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The first conference I’ll attend this year is in two weeks in Philadelphia, on Data Disclosure and Transparency. I’m excited about it for many reasons: the content looks excellent; there are a good number of registered attendees; many of the speakers have agreed to be interviewed on camera, so we can post insights on our website, and many also agreed to share selected portions of their slide presentations with the Applied Clinical Trials audience. In the essence of disclosure and transparency, these participants are obviously on board with their topic.
This CBI conference used to be called Clinical Trial Registries and highlighted the difficulties sponsors have in getting clinical trials information into a multitude of countries’ databases as required by the regulatory authority, which obviously is still a critical piece of data disclosure.
In 2004, the International Committee of Medical Journal Editors (ICMJE) required its member journals to only consider for publication those articles that refer to clinical trials, that those trials be registered in a public trials registry. This was its attempt to strengthen the body of evidence for clinical decision-making by addressing the issue of selective reporting of trial data. Another piece to the transparency and disclosure picture.
Related to that, is the registry of clinicaltrials.gov, which started in 1997, but didn’t require trial data results reporting until 2007. Clinicaltrials.gov is sometimes criticized of not being patient or consumer-friendly, as much of the wording and descriptions are more industry and scientifically-related. CISCRP has conducted much research into how participants and the public view clinical research. They have also shown that study volunteers want to know the outcomes of the clinical trials in which they participated.
Then factor in the many public problems (public perception of pharma, public safety) in regard to drugs that were subsequently withdrawn for safety reasons, and then found to have “hidden” data that supported the negative claims….and what we have is a new world of data disclosure and transparency.
There are many nuances and stakeholders to this new world of disclosure and transparency Thomas Krohn, Director, Clinical Open Innovation at Eli Lilly took disclosure to another level, when I spoke to him in regard to another upcoming CBI conference on Clinical Technologies, where he is giving the innovation address to the audience in March.
Krohn is very clearly supportive of the idea of data and technology as a key to innovation, and putting patients at the center of many of our industry’s processes.