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Will Europe's Drive for Clinical Transparency Stifle Innovation?

Bikash Chatterjee, President & CTO, Pharmatech Associates
Monday, February 25, 2013 00:01 EST

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mdmconsult
mdmconsult  
5/14/2013 1:44:05 PM
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Re: Lessons in Transparency from GSK

Glaxo-SmithKline is making good efforts to ensure researchers information with the company's site and handling transparency. Also its R&D expenditures are beginning to embrace a new approach. Pressure with success in pharmaceutical companies won't be completely forthright about the risks of their programs. To build trust, management teams must therefore support thorough due diligence, just as they would expect it themselves. They'll also have to explain their motives for wanting to share particular risks from such lessons.

 


Agnes Shanley
Agnes Shanley  
5/14/2013 1:15:49 PM
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Re: Lessons in Transparency from GSK
GSK recently launched a web site that will allow authorized researchers access to clinical trials data, offering the industry a potential example for handling the transparency issue. More on this, from Fierce Biotech IT (courtesy of DIA LinkedIn Group!)

Bikash Chatterjee
Bikash Chatterjee  
3/28/2013 4:24:03 PM
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Re: Transparency
 

This was a great link Agnes! The discussion I think crystallizes dilemma before the industry and the public. What I found encouraging was the concept of having data reviewed and analyzed by independent third party groups such as the Chochrane Collaboration which follows a rigorous protocol for analysis and distillation of any clinical data. The danger as I see it is the potential for misinterpretation of early clinical trials such as Proof-f-Concept trials and Phase 1 trials. In some organizations these trials are barely powered to support a definitive endpoint , and if the data were to be reviewed without considering the statistical power it would be easy to imagine a physician misinterpreting the data. Despite Whitehead's defensiveness I do believe he has hit the nail on the head when he said the issue is the "how we do it" versus "if we do it". The direction in Europe is clear. It will be interesting to see how broadly the grassroots movement takes off on our side of the pond.

Agnes Shanley
Agnes Shanley  
3/8/2013 6:46:14 PM
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Re: Transparency
A few days after Bikash's post was published, there was an interesting debate, sponsored by PharmaTimes at the Royal Institution, between Ben Goldacre, author of Bad Science and Bad Pharma, and Stephen Whitehead, CEO of the Association of British Pharma Industry.  Apparently it was captured on video, but I could not find anything online.  However, the event was summarized in PharmaTimes, which also ran a reader poll.  

Barry Langdon
Barry Langdon  
3/6/2013 5:14:45 AM
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Re: Transparency
As long as everybody plays fair and publishes this data, this could become a give and take, mutually beneficial process

Bikash Chatterjee
Bikash Chatterjee  
3/6/2013 2:18:53 AM
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Re: Transparency
 

There is no doubt on a philosophical level that this is a good thing for patients but the implementation is fraught with land mines. Take for instance the recent announcement by the British Journal of Medicine that it will no longer publish studies unless they include detailed patient level study data. It further states they will print announcements for those that refuse to supply data. This is in response to the perception that pharmaceutical companies tend to publish clinical results in the best possible light.  At some level this is a bold step forward in getting a glimpse at the hordes of data pharma companies possess but the bigger issue is, does providing patient level data open up a study to misinterpretation of the data? Does it also potentially provide insight which could be useful to a competitor?

Barry Langdon
Barry Langdon  
2/27/2013 11:52:36 AM
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Transparency
Surely this has to be good news in particular for the ultimate consumers of pharmaceutical products - all of us.

Yes initially it will create costs but as in most of these situations it will also ultimately help to develop trust in an industry where the main news media inevitably dwells on the shortcomings and the mistakes.

Ultimately it may actually reduce costs where publication of negative results may reduce the amount of repetitive work, reinventing the wheel needed for every new drug development.

angelodp
angelodp  
2/27/2013 8:40:31 AM
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Re: Who pays?
In my opinion this should be a normal part of doing business. The largest expense is actually doing the trial; reporting those results should trigger only incremental costs. This measure, by the way, does not provide full transparency. That would involve publishing ALL trials.

Bikash Chatterjee
Bikash Chatterjee  
2/26/2013 3:46:16 AM
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Re: Yes, this needs thinking through
I think in principle this is the right direction to move towards  for patients but the mechanics of doing so in a pragmatic manner have not been established. The EMA recognizes this is and there are working groups that are attempting to establish pllatform solution that will work across regulatory bodies in the European Union. If you are intersted in this activty a great site to stay abreast of the progress is http://www.abpi.org.uk/media-centre/newsreleases/2013/Pages/010213-a.aspx

Rob Ratcliff
Rob Ratcliff  
2/25/2013 12:45:39 PM
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Who pays?
Who is going to pay for all this as well? Firstly, this will cost the Pharma companies thousands in preparing the relevant documents and then it'll cost the EU all of that again to process and read them, surely? Seems a potentially expensive folly. I see the benefits, but is it worth it?

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