Saturday, 12 November 2016

Major trials go unpublished

There has been a campaign to get trial data published
Iacobucci G. Nearly half of all trials run by major sponsors in past decade are unpublished. BMJ. 2016 Nov 4;355:i5955. doi: 10.1136/bmj.i5955

The drug company Sanofi has failed to publish results for almost two thirds of the clinical trials it has conducted in the past decade, a major new tracking service has disclosed.
TrialsTracker, a new automated service launched to shine a spotlight on drug companies and universities, found that nearly half of all trials run by major sponsors in the past 10 years were missing results.
1. Sanofi, the multinational drug company based in France, had the highest number of missing results (285 missing results, 65.5% of those conducted). 
The next highest number of missing results was from Novartis Pharmaceuticals (201, 37.6%).
So two companies making some of the MS drugs have not published results.....Surprise, surprise. However academic centres  have fingers pointed at them too.
Chen et al Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ 2016; 352 
Conclusions Despite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centers.

There has been a site set up where you can request data
called clinicalstudydatarequest.com

A number of manufacturers of MS drugs have signed up to data sharing

Novartis is committed to sharing clinical trial data with external researchers and has been doing so voluntarily for several years through its own web portal. The following studies are eligible for data sharing:

1) Phase 2 and Phase 3 studies that are part of the submission package for a new medicine or new indication for regulatory approval of a previously approved medicine in the EU and US as of January 1, 2014. Approval must have been granted by both agencies, unless approval is only sought in either the EU or US.

2) For Phase 2 and Phase 3 studies approved in the EU and US prior to 2014, research proposals requesting data from Novartis will be reviewed on an individual basis and data provided if materially possible (it may not be possible to provide data from studies that are more than ten years old). 

Sanofi Companies* will make clinical trial data available for request:
  • For drugs and biologics:
    • phase II - IV trials in patients sponsored by a Sanofi Company
    • submitted to the US and EU regulatory agencies as part of the request for marketing authorization for new medicines or a new indication for an approved medicine;
    • approved by both agencies on or after January 1, 2014;
      • For new indications, only trials submitted in the application in support of the new indication
    • provided that the trial results have been published
  • Access to data from trials listed as available on the site is determined by the Independent Review Panel based on the scientific merit of the research proposal. In exceptional circumstances, access to data may be declined by the sponsor, for example, where there is a potential conflict of interest or an actual or potential competitive risk.
Roche
All phase 2 and 3 clinical studies or phase 4 studies that were used as part of a regulatory approval or where the product was terminated from development (all indications) with a first patient enrolled as of 1 January 1999 onwards. 

Roche is in the process of compiling a list of studies in scope. Roche will regularly update this list to add studies going back to January 1999. In the event that you cannot see a specific study in the Roche list, an Enquiry Form can be submitted to confirm the availability of the specific study.

So this is all interesting. We have made requests, let's see if we get anywhere, one has been turned down as being out of scope....Are they hiding a failure or worse a worsening? 

I'll let you know what was requested in a bit.

2 comments:

  1. Thank you, MouseDoctor. You are doing you research job here and I hope you'll find the truth. One would think that they were required by law to show all their cards...( the good, the bad and the ugly)

    ReplyDelete
    Replies
    1. Sadly no and I can tell you already... I have found the ugly!

      Delete

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