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Posts Tagged "clinical trial"

Molecules to Medicine

UMN agrees to outside review of clinical research practices—but what parts and by whom?

Delivering petition to Gov. Dayton's office-Photo by Jeff Baillon, Fox 9 News

This research ethics series uses the story of Dan Markingson’s participation in a clinical trial of anti-psychotic drugs at the University of Minnesota, his suicide 2004 while participating on the study, and subsequent events as a case study in which to explore various aspects of clinical trial conduct. In previous posts, I’ve looked at issues [...]

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Molecules to Medicine

A Clinical Trial and Suicide: What do the UMN and Disney Have in Common?

Disneys Cinderella castle by Childzy-Wikimedia

This research ethics series uses the story of Dan Markingson’s participation in a clinical trial of anti-psychotic drugs at the University of Minnesota, his suicide 2004 while participating on the study, and subsequent events as a case study in which to explore various aspects of clinical trial conduct. In previous posts, I’ve looked at issues [...]

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Molecules to Medicine

The Checklist Manifesto Meets Clinical Trials–SPIRIT13

ClinicalTrials.gov

ClinicalTrials.gov Atul Gawande has made human lapses more understandable, if not acceptable, reminding us that “We miss stuff. We are inconsistent and unreliable because of the complexity of care,” and making the idea of checklists mainstream, rather than a prop for failing memories. One of the difficulties for any new researcher—and some experienced ones—is designing [...]

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Molecules to Medicine

Covering Clinical Trials: a message for journalists and critical readers

Linnea Duff shows off her "famous lungs" at #ahcj13

My message: Ask the hard questions. The Association of Health Care Journalists annual conference (#ahcj13) covered a variety of topics, with lectures and panels followed by question and answer sessions. As with many conferences, it was tough to choose between competing sessions. I learned a great deal about health care, databases, and resources to help [...]

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Molecules to Medicine

A Clinical Trial and Suicide Leave Many Questions: Part 4: The University of Minnesota’s Response

Bowl of antidepressants

In earlier posts, we’ve looked at issues of consent, investigator responsibilities, and conflicts of interest on the case of Dan Markingson’s suicide while participating in a clinical trial of anti-psychotics at the University of Minnesota. This time, we turn to the University’s response. Not surprisingly, the University has claimed it has no responsibility for any [...]

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Molecules to Medicine

A Clinical Trial and Suicide Leave Many Questions: Part 2: Investigator Responsibilities

Dan Markingson and his mom, Mary Weiss

There are many disturbing things that happened during the clinical trial on which Dan Markingson committed suicide. Besides the issue of consent, or lack thereof, which I raised in my last post, one of the most disturbing aspects to me has been the lack of accountability and the apparent violations of clinical practice standards, with [...]

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Molecules to Medicine

Clinical Trials for Beginners: Recipe for a new drug

Sometimes it seems like new drugs suddenly appear like magic. Have you ever wondered if there was something special going on behind the scenes? Earlier in Clinical Trials for Beginners, we looked briefly at why drug studies came into being, then at how a drug is developed, from test tube to your tissues. Let’s take [...]

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Molecules to Medicine

Lilly’s Shocker, or the Post-Marketing Blues

Just last week, I mentioned that Eli Lilly and Company, as a condition of approval for their blockbuster drug, was required to conduct post-marketing studies of Xigris. Yesterday, Lilly unexpectedly announced the withdrawal Xigris from the market. This was not due to adverse events or side effects, but was the result of exactly such a [...]

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