design and risk/benefit analysis. He continues his work with the U-M PEERRS web-based system for education in the responsible conduct of research.

Ken Guire is a Research Associate for CSCAR and for the Department of Biostatistics at The University of Michigan. He has done design and analysis on many grant-funded research projects at U-M, and is experienced with regression and ANOVA, factor analysis and discriminant analysis.

Audience:

All interested researchers and scholars.

Prerequisite:

Familiarity with basic statistical concepts and procedures.

Provisions:

The enrollee will receive lecture notes, a bibliography. Morning and afternoon refreshments provided. Break time for lunch (lunch not provided).

When:

Friday, March 9, 2007

8:30 a.m. - 5:00 p.m.

Location:

Fee:

Registration until February 23, 2007:

$150 for University of Michigan affiliated faculty, staff and students; 

$325 for others

Registration after February 23, 2007:

$180 for University of Michigan affiliated faculty, staff and students; 

$390 for others

Registration:

Call CSCAR at 734-764-7828. Enrollment is limited. Make check payable to CSCAR--University of Michigan, or give the University of Michigan short code to be billed. Send check to CSCAR, 3550 Rackham Bldg., University of Michigan, 915 E. Washington St., Ann Arbor, MI 48109-1070.