Clinical Trials Administrator 2005-02-01

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. Read More

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. Read More

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. Read More

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. Read More

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. Read More

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. Read More

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February 1, 2005

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