Data Disclosure and Transparency - Applied Clinical Trials

ADVERTISEMENT

See our 2013 Buyers Guide Digital Edition.
Data Disclosure and Transparency

Source: Applied Clinical Trials

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in the many public problems (public perception of pharma, public safety) in regard to drugs that were subsequently withdrawn for safety reasons, and then found to have “hidden” data that supported the negative claims….and what we have is a new world of data disclosure and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.
He said, “How do we disclose, publish a richer patient centered representation of the study, not just at the last mile when we you get that the informed consent. How do we get that out there for their understanding and engagement?”

ADVERTISEMENT

blog comments powered by Disqus

ADVERTISEMENT

UPCOMING CONFERENCES

8th Annual Forum on Transparency and Aggregate Spend 2014
Washington, DC
August 18-20, 2014

eSource Data in Clinical Investigations
Philadelphia, PA
August 20-21, 2014

Pharmacovigilance 2014
Philadelphia, PA
September 10-11, 2014

Collaborative Research Summit
Philadelphia, PA
October 15-16, 2014

See All Conferences >>

Survey
As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
86%
Borrow lightly from EMA's pathway program?
6%
Create entirely its own pathway program?
7%
View Results
Untitled Document
Source: Applied Clinical Trials,
Click here