Closer to Transparency

To be sure, the road to clinical trials transparency is paved with good intentions—from the architects of www.clinicaltrials.gov/, to the sponsors, to the "external" stakeholders. But this road is proving to be a difficult one to travel.

Internal Stakeholders

Nicholas Ide, chief architect of www.clinicaltrials.gov/ and contractor to the National Library of Medicine, offered some insights into these difficulties at a Center for Business Intelligence (CBI) conference last month in London. The Clinical Trials Registries and Results Databases conference—the first held outside the United States—covered global and U.S. requirements.

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 www.clinicaltrials.gov/ site.

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 www.clinicaltrials.gov/ PRS database, and none have been approved.

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 www.clinicaltrials.gov/ and the United States for guidance in this area. The U.S. leads in the results posting, and most sponsors must conform to market their drugs here.

The Spring meeting of the www.clinicaltrials.gov/ is scheduled for April 20. Coincidentally, CBI's 4th Forum on Clinical Trials Registries and Results Databases will be held in Arlington, VA, April 21–22. Nicholas Ide is set to offer an update from this Spring Meeting at the CBI event.—Lisa Henderson