the beginning of an end…

Posted on Friday 15 August 2014

Finally wading through my emails for the 10 days I was gone, I ran across this:

August 8, 2014

Thank you for your email of 20 May 2014 and the EMA request for information (reference number 3644) of 10 June 2014 concerning the draft policy on proactive publication of and access to clinical trial data. Your email and your request for information have been received and your comm

Yours sincerely

Guido Rasi
Executive Director
European Medicines Agency

Having had some experience with the screen-only interface proposed for the EMA Data Transparency, we were among the throng that complained about their proposed use of such a system. We had written:

… In writing about your proposal [the U-Turn…], I made the analogy, "It’s like going to sea to see the world in a submarine looking through a periscope." If anything, that’s an understatement. Trying to review the CRFs in the single window interface is beyond difficult. In our case, there are 275 subjects with the CRFs averaging over 200 pages each [more than 55,000 pages]. The data tables are equally voluminous making computation and extraction of data very difficult. I don’t know what process suggested that you change your policy, but it makes data analysis extremely awkward. I would suggest you have one of your own scientists try it out to see how really obstructionistic this policy is going to be. Please consider going back to the plan of access originally described…

As you may recall, the promise of the EMA [European Medicines Agency] to release all of the data for clinical trials hit a snag with add-on restrictions [see also Welcome to Troy, Ombudsman concerned about change of policy at Medicines Agency as regards clinical trial data transparency, EMA policy on publication of and access to clinical-trial data, the U-Turn…]. There was much wailing and gnashing of teeth [the end game…, to be continued…, a decision to reconsider…, a crushing setback…, oh how we’ve missed our Pharmalot!…]. And then they recanted! [awaiting further information…, some further information…, out of the shadows…]. And then, as they say above, they put off their decision until October 2, 2014.

Is there something that brings this to mind other than getting a belated response from Dr. Rasi? It’s my ongoing suspicion that the tenacles of PHARMA are never still. We may be waiting expectantly, but you can count on the fact that the PhRMA/EFPIA lawyers are burning the candle at both ends in this lull:
In the illusion of evidence… and beyond…, I was echoing Dr. Healy’s point that Clinical Trial Data Transparency is just a starting place, not a destination. The escalation of Clinical Trials, Algorithms, and Treatment Guidelines to the level of Dogma is also a big problem – perpetuating somebody’s silly fantasy that a group mean in a controlled trial can direct treatment for individual patients. That said, insisting that the data from Clinical Trials is freely available for independent analysis is of vital importance to insure accurate baseline efficacy and adverse event data as a drug enters the real arena of clinical medicine. This coming EMA policy is going to be the linchpin for establishing integrity in Clinical Trials if properly implemented – the beginning of an end to the untenable notion that patient data is the proprietary property of trial sponsors…
    August 17, 2014 | 8:46 PM

    What next? Invisible ink?

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