Harvard Schering-Plough Workshop

Supplements

Several speakers have provided materials and references that can be reviewed prior to the symposium.
 
SESSION I
  1. Glickman et al. (2009). Ethical and Scientific Implications of the Globalization of Clinical Research. N Engl J Med Volume 360:816-823, February 19, 2009.
SESSION II
  1. Antman et al. (2006). Enoxaparin versus Unfractionated Heparin withFibrinolysis for ST-Elevation Myocardial Infarction. N Engl J Med 354:1477, April 6, 2006.
  2. Steinberg et al. (2007). Global outcomes of ST-elevation myocardial infarction: Comparisons of the Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction study 25 (ExTRACT-TIMI 25) registry and trial. American Heart Journal 154(1): 54-61.
SESSION III
  1. Bernard Lo (2009). Chapter 22 of Ethical Issues in Clinical Research: A Practical Guide.    Philadelphia, PA: Lippincott Williams & Wilkins.
  2. Basic Principles on Global Clinical Trials. (PFSB/ELD) Notification No.0928010 dated Sept. 28, 2007. (Japanese Guidelines)
SESSION V
  1. Mehta et al. (2009). Optimizing Trial Design: Sequential, Adaptive, and Enrichment Strategies, Circulation 119:597-605.