FDA: Use Sicker Patients in Clinical Trials
Medpagetoday: Feb 1, 2014 WASHINGTON — The FDA is taking steps to include more patients with multiple chronic conditions in clinical trials of new drugs, believing such patients are too frequently excluded from new drug studies. Pharmaceutical companies routinely exclude the sickest patients from studies, fearing complications they may suffer from the drug candidates, but, as […]
Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
JAMA: 1/22/14 Importance Many patients and physicians assume that the safety and effectiveness of newly approved therapeutic agents is well understood; however, the strength of the clinical trial evidence supporting approval decisions by the US Food and Drug Administration (FDA) has not been evaluated. Objectives To characterize pivotal efficacy trials (clinical trials that serve as the basis of […]
A Systematic Review of Barriers and Facilitators to Minority Research Participation Among African Americans, Latinos, Asian Americans, and Pacific Islanders
American Journal of Public Health: Sep 21, 2013 Sheba George is with the Center for Biomedical Informatics, Charles R. Drew University of Medicine and Science, and the Department of Community Health Sciences, University of California Los Angeles (UCLA) Fielding School of Public Health, Los Angeles. Nelida Duran is with the Department of Community Health Sciences, UCLA […]
Managing Incidental Genomic Findings in Clinical Trials: Fulfillment of the Principle of Justice
PLOS: January 14, 2014 Three basic principles are key in assessing the ethics of any research conducted on humans: respect for persons (or autonomy), beneficence, and justice [1]. Respect for persons entails individuals being afforded the right to decide what should happen to them; this principle is fulfilled through a valid informed consent process. Research participants should […]
Join the “I’m In” Campaign to Support Clinical Trial Research
I’m In is a campaign launched by the Pharmaceutical Research and Manufacturers of America (PhRMA), National Minority Quality Forum and Microsoft to improve health by increasing clinical trial participation among traditionally underrepresented populations. I’m In makes this possible through our secure online Clinical Trial Engagement Network. The network connects the volunteer to clinical trials in which they may be […]
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2014 11th Annual Health Disparities Leadership Summit & Awards Dinner
REGISTRATION IS NOW OPEN: The 2014 CBC Spring Health Braintrust and National Minority Quality Forum 11th Annual Health Disparities Leadership Summit & Awards Dinner April 28 & 29, 2014 Ritz-Carlton Hotel Washington, DC The National Minority Quality Forum and the Congressional Black Caucus Foundation, Inc., in collaboration with the Congressional Black Caucus Braintrust, are collaborating […]