Clinical Trials Administrator Archives – February 1, 2005
February 1, 2005
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Recent problems with Vioxx highlight need for post-marketing changes
The clinical trial industry watched with concern late last year as the national media drew attention to the problems with some painkillers COX-2 inhibitors, including rofecoxib (Vioxx) and celecoxib (Celebrex) which were linked to increased risk for heart disease. Two days before Christmas, the FDA issued a public health advisory recommending limited use of COX-2 inhibitors. -
Industry in need of major improvements
At the very least, pharmaceutical companies and other sponsors who rely on the clinical trial industry need to evaluate how they conduct post-marketing studies and make improvements that will increase public safety, a health law expert says. -
Risk management starts with contract
Research institution administrators could more easily protect their clinical trials against legal risks and other problems if they began the risk management process at the bargaining table when the research organization staff and for-profit pharmaceutical company staff hammer out the clinical trial agreement. -
Six prime areas for potential problems
Standard pharmaceutical company contracts for clinical trials typically include some less than desirable details, which research and institutional administrators may overlook if they are unfamiliar with contract language, a national clinical trial contract expert says. -
Accreditation of PIs may be the answer
Clinical research experts say the industry is beginning to recognize the need to hold clinical investigators to similar standards for practice and accreditation as physician specialists by requiring them to become certified in the practice of clinical research. -
News Brief: New bioterror vaccines are getting in the pipeline
The federal government has awarded $232 million to fund research and development of new vaccines against three potential agents of bioterrorism: smallpox, plague, and tularemia. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), will administer the contracts.