(Meta)analyze this: Systematic reviews might lose credibility

  Nature.com: September 07, 2012 Doctors and regulatory agencies rely on meta-analyses when setting clinical guidelines and making decisions about drugs. However, as the number of these analyses increases, it’s clear that many of them lack robust evidence from randomized trials, which may lead to the adoption of treatment modalities of ambiguous value. Without a […]

National Medical Device Postmarket Surveillance Plan

Fda.gov: 9/6/12 The mission of FDA’s Center for Devices and Radiological Health (CDRH) is to protect and promote the public health by: 1.) assuring that patients and providers have timely and continued access to safety, effective, and high-quality medical devices and safe radiation-emitting products; 2.) providing consumers, patients, their caregivers and providers with understandable and accessible […]

Ethical Considerations in Studying Drug Safety — The Institute of Medicine Report

Nejm.org: September 12, 2012 The tumult arising from revelations of serious safety risks associated with widely prescribed drugs, including rosiglitazone (Avandia, GlaxoSmithKline), rofecoxib (Vioxx, Merck), and celecoxib (Celebrex, Pfizer), has led to widespread recognition that improvement is needed in our national system of ensuring drug safety. Notwithstanding federal legislation in 2007 that strengthened the authority of […]

Clinical Trial Data as a Public Good

American Medical Association Viewpoint | September 5, 2012 Knowledge of the benefits and risks of prescription drugs is based mainly on published reports of clinical trials, yet the medical literature may present an incomplete and potentially biased sample of clinical trials.1 Trials with positive results generally are published more frequently than studies that conclude that a new drug poses […]

The Safety Risks of Innovation The FDA's Expedited Drug Development Pathway

American Medical Association Viewpoint | September 5, 2012 Driving Biomedical Innovation” is one of the signature initiatives of the Obama Administration and of US Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg’s tenure at the agency.1 This initiative embodies administration policies that government should encourage growth and innovation rather than being the stifling blanket of bureaucracy and delay […]

The “Fairer” Sex: Underrepresentation of Women in Clinical Trials

Triplehelixblog: BY SUCHITA NETY ⋅ SEPTEMBER 3, 2012 Even in the 21st century, women are consistently underrepresented in clinical trials involving drug therapy, medical devices, and behavioral interventions. Although various US federal agencies have made improvements to legislation regarding women’s participation in clinical trials over the past few decades, recent studies demonstrate that the underrepresentation of women remains a persistent […]

Autism research welcomes patients, parents' input

Children’s Hospital trials get $668,000 grant. September 04, 2012|By Paul Jablow, For The Inquirer Jonathan Kratchman, a 16-year-old with autism from Cherry Hill, likes participating in medical research studies. “They explain everything to him,” says his mother, Amy Kratchman. “For once he feels that someone is listening to him. He’s always asking, ‘Mom, when’s the […]

Therapeutic misconception in research subjects: Development and validation of a measure

Ctj.sagepub.com: August 31, 2012 Therapeutic misconception (TM), which occurs when research subjects fail to appreciate the distinction between the imperatives of clinical research and ordinary treatment, may undercut the process of obtaining meaningful consent to clinical research participation. Previous studies have found that TM is widespread, but progress in addressing TM has been stymied by the […]

Researchers Make Clinical Trials a Virtual Reality

ScienceDaily (Aug. 30, 2012) — Clinical trials can be time-consuming, expensive and intrusive, but they are also necessary. Researchers at the University of Tennessee Space Institute in Tullahoma have developed an invention that makes clinical trials more efficient by moving them into the virtual world. Called “digital Eye Bank,” the computer software eye modeling program includes […]

Do Post-Market Drug Trials Need a Higher Dose of Ethics?

Patients who sign up for trials testing more than one already approved intervention do not always know if one is being tested for harmful side effects Scientificamerican.com: By Katherine Harmon, 8/23/12 Say you have high blood pressure. There’s a new blockbuster drug on the market, and your doctor lets you know about a new clinical trial you can join […]

© 2023 National Health Index, LLC. All Rights Reserved.