Monday, April 30, 2007
The American Association for Cancer Research (AACR) has formed a collaborative group with the U.S. Food and Drug Administration (FDA) and the National Cancer Institute (NCI) called the Cancer Biomarkers Collaborative (CBC). The purpose of the CBC is to champion the use of validated biomarkers in clinical trials. Its mission is to develop a set of guidelines for effectively integrating predictive biomarkers into oncology trials.
The Centers for Medicare and Medicaid Services (CMS) has proposed new coverage rules for payments to Medicare recipients involved in clinical trials. The rules would revise the agency’s Clinical Trial Policy’s national coverage determination (NCD) system and push additional transparency requirements on trial sponsors.
Healthy Pipeline of Clinical Trials in Russia
The growth of Russia’s clinical research market in the past five years has been impressive. Nearly double the number of clinical trials were approved in 2006 as were in 2000, and the number of patients participating in global clinical trials conducted in Russia more than tripled between 2002 and 2006. In addition, between 2001 and 2006, Form FDA 1572s were filed by more than three times the number of investigators in Russia.
The financial model of the Center for the Study of Neurodegenerative Diseases at the University of Virginia leaves much to be desired. Facing shortfalls during a clinical trial studying a drug to treat amyotrophic lateral sclerosis (ALS), James P. Bennett, Jr., director of the center and the physician sponsor of the clinical trial, solicited trial subjects for money to continue to study the drug’s effects on them, according to an article in the Wall Street Journal.