5 Surprising Facts about Clinical Trials
PACE: 03/13/14 Perception poses a huge barrier when it comes to clinical trial participation. While trials remain vital to progress against cancer, less than 5% of U.S. cancer patients enroll in them, due in part to misinformation surrounding the process. Though 71% of Americans agree on the importance of clinical trials, many remain hesitant to participate. In order […]
National Campaign Launched To Help Increase Diversity In Clinical Trials
Prnewswire: 3/12/14 I’m In campaign to educate underrepresented populations about clinical trial participation WASHINGTON, March 12, 2014 /PRNewswire/ — The Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Minority Quality Forum today announced a first-of-its-kind national campaign to help increase diversity in clinical trials. The I’m In campaign will raise awareness about the importance of clinical research and […]
Patient engagement in research: a systematic review
Biomedcentral: 2/26/14 A compelling ethical rationale supports patient engagement in healthcare research. It is also assumed that patient engagement will lead to research findings that are more pertinent to patients’ concerns and dilemmas. However; it is unclear how to best conduct this process. In this systematic review we aimed to answer 4 key questions: what are […]
Sex-Specific Medical Research Why Women’s Health Can’t Wait
Brigham and Women’s Hospital: 2/26/14 A Report of the Mary Horrigan Connors Center for Women’s Health & Gender Biology at Brigham and Women’s Hospital Twenty years ago, a bipartisan group of legislators worked with patients, providers, policy makers, and advocates to create and pass the 1993 National Institutes of Health Revitalization Act, a law mandating […]
A Proposal for Integrated Efficacy-to-Effectiveness (E2E) Clinical Trials
Clinical Pharmacology & Therapeutics: 12/4/14 We propose an “efficacy-to-effectiveness” (E2E) clinical trial design, in which an effectiveness trial would commence seamlessly upon completion of the efficacy trial.Efficacy trials use inclusion/exclusion criteria to produce relatively homogeneous samples of participants with the target condition, conducted in settings that foster adherence to rigorous clinical protocols. Effectiveness trials use inclusion/exclusion criteria that generate […]
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 […]
