foxhole conversions…

Posted on Wednesday 6 February 2013

We are pleased to sign up to the AllTrials campaign for clinical trial transparency and support its call for the registration of clinical trials and the disclosure of clinical trial results and clinical study reports. At GSK, we are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment. We already publicly disclose a significant amount of information about our clinical trials. We register and post summary information about each trial we begin and share the results of all our clinical trials – whether positive or negative – on a website accessible to all. Today this website includes almost 5,000 clinical trial result summaries and receives an average of almost 11,000 visitors each month. We have also previously committed to seek publication of the results of all of our clinical trials that evaluate our medicines to peer-reviewed scientific journals.

Expanding on this, we have committed to make CSRs publicly available through our clinical trials register. From now, we will publish CSRs for all of our medicines once they have been approved or discontinued from development and the results have been published. This is to allow for the data to be first reviewed by regulators and the scientific community. Patient data in the CSRs and their appendices will be removed to ensure patient confidentiality is maintained.

In addition, while there are practical challenges, we also intend to publish CSRs for clinical outcomes trials for all approved medicines dating back to the formation of GSK. This will require retrieval and examination of each historic CSR to remove confidential patient information. Given the significant volume of studies involved, we will put in place a dedicated team to conduct this work which we expect to complete over a number of years. Posting will take place in a step-wise manner, with priority given to CSRs for its most commonly prescribed medicines. Separately, we are also working to develop a system where researchers will be able request access to detailed anonymised patient level data that sit behind the results of our clinical trials to enable additional scientific inquiry and analyses to help further scientific knowledge.

Press coverage:
Foxhole conversions are better than no conversions at all, I always say. Why, I’ll bet they’ll be thinking about suggesting Paxil Study 329 and Paxil Study 352 should be retracted from the literature soon. Unlikely? If you told me this time last year that GSK would sign a petition calling for full data transparency in Clinical Trials, I’d have recommended a full competency evaluation at your earliest convenience…
  1.  
    February 6, 2013 | 10:58 PM
     

    Throwing Paxil Study 329 and Paxil Study 352 under the bus would be a brilliant PR move.

    I’m sure there are a hundred ways to appear to cooperate with AllTrials but somehow not fully comply.

  2.  
    February 6, 2013 | 11:04 PM
     

    Yes, we’ve come by our suspicious minds honestly.
    I will say that their posted data on Paxil Study 329 was fine [if only 11 years late!]…

  3.  
    Annonymous
    February 6, 2013 | 11:24 PM
     

    http://www.forbes.com/sites/larryhusten/2013/02/01/no-sunshine-for-continuing-medical-education/

    http://www.theatlantic.com/health/archive/2013/02/what-the-sunshine-act-means-for-health-care-transparency/272926/

    http://pharmagossip.blogspot.com/2013/02/let-sun-shine-in-contd.html

    http://www.pharmalot.com/2013/02/no-sunshine-on-continuing-medical-education/

    “There is at least one exception to the the reporting requirements – manufacturers and GPO’s are not required to report ownership or investment intereste held by teaching hospitals.”

    http://www.pharmalot.com/2013/02/let-the-sunshine-in-cms-releases-transparency-rule/

    Teaching hospitals, i.e. Academic Centers, which run a lot of CME, can both not reveal their stakes in the products and can also launder money to KOLs.

    So, two enormous exceptions put in by the Obama administration. This is what a progressive agenda looks like? What is the term Goldacre uses? Failed fixes. How disappointing.

  4.  
    Annonymous
    February 6, 2013 | 11:26 PM
     
  5.  
    berit bj
    February 7, 2013 | 11:01 AM
     

    GSK’s record of criminal fraud and deceit is on par with Big Pharma, generally, globally, the fines of 3 bn dollars just rising costs of doing business. Loss of trust is another matter, particularly with European politicians poised to vote on motions tabled to enforce strickter regulations. How strickt is the question.
    So GSK says it will mend its ways, aiming for a conservative majority to enact the least strict measures in the EU. It will be interesting to see if MEP Ms Glenis Willmott manages to get the necessary votes in support of progressive proposals, against the organized army of pharma lobbyists

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