More Trials & Tribulations for Clinical Monitoring

Clinical trial litigation is on the rise in the drug arena, and the effects could soon spread to the device industry. The Legal Times (Washington, DC) has reported that lawsuits are increasing and often pursue every person and institution in their paths. If device manufacturers want to avoid legal action, they need to protect themselves by making sure they’re not cutting corners.

The first step is to hire the proper staff to monitor clinical trials, says Steven Mayo, president of Austin, TX–based Emissary International, a contract research organization. "America seems to be in a lawsuit craze, and the number of high-profile lawsuits seems to be increasing," says Mayo. "The class-action lawsuit trend is a negative [development] that’s really affecting [the device] industry."

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Clinical Trial Accrual Hampered by Many Factors

In recent years, cancer patients are more knowledgeable and willing to participate in clinical trials, but issues pertaining to physician enthusiasm, design requirements, and enrollment procedures now pose large barriers to patient accrual, finds two new Cancer studies. Since previous research has predominantly focused on patient and physician perspectives, Canadian researchers interviewed clinical research associates (CRAs), whose work spans all stages of clinical trials, to gain new insight into the factors influencing enrollment. The CEO of an Austin, Texas-based contract research organization (CRO), which designs trials and staffs CRAs, told the Watch (9/24/02) that the strict participation guidelines for oncology-related clinical trials make meeting accrual goals for experimental cancer therapies particularly difficult.

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