Publication of Pivotal Efficacy Trials for Novel Therapeutic Agents Approved Between 2005 and 2011
JAMA: July 28, 2014 Pivotal efficacy trials, which are trials that form the basis of the US Food and Drug Administration’s (FDA) decision to approve a novel therapeutic agent,1 have great relevance to clinical practice because when these therapies are first approved for use, few clinical trials have been conducted. However, studies focused on pharmacotherapies approved prior to 2005 […]
Accumulating Research: A Systematic Account of How Cumulative Meta-Analyses Would Have Provided Knowledge, Improved Health, Reduced Harm and Saved Resources
PLOS: July 28, 2014 Abstract Background “Cumulative meta-analysis” describes a statistical procedure to calculate, retrospectively, summary estimates from the results of similar trials every time the results of a further trial in the series had become available. In the early 1990s, comparisons of cumulative meta-analyses of treatments for myocardial infarction with advice promulgated through medical textbooks […]
Biopharmaceutical Industry Committed to Discovery and Development of New Therapies for Patients Despite Challenges
Pharma: 07.25.14 Mental health conditions affect 1 in 4 Americans and take a heavy economic toll on the United States. Efforts to find effective treatments for conditions such as anxiety, depression, schizophrenia and substance abuse disorders continue despite difficult hurdles and setbacks. Researchers face a number of challenges in finding new treatments for mental illnesses — including […]
FDA Sentinel: Catching Biopharmaceutical Sponsors by Surprise
Applied Clinical Trials Online: Jul 24, 2014 The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects. During an update on The Future of FDA’s Drug Safety Program,Andrew C. von Eschenbach stated, “The full magnitude of some potential […]
Outdated Regulations Prohibit Sharing of Scientifically Accurate Information to the Detriment of Patient Care
Phrma: 07.22.14 In May, the U.S. House Energy and Commerce Committee launched the 21st Century Cures initiative to speed the discovery, development, and delivery of new treatments and cures for patients. The Committee is conducting a series of hearings and has released white papers on a range of topics to solicit input from patients, researchers, and leaders in government and […]
African American Women’s Perceptions and Attitudes Regarding Participation in Medical Research: The Mayo Clinic/The Links, Incorporated Partnership
Journal of Women’s Health: July 21, 2014 Objective: To examine perceptions and attitudes toward health-related research participation among professional African American women. Methods: Participants were members of an African American women’s service organization, The Links, Incorporated. Data were collected via self-administered questionnaires at The Links, Incorporated 2012 National Assembly. Sociodemographics, prior research experience, intention to participate (ITP), […]
Medical Research: It’s about you and me
Research America: July 21, 2014 Research!America’s newest fact sheet series highlights the personal stories of medical research and the importance of increasing the NIH budget in FY15. We hope you will share these fact sheets with your representatives or congressional candidates, or take it with you on Hill or in-district visits. No one who reads […]
