
- Applied Clinical Trials-03-01-2009
- Volume 0
- Issue 0
Closer to Transparency
London conference underscores foggy climate surrounding clinicaltrials.gov
To be sure, the road to clinical trials transparency is paved with good intentions—from the architects of
Internal Stakeholders
Nicholas Ide, chief architect of
To date
Basic results reporting requirements went into effect September 27, 2008. As of last month, 250-plus results were submitted. Of those, approximately 46 had been "published" or made available on the site. So where are the balance of the results? Back to the sponsors for data clarification and cleanup.
"The data we have been getting is difficult to understand and the quality is pretty bad," Ide told the audience via teleconference. He provided actual examples of data errors, which are housed on the
However, one attendee responsible for transparency compliance at a large global pharma told Applied Clinical Trials that the company had submitted 40 results to the
Ide seemed optimistic that most of these issues were just a part of the learning curve. He recommended that sponsors input one study at a time. "Go through one, and learn lessons from that," he said. Also, people intimately involved with the study, along with a statistician, were recommended by Ide for the results input responsibility.
Ide also said that his group has its own learning curve. "We are considering adding rules into the database so information is flagged up front (for example on data inconsistencies) on the input and then it can be more streamlined."
Sponsor challenges
To wit, many of the attendees who were appointed or adopted to take on these requirements spanned regulatory to legal (see sidebar). Further, the functions related to the registries and results include protocol writing, study report preparation, Form FDA 3674 certification, just to name a few.
The challenges with these many functions and stakeholders according to Paarlberg are keeping SOPs up to date and the training that goes along with that. Many attendees questioned the ability—or rather inability—of data to be kept standardized with the different systems.
Many countries—such as Israel, Italy, and Taiwan—have a registries mandate in place, said presenter John McKenney, SEC Associates. The Czech Republic posts the trials itself, and other countries are discussing the implementation and responsibility aspects of trial registration. Following all of the countries' requirements is also a challenge for sponsors.
However, all eyes are on
The Spring meeting of the
Articles in this issue
over 16 years ago
Putting a Face on EDCover 16 years ago
Patient Powerover 16 years ago
Transparency Shapes Pharmaceutical R&Dover 16 years ago
Poll Finds Ironic Inefficiencyover 16 years ago
Is Clinical Research Recession Proof?over 16 years ago
Managing Content in 2009over 16 years ago
Eliminate the Disconnect in a Systems Approachover 16 years ago
What I Learned as a Subjectover 16 years ago
Risk Response: Constructing a Planover 16 years ago
EU-Born HIV Study: History in the MakingNewsletter
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