Developing a guideline for clinical trial protocol content: Delphi consensus survey

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Trialsjournal.com: September 24, 2012 Recent evidence has highlighted deficiencies in clinical trial protocols, having implications for many groups. Existing guidelines for randomized clinical trial (RCT) protocol content vary substantially and most do not describe systematic methodology for their development. As one of three prespecified steps for the systematic development of a guideline for trial protocol content, […]

A theoretical framework for early human studies: uncertainty, intervention ensembles, and boundaries

Trialsjournal.com: Jonathan Kimmelman, September 2012 Clinical development of novel therapeutics begins with a coordinated sequence of early phase clinical trials. Such early human studies confront a series of methodological and ethical challenges. In what follows, I propose a theoretical framework for early human studies aimed at informing the negotiation of these challenges. At the outset of clinical […]

A Randomized Study of How Physicians Interpret Research Funding Disclosures

Nejm.org: 9/20/12 The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians’ reactions to trials with a high, medium, or low level of methodologic rigor. We presented 503 board-certified internists with abstracts that we designed describing clinical trials of three hypothetical drugs. The trials had […]

Ten Pharmaceutical Companies Unite to Accelerate Development of New Medicines

Pharmalive.com: New Non-Profit Organization to Speed Pharmaceutical R&D, 9/19/12 PHILADELPHIA, Sept. 19, 2012 /PRNewswire/ — Ten leading biopharmaceutical companies announced today that they have formed a non-profit organization to accelerate the development of new medicines. Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, […]

Assessing an Intervention to Improve Clinical Trial Perceptions Among Predominately African-American Communities in South Carolina

Project MUSE: Volume 6, Issue 3, Fall 2012 African Americans (AA) are not well-represented in cancer clinical trials despite having significantly higher cancer mortality rates than their European-American (EA) counterparts. Objectives: The purpose of this study was to evaluate a program to improve perceptions of cancer clinical trials among AA. Methods: The program was conducted in a convenience […]

Millions of seniors enrolled in some of the most popular Medicare prescription drug plans face double-digit premium hikes

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By Ricardo Alonso Zaldivar on September 25, 2012. WASHINGTON (AP) — Millions of seniors enrolled in some of the most popular Medicare prescription drug plans face double-digit premium hikes next year if they don’t shop for a better deal, says a private firm that analyzes the highly competitive market. Seven of the top 10 prescription […]

Through the Affordable Care Act, Americans with Medicare will save $5,000 through 2022

HHS.gov: September 21, 2012 5.5 million seniors saved money on prescription drugs and 19 million got free preventive care in 2012 Because of the health care law – the Affordable Care Act – the average person with traditional Medicare will save $5,000 from 2010 to 2022, according to a report today from the U.S. Department of […]

Medicare Bills Rise as Records Turn Electronic

Nytimes.com: By REED ABELSON, JULIE CRESWELL and GRIFF PALMER. Published: September 21, 2012 When the federal government began providing billions of dollars in incentives to push hospitals and physicians to use electronic medical and billing records, the goal was not only to improve efficiency and patient safety, but also to reduce health care costs. But, in reality, the move to electronic […]

New Year to Bring New Medicare Taxes, Raise Money for the Program

Medicarenewsgroup.com: September 20, 2012. Medicare finances are already complex, but 2013 will bring a new and confusing tax burden on wealthier Americans. This is because of a change in the payroll tax rate and a new surtax on investments. The combined new payroll tax and surtax is expected to raise $210 billion over a 10-year period. […]

Medicare Advantage remains strong

Hhs.gov: September 19, 2012 Enrollment in the Medicare Advantage (MA) program is projected to increase by 11 percent in the next year and premiums will remain steady, Health and Human Services Secretary Kathleen Sebelius announced today. Since the Affordable Care Act was passed in 2010, Medicare Advantage premiums have fallen by 10 percent and enrollment has […]

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