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CenterWatch Monthly March 2008 Issue

Monday, March 17, 2008

Unanticipated Problems Reporting Adverse Events to IRBs

FDA regulations governing adverse event reporting and IRBs have become outdated. At a time when clinical research is increasingly being conducted abroad and clinical trials are growing larger and more complex, IRBs are being inundated with single adverse event reports, which they have neither the resources nor the expertise to analyze. In recognition of this growing problem, both OHRP and FDA issued guidance last year. FDA has recognized and more narrowly defined the IRB’s role in clinical research oversight and underscored the necessity for sponsors to send IRBs analyzed reports on the data, in its draft guidance. Sites are caught between IRBs’ own clear reporting guidelines and sponsors taking a conservative position and demanding that sites report all adverse events to the IRB.

Global Growth Story Remains Strong for CROs in 2008, Beyond

Contract research organizations (CROs) report strong growth across all phases of drug development as cancellation rates remain at historic lows. Public CRO shares remain a strong sector in a shaky stock market as CROs report consistent revenue and profit growth. Global CROs are in a strong position in the industry as they solidify their leadership in global clinical trials in emerging regions. CROs such as Covance, ICON, Kendle, Parexel, PRA, PharmaNet, PPD, Quintiles and a few others are well positioned with global infrastructures in place to continue handling global growth.

Addressing the Shortage of Skilled Clinical Researchers in Europe

Difficulties finding and keeping suitably qualified clinical trials personnel have intensified in Europe. Observers agree that the available workforce simply isn’t large enough to meet staffing needs. The result has been spiraling salaries, as experienced professionals—and even relatively new recruits to the industry—capitalize on the staffing shortfalls.

Eye On Prostate Cancer

Second only to skin cancer, prostate cancer is the most common cancer, according to the American Cancer Society. In the United States, it is also the second most frequent cause of cancer-related death in men (after lung cancer), with approximately 30,000 men dying each year from the disease. CenterWatch has identified a pipeline of 23 pharmacotherapeutic agents in various stages of development for prostate cancer. Many of these affect either hormonal or immunological pathways, whereas others are novel formulations of more traditional chemotherapeutic agents.ch year from the disease.

To read the full articles for this issue, please click here.

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