Clinical Trial Engagement Network

Enrollment of racially/ethnically diverse participants in traumatic brain injury trials: Effect of availability of exception from informed consent

Clin Trials: April 2014 Background The Final Rule regulations were developed to allow exception from informed consent (EFIC) to enable clinical trial research in emergency settings where major barriers exist for informed consent. There is little known evidence of the effect of the Final Rule in minority enrollment in clinical trials, particularly in traumatic brain injury (TBI) […]

 Clinical Trial Engagement Network

20 Years Later, Drugs Do Act Differently in Women

Mar 31, 2014: By:  Applied Clinical Trials Online: Lisa Henderson In January 2013, FDA told manufacturers to lower the dose of zolpidem for women, and suggested a 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). That was based on evidence the drug is metabolized […]

 Clinical Trial Engagement Network


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