Agenda for Computers in Perinatal Medicine meeting 2002

Summary of Proceedings for the 2005 SMFM Annual Meeting: Perinatal
Epidemiology Scientific Forum
Topic: Methodological Controversies in Obstetric Clinical Research
Course Description (as described in the meeting program): The focus of this
scientific forum will be two common areas of controversy in clinical research: stopping
clinical trials and selecting meaningful & important primary outcomes. The Forum
attendees will first review the operations of Data Monitoring & Safety Committees
(DMSC), highlighting general topics of debate and conflict regarding committee conduct.
Second, specific examples will be presented in which a clinical trial was stopped based
on a controversial decision by a DMSC. Points and counterpoints regarding the decision
to cease each trial will be outlined. Third, the benefits, limitations and pitfalls of using
surrogate or composite primary outcomes in clinical research will be presented,
incorporating examples from the obstetrical literature.
Moderator: David Stamilio, MD, MSCE, University of Pennsylvania Medical Center,
Philadelphia, PA.
Speakers:
• Dwight J. Rouse, MD, MSPH, Center for Research in Women’s Health and
Division of Maternal Fetal Medicine, University of Alabama at Birmingham,
Birmingham, AL.
• Elizabeth Thom, PhD, George Washington University Biostatistics Center,
Washington, DC.
• Mark Klebanoff, MD, MPH, Director, Division of Epidemiology, Statistics, and
Prevention Research, National Institute of Child Health and Human
Development, Bethesda, MD.
Proceedings:
Dr. Stamilio provided a brief description of the course goals and introduced the speakers
and their respective topics. (5 minutes)
Dr. Rouse presented a lecture entitled “Data Monitoring and Safety Committees
(DMSC): Operations & Conflicts.” In this lecture, he described the purposes and
functions of a DMSC. He described how to identify which studies need a DMSC. He also
described who should comprise the DMSC and how the committee should be managed,
including a charter, stopping rules, and guidelines for adjudicating committee
disagreements. (30 minutes)
Dr. Thom presented a lecture entitled “DMSC Controversies: When should a trial be
stopped?” In this lecture, she described reasons for Data and Safety Monitoring
Committees to recommend stopping randomized clinical trials and highlighted the
importance of establishing reasons for stopping a trial before the planned number of
patients have been recruited. She described some of the issues involved in the decision,
including statistical guidelines. She illustrated her points using three detailed examples
drawn from the MFMU Network, including the Steroids Trial (RCT of single course vs
repeated weekly steroids in women at high risk of preterm delivery 24-31 weeks), the
Progesterone Trial (RCT of weekly injections of 17 α hydroxy-progesterone caproate vs