Clinical endpoints in diabetes studies: a new approach

The pressure on national health care systems to have more effective drugs available to treat diabetes and prevent its complications, is well documented. All the anti-diabetic drugs approved by the Food and Drug Administration (FDA), European Medicines Agency (EMEA) or other Regulatory Authorities have been indicated to improve glycemic control, with glycosylated hemoglobin (HbA1c) being seen as the “gold standard” surrogate endpoint for the approval of products.

Solid Organ Transplantation

The history of solid organ transplantation dates back to the 2nd Century B.C., where transplantation
of organs was reported to have occurred in China. A more credible account of skin grafting was recorded by the Hindu surgeon Sushrata around 600 B.C.

ICON Profile

Eric Jay Goldberg, MD Senior Medical Director, Transplant and Immunology ICON Clinical Research

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Cardiovascular Outcomes Studies in type 2 Diabetes: Assessing the Endpoints

Date: 19 May 2009