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) […]
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 […]
Supplement: Enhancing minority participation in clinical trials (EMPaCT): Laying the Groundwork for Improving Minority Clinical Trial Accrual
Wiley: April 1, 2014 An overview of EMPaCT and fundamental issues affecting minority participation in cancer clinical trials: Enhancing minority participation in clinical trials (EMPaCT): Laying the groundwork for improving minority clinical trial accrual (pages 1087–1090)Selwyn M. Vickers and Mona N. FouadArticle first published online: 18 MAR 2014 | DOI: 10.1002/cncr.28569 This supplement provides an overview of […]
What steps can we take to increase patient participation in clinical trials, particularly among diverse populations?
Gary Puckrein, President and CEO of the National Minority Quality Forum, discusses the importance of diversity in clinical trials at the launch of the new I’m In campaign to increase the number of minority participants in clinical trials. One of the great challenges that we face right now is to get greater diversity […]
Nationwide effort aims for more diversity in clinical drug trials
JN: 3/16/14 Thousands of volunteers participate in clinical trials across the United States each year, all hoping that the experimental treatment will help ease their pain or cure their disease. While the trials target a host of different ailments, there is one thing most of those patients have in common. The vast majority are white, […]
Prevalence, Characteristics, and Publication of Discontinued Randomized Trials
JAMA: 3/12/14 Importance The discontinuation of randomized clinical trials (RCTs) raises ethical concerns and often wastes scarce research resources. The epidemiology of discontinued RCTs, however, remains unclear. Objectives To determine the prevalence, characteristics, and publication history of discontinued RCTs and to investigate factors associated with RCT discontinuation due to poor recruitment and with nonpublication. Design and Setting Retrospective […]
HHS establishes new network to perform clinical studies
HHS: March 11, 2014 Network can prepare, conduct clinical studies for drugs to protect health in emergencies HHS today established a network of five clinical research organizations that will design and conduct clinical studies needed to develop medical countermeasures – drugs, vaccines, and diagnostic tests that help protect health against bioterrorism, pandemic influenza, and other public […]