Minorityhealth.hhs.gov: National Partnership for Action, Posted on 4/11/2012 by Irena McClain. Irena McClain is the Associate Director at the Diabetes Foundation of Mississippi (DFM). She joined the staff in 1994 and is active in the Minority Health Initiative and “Sweet Subject” School Diabetes Education programs at the DFM. She received an AB in Biology from Smith College and […]
Ema.europa.eu, 16/04/2012. European Medicines Agency publishes reflection paper with practical guidance on the assurance of ethical and GCP standards in the conduct of clinical trials included in marketing authorisation applications submitted in the EU The European Medicines Agency today published the final reflection paper on ethical and good clinical practice (GCP) aspects of clinical trials of […]
Nihrecord.od.nih.gov: By Carla Garnett, April 13, 2012. We need to rethink the clinical trials system—from the ground up. That’s what Dr. Robert Califf proposed at a recent Mind the Gap seminar, “Innovative Approaches to Clinical Trials.” “I hope to convince you that incremental changes in our clinical trials system will not be sufficient,” he said. “We […]
Establishing an Agenda for 2020 – Workshop Summary Released: April 13, 2012 Type: Workshop Summary Topic: Biomedical and Health Research Activity: Forum on Drug Discovery, Development, and Translation Board: Board on Health Sciences Policy. There is growing recognition that the United States’ clinical trials enterprise (CTE) faces great challenges. There is a gap between what […]
Policymed: April 11, 2012. On April 28, 2008, the Food and Drug Administration (FDA) amended its regulations on the acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (“non-IND foreign clinical studies”) as support for an IND or a new drug application (NDA), abbreviated new drug application (ANDA), or a biologics […]
Why Trial Data Should Be Open for All Citation: Eichler H-G, Abadie E, Breckenridge A, Leufkens H, Rasi G (2012) Open Clinical Trial Data for All? A View from Regulators. PLoS Med 9(4): e1001202. doi:10.1371/journal.pmed.1001202 Plosmedicine.org: Published: April 10, 2012 First and foremost, we agree with Doshi et al. that clinical trial data should not be considered commercial confidential information; […]
Chron.com: By Todd Ackerman, Monday, April 9, 2012. Texas’ proposed adult stem-cell regulations, up for approval this week, are under fire for circumventing the Food and Drug Administration and making the experimental therapy commercially available before it’s been proven safe and effective. The criticism of the Texas Medical Board draft policy, developed in the aftermath of Gov. Rick Perry receiving stem-cell treatment for his […]
A vaccine that can train cancer patients’ own bodies to seek out and destroy tumour cells has been developed by scientists. Telegraph.co.uk: By Richard Gray, Science Correspondent, 8:00AM BST 08 Apr 2012. The therapy, which targets a molecule found in 90 per cent of all cancers, could provide a universal injection that allows patients’ immune systems to fight off […]
Theconversation.edu.au: April 6, 2012, 8.36am. TRANSPARENCY AND MEDICINE – A series examining issues from ethics to the evidence in evidence-based medicine, the influence of medical journals to the role of Big Pharma in our present and future health. Here Ian Haines makes an argument for research data from published papers to be made public. It’s […]
Newswise.com: Released: 4/6/2012 10:45 AM EDT Source: University of Pennsylvania School of Nursing Newswise — In one of the first studies of its kind,University of Pennsylvania School of Nursingresearchers have identified what cancer patients consider the “benefits and burdens” of participating in clinical research trials. From their findings, the researchers developed a model of the five elements of […]
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