"Fixing our Medicine: Why All Clinical Trials Need to be Published”

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"Fixing our Medicine: Why All Clinical Trials Need to be Published”

Post by hardindr » Mon Feb 15, 2016 1:56 pm

"Fixing our Medicine: Why All Clinical Trials Need to be Published”

Presentation by Lauren Quattrochi, Ph.D, Director of AllTrials USA at Sense About Science



Twitter hashtag #AllTrials

Sponsored by CNY Skeptics and TACNY

Time: Wednesday, March 16, 2016, 6:00 PM

Where: SUNY-OCC, Room W101, Whitney Applied Technology Center, 4585 West Seneca Turnpike, Syracuse, NY 13215

Event is Free and Open to the Public

Please contact 1-315-636-6533 or email info@cnyskeptics.org for more information

Presentation Summary:

Only half of all clinical trials globally have reported results. Dr. Quattrochi will describe the current landscape for publication bias and how this lack of clinical trial transparency has shaped our medicine. She will dive into why withheld clinical trial data may hold valuable insight into progressing our medical system by touching on cases where unpublished or poorly published clinical trial data has negatively impacted patients, the medical community and/or fellow pharmaceutical researchers. Thereafter, she will detail how the AllTrials campaign aims to address and rejuvenate scientific data sharing on a global level.

Presenter Bio:

Dr. Lauren Quattrochi is a neuroscientist who guides the campaign for AllTrials USA at Sense About Science USA, a non-profit focused on equipping the public with tools and knowhow to navigate evidence-based research. She specializes in educating the public on breakthrough science, correcting popularized pseudoscience and bringing about awareness on clinical trial transparency in the USA. She earned her doctorate from Brown University in Molecular Pharmacology and Physiology, where she discovered a novel third subtype of photoreceptor.

Central New York Skeptics (CNY Skeptics) is a community organization dedicated to the promotion of science and reason, the investigation of paranormal and fringe-science claims, and the improvement of standards for science education and critical-thinking skills.

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Re: "Fixing our Medicine: Why All Clinical Trials Need to be Published”

Post by ElectricMonk » Mon Feb 15, 2016 2:10 pm

Because of their limits in size and time, clinical trials will never be sufficient.
What we need is post-approval monitoring of drugs and procedures, and a mandatory 'sunset'-provision unless the gathered data shows sufficient benefits.

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Re: "Fixing our Medicine: Why All Clinical Trials Need to be Published”

Post by Pyrrho » Mon Feb 15, 2016 2:21 pm

FDA does require postmarket surveillance and does have an adverse event reporting system. Numerous drugs have received "black box warning" requirements and many have been taken off the market because of adverse effects identified after those drugs had been on the market.

http://www.fda.gov/Drugs/GuidanceCompli ... 090385.htm

Despite CDER's vigilant premarket review, active postmarketing surveillance of drug adverse effects is also essential. Because all possible side effects of a drug can't be anticipated based on preapproval studies involving only several hundred to several thousand patients, FDA maintains a system of postmarketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug approval process. FDA monitors adverse events such as adverse reactions and poisonings. The Agency uses this information to update drug labeling, and, on rare occasions, to reevaluate the approval or marketing decision.
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Re: "Fixing our Medicine: Why All Clinical Trials Need to be Published”

Post by zeuzzz » Tue Mar 08, 2016 6:34 pm

I would guess that the "Only half of all clinical trials globally have reported results" is a gross underestimate.

It's common business sense for a profit based corporation in competition, if you are a pharmaceutical company and you make 20 billion a year from prescribing psychotropic drugs that cure say depression or anxiety, and you study a natural plant that has a greater efficacy with less side effects that anyone can grow, there is not a chance in hell that study would see the light of day or be followed up with further funding. What is not patented is prohibited: that's an unfortunate truism of the current capitalist medical establishment.

I can highly recommend this book by Ben Goldacre. Bad Pharma: How Medicine is Broken, and How We Can Fix It http://www.amazon.co.uk/Bad-Pharma-How- ... 000749808X
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