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Posts Tagged "Clinical Trials for Beginners"

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

A Clinical Trial and Suicide Leave Many Questions: Part 5: The Case of the Mysteriously Appearing Documents

This series uses the story of Dan Markingson’s participation in a clinical trial of anti-psychotics at the University of Minnesota, his ultimate suicide 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, we’ve looked at issues of “good clinical [...]

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Molecules to Medicine

Drug screens-any more than theater?

I’ve been doing a lot of traveling recently, and am increasingly disturbed by the growing surveillance society and the misplaced reassurances that are used to assuage the public, coined “security theater” by Bruce Schneier. Here we’ll look at this drama in the context of screening for drugs of abuse. In a later post we’ll look [...]

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Molecules to Medicine

A Clinical Trial and Suicide Leave Many Questions: Part 3: Conflict of Interest

We’ve touched on some of the many disturbing things that happened during the clinical trial on which Dan Markingson committed suicide. In my first post, I asked how a psychotic, homicidal patient who was involuntarily hospitalized in a psychiatric hospital could give an informed consent for participation in a clinical trial. There appeared to have [...]

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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

A Clinical Trial and Suicide Leave Many Questions: Part 1: Consent?

Dan and his mom, Mary Weiss

  The suicide of Dan Markingson, a 26 year old man participating in a psychiatric trial, has again made the news, and will serve us for a life-time of study and discussion of research ethics, along with the TeGenero and Jesse Gelsinger cases.   Markingson began to show signs of paranoia and delusions in 2003, [...]

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Molecules to Medicine

Molecules to Medicine: From Test-Tube to Medicine Chest

We looked briefly at why drug studies came into being; now let’s look at how a drug is developed, from test tube to your tissues. Every government approved drug goes through the same sequence of testing anywhere in the world. In the US, this is done under the supervision of the FDA, and is conducted [...]

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Molecules to Medicine

Molecules to Medicine: Clinical Trials for Beginners

Have you ever wondered about the medicines you take—how they are developed and produced? We’ll explore that in “Molecules to Medicine.” This new series could be described as “medicine for muggles,” intended to take the mystery out of clinical research and drug development and to provide background information so that both patients and physicians can [...]

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