Monday, 24 December 2012

Crowdsourcing brings some festive cheer to MSers

"Some festive cheer! Larry Steinman and colleagues have just been given the green light by the FDA to run an innovative trial of the hypertension drug lisinopril in MS. What is interesting about this trial is that the trial was designed  using novel crowd sourcing software." 

"The company running the trial Transparency Life Sciences, had its Investigational New Drug Application (IND) to assess lisinopril as an adjunctive therapy for MS cleared by the FDA. The trial will use telemonitoring and remote methods for MSer data collection."

Karry Steinman, is the chair of the Scientific Advisory Board, noted, 'Our preclinical data confirms the role of the angiotensin system in the pathology of MS and provides evidence that the ACE inhibitor lisinopril can modulate those effects in target-specific ways. We are delighted that this novel clinical trial protocol has been cleared by the FDA, enabling us to test whether these preclinical findings can translate into a safe and affordable new therapeutic option for MS patients.'


Source: FierceBiotech

"Could this be a way of doing studies of other off-patent drugs? Is this the beginning of the BPA revolution?"

"Happy Holidays"

10 comments:

  1. Being in Stanford/California has many advantages

    A Veru Happy New Year and Happy Holidays to everybody!

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  2. Different times use different methods and technology. So it is just a matter of time before "crowdwhatever" will be the standard.
    At least it is recognized after 20 years.....

    Welcome to here and now.

    Happy holidays!!!

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  3. Can you explain what this actually means, ie how it will work? Or how did the crowd sourcing aspect work? I'm confused!

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    Replies
    1. The company used an internet-based Protocol Builder to ask experts in the field to design the protocol. I started to complete the on-line questionnaire to help with the design, but ran out of time and didn't get back to the task. The important aspect of this initiative is that the time and knowledge given by the experts in designing the protocol was free. Normally a pharma company puts together a steering committee, lies them to a venue and puts them up in a hotel and pays them consultancy fees for the task. This comes at a price. So the crowd-sourcing is much cheaper and I guess quicker.

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    2. Great news G - hopefully this is the way to go. Happy Xmas to you & Team G!

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    3. Perhaps you should write a post on the normal pharma company process.
      It may just reduce some of the criticism you get for accepting consultancy fees, travel costs, hotel costs, etc

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    4. http://www.lawyersandsettlements.com/articles/lisinopril-liver-damage/lisinopril-side-effects-lawsuit-3-17579.html

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  4. Aah thanks for replying - that is indeed good news - and a Happy Christmas and best wishes for 2013 to you and all the team :-)

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  5. http://www.lawyersandsettlements.com/articles/lisinopril-liver-damage/lisinopril-side-effects-lawsuit-3-17579.html another BAD drug yet again

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    Replies
    1. Almost all drugs are associated with side effects and rare adverse events. In short all drugs have risks. Whether or not you take risks depends on the benefits, which is why we need to know the results of the trial.

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