Tuesday, 17 June 2014

Putting Trial data in the open

Pharma is often accused and shown to be cooking the books when it comes to the results of clinical trials. For this reason there has been a move to make Pharma release primary data of clinical trials studies such that it can be effectively interrogated and shown to be right. Pharma are now spending loads getting the data in a shape that allows this.  They need to re-dact the studies to get rid of patient identification and need to present data is a standard format so it can be analysed. This is coming as the European Medical Agency indicated, but Pharma is dragging its feet.

Likewise this is coming for scientists also. For example PLOSOne requires authors to agree to make primary data available. 


May be they need to publish their old data and we can see if they have been telling porkies for may years, pharma has been caught out many times.

5 comments:

  1. Mouse Doc, I think you will find that Big Pharma are lobbying hard and the EMA appears to be bowing to the pressure and this is unlikely to occur.

    http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/News/Is-EMA-Back-Tracking-on-Open-Data-Promises/ArticleStandard/Article/detail/843701

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    1. I agree but amendments were tabled this week end to remove the on-screen only access to allow download and save. There is no point in having access to data if it is not in a usable format.

      Can we get access to trial data maybe we need to try them out.

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  2. Who could guarantee they will not manipulate the data the way they want

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    1. In the age of computers and clinical trials every time you change a document the changed document and the previous document is recorded.This is transparent and is part of the reqjired data handling
      It would take alot to doctor stuff and it would be transparent. Easier to restrict access than doctor. In clinical trials.gov all changes are logged but it still doesnt stop pharma changing primary endpoints AFTER the trail is finished but it is transparent if you know where to look.

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    2. Every file carries a date and time it was created

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