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Bioresearch Monitoring Alert back issues
FDA fine-tuning its position on trials controlled by placebo.(Placebos)
December 1, 2005... PHILADELPHIA -- A clinical trial characterized as a "medical experiment" is perhaps the most inflammatory accusation being made in the courts today, and the fuel for this fire is placebo-controlled trials, attorneys told CBI Dec. 4. In clinical trials law suits, plaintiffs' attorneys...
Sponsors need to assure GCP compliance to reduce legal liability.(Sponsor/monitors)
December 1, 2005... PHILADELPHIA -- Given that clinical trials are under siege in the courts and in the public eye, trial sponsors would be wise to assure that GCPs and the importance of data integrity are fully embraced by IRBs, investigators and clinical staff. This was the message of several speakers at...
Patient privacy, informed consent becoming key issues in clinical trials litigation.(Consent/privacy)
December 1, 2005... PHILADELPHIA -- A central note sounded at CBI's meeting here Dec. 4-5 was patient privacy, the regulatory focus on it and the importance of conducting a sound informed consent process. "The government is definitely looking to enforce HIPAA [Health Insurance Portability and...
Trial design, exclusion criteria, vulnerable groups seen causing trial suits.(Litigation)
December 1, 2005... PHILADELPHIA -- Emerging theories aside, there are three primary areas currently fueling clinical trials litigation--design of clinical trials, exclusionary criteria used to recruit subjects and the handling of vulnerable populations, defense attorneys told a Center for Business...
Liability, federal rules dissuade use of alternative and central reviews; OHRP eyes national conference.(IRBs)
December 1, 2005... WASHINGTON -- IRBs are not using alternative review methods in great number--such as central IRBs--because of liability concerns and recommendations by attorneys at their institutions not to pass off responsibility to a central body if research is being conducted at that institution. ...