Optimizing Global Safety Reporting in Clinical Trials

In 2011, the FDA issued guidance on the reporting of adverse reactions in clinical trials, which called on trial sponsors to issue fewer, more informative reports. The results of a recent survey conducted by the Clinical Trials Transformation Initiative (CTTI), published in Clinical Trials, show that although sponsors embrace the guidance, they’re finding it hard to put into practice. […]

Placebo Response in Clinical Trials: Approaches to Mitigation

Industry trends show that a major contributor to trial failure is the increased rate of placebo response, while at the same time, placebo response across multiple therapeutic areas is now historically high and progressively increasing. Multiple reviews in different therapeutic areas including pain, neurology, psychiatry, dermatology, pediatric studies, etc. suggest a very distressing trend in that, […]

Clinical Researcher: Myths and Realities of Placebo Response – A 21st Century Prescription

Randomized, placebo-controlled clinical trials are the most challenging and complex aspect of development and commercialization of new drugs. The costs of conducting trials have continued to increase, trending ever upward.  One important indicator of clinical research quality is the extent to which trials detect effect signals (i.e., do trials separate experimental treatments from placebo). Rates […]

Managing the Unmanageable: Meeting the Challenge of Appropriate Safety Report Distribution

As clinical trials become more complex and increasingly global, the problem of over-distributing expedited safety reports to investigative sites has reached the point that demands a solution. The excessive volume of safety reports can cause investigators to miss important reports lost in the noise of non-significant event reports, and sometimes cause them to reconsider participating […]

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