TAG ARCHIVES FOR clinical trials

28
Aug2015

Modernizing Biomedical Innovation: Understanding the 21st Century Cures Act

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28 Aug
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On July 10, 2015, the US House of Representatives passed H.R. 6, the 21st Century Cures Act, with a vote of 344-77. The passage of the bill, which many have hailed as a noteworthy example of bipartisan collaboration, is the result of more than a year of congressional hearings, roundtable discussions, whitepapers, and political debate. First introduced in April 2014 by Fred Upton (R-MI), chairman of the US House of Representatives’ Energy and Commerce Committee, and Representative Diana DeGette (D-CO), the 21st Century Cures initiative seeks to "accelerate the pace of cures in America."

The legislative phase of the 21st [...] Read more

10
Apr2015

Research Ethics Roundup: The Ethics of Neuroscience Research, Facebook and Research, and more

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10 Apr
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In this week's Research Ethics Roundup, we explore some of the ethical and practical questions posed by new innovations in the research enterprise, as well as some age old concerns, such as the recruitment of subjects for clinical trials. Read on:

FDA, Sponsors Look to Expand Patient Input to Clinical Trials: The involvement of patient groups in the design of clinical trials is becoming increasingly common. In this article for Applied Clinical Trials, Jill Wechsler reports on this shift, as well as the Food and Drug Administration's efforts to foster patient-focused drug development.

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16
Mar2015

The Little Things DO Mean A Lot: Lessons from AER14 Continue to Resonate

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16 Mar
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by Krystal Bradford, CIP, research compliance specialist at Cincinnati Children’s Hospital Medical Center

Since my last blog post, I have tried to pay closer attention to things discussed at the 2014 AER Conference that I have incorporated into my everyday work. Several items that stand out to me might be considered minor, but there is payoff in the end. One example is documentation.
If you have read any post-site visit letters from OHRP or FDA, there is almost always a reference to documentation that should have occurred but didn’t. Accurate research study [...] Read more

14
Jul2014

Research Ethics Roundup: Facebook’s unethical experiment, FDA’s support for marijuana clinical trials, and more

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14 Jul
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Perhaps you’ve already read – on your Facebook News Feed, no doubt – about Facebook’s recent mood experiment. Not to worry—this post has no hidden motive. We’re just pleased to be able to share recent headlines from around the research ethics world with you.

Everything We Know about Facebook’s Secret Mood Manipulation Experiment: Following the publication of a paper in the Proceedings of the National Academy of Sciences, [...] Read more