Clinical Trials Administrator Archives – May 1, 2004
May 1, 2004
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Given rules and regs, is emergency department research even possible?
Surveys of emergency department (ED) patients indicate most patients present there in moderate to severe pain. But ED physicians have a difficult time knowing which medications will work best for their patients because research specifically targeted to emergency conditions is lacking. -
Risk management making its way into clinical trials
Developing and adhering to a solid risk management strategy is an important foundation for preparing for the possibility of clinical trial problems, including those pertaining to patient safety, regulatory issues, and civil suits, experts say. -
Risk management begins with informed consent
Risk management issues that result in lawsuits often involve misunderstandings among subjects and clinical trials staff and investigators. By improving the informed consent process, these risks could be reduced, and heres how, according to experts. -
Data monitoring can affect risk management
Christopher Gallen, MD, PhD, vice president and chief of operations for clinical research and development at Wyeth in Collegeville, PA, highlights some strategies developed at Wyeth that are designed to help improve the clinical trials process and manage risk. -
Informed consent process at center of another suit
In March, members of the Havasupai Indian Tribe of northwestern Arizona filed two federal lawsuits seeking a total of $75 million in damages against Arizona State University (ASU), the Arizona Board of Regents, and three university researchers. The lawsuit claims that blood samples taken from tribe members as part of a diabetes study were destroyed, lost, or used in studies of schizophrenia, inbreeding, and population migration without the donors consent. -
Experimental devices and clinical trials
A report in the March 25 Philadelphia Inquirer regarding the use of experimental treatment on an infant in connection with a heart repair highlights a series of issues related to both the use of devices not approved by the Food and Drug Administration (FDA) and, in turn, their use on minors, including infants. -
News Briefs
Government launches gene therapy web site and New legislation proposed to increase grant access.