Archive for August, 2009

Do subjects want to know about conflicts of interest? Not necessarily

Icon Written by Alex on August 28, 2009 – 11:08 am

An article in Scientific American states that “patients” in clinical trials would prefer to be informed if researchers in their clinical trial have a financial conflict of interest in the outcome of the research. The premise, however, that subjects are eager for such disclosure, is not necssarily true and might actually be false.

Swine flu vaccine testing in new, exciting and potentially dangerous ways

Icon Written by Alex on August 26, 2009 – 8:32 am

Swine flu – or the H1N1 influenza pandemic – is THE story in clinical trials and in medicine right now. It looks to continue to be the object of intense focus and fascination until at least the winter, when the flu is expected to either impact millions of people or be blunted by the distribution of a vaccine. It is the vaccine, of course, that is now under clinical trials testing. However, the trials are being conducted in an interesting way that involves first producing the vaccine and filling the vials for shipment before the trials are finished. This poses significant risks yet also carries the possibility for great success in stemming the spread of the flu, depending on how things go.

The story below is a good overview of things right now. I will keep updating events as they move forward. Let me know what you think.

Washington Diplomat Talks About Chasing Medical Miracles

Icon Written by Alex on August 11, 2009 – 1:24 pm

In an article called Trial and Error, Washington Diplomat magazine talks about Chasing Medical Miracles (including a sidebar) in its August issue. The article by Gina Shaw is a nice look at the overall topic. Seeing how “the Washington Diplomat is an independent monthly newspaper with a readership of more than 100,000… distributed to all Washington-based foreign embassies, the United Nations in New York, the World Bank and IMF Group, the U.S. State Department, Capitol Hill, the White House and many other points of influence within the greater metropolitan area,” here’s hoping clinical trials will come to the close attention of those who can examine and maybe even improve how they function.

Clinical trials’ red tape focus of Op Ed in NYT

Icon Written by Alex on August 9, 2009 – 9:20 am

Researchers involved in clinical trials are being so choked by bureaucratic red tape that their research is suffering, according to Sally Satel, a scholar at the American Enterprise Institute in an op-ed piece in Friday’s New York Times. Satel’s insights are valuable because they point out that thickets of regulations often don’t protect subjects. She however misses the larger point that the red tape and lack of subject protection in what she in the article refers to as the “dysfunctional system” of clinical trials is due mostly to their explosive growth and commodification in the last decade.

Turning down trials, cool apps, and swine flu

Icon Written by Alex on August 7, 2009 – 8:24 am

Some really fascinating stories get us going into the weekend. Interesting and heartfelt responses to NYT article about cancer trials and why people don’t volunteer for trials… although I’m not convinced of their necessity at all, very cool story about iphone and Windows apps for clinical trials … and an update on efforts in the U.S. and abroad about progress on trials for a swine flu vaccine…

Why Patients Turn Down Clinical Trials – New York Times – I read with interest your article about the chilling effect that low recruitment for clinical trials has had on the search for meaningful treatments.

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New York Times & Parade Champion Clinical Trials

Icon Written by Alex on August 3, 2009 – 8:03 am

The New York Times has a story about cancer trials that subtly urges patients to enroll as subjects. There is also a sidebar about how to make the decision to enroll. Al in all, a pro-trials approach, which is becoming all too common in most media coverage of trials at the same time that corporate interests assert themselves … Also, a story from a recent Parade magazine urging people to, you guessed, it, enroll in trials. This one is done is such a strenuously blatantly fashion that the subhead is: “Sometimes it take an experiment to make you well.”

Forty Years’ War Lack of Study Participants Said to Hobble Fight … New York Times – Of course, there have been highly successful clinical trials…

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