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New TrialScope platform aims to establish standard in global disclosure

Monday, August 14, 2017

Citing the need to meet requirements in 90 countries and across 30 trial registration websites, TrialScope has launched a “one entry” trial data disclosure platform. Its Core Disclosure solution is designed to allow research teams to approve disclosure once for worldwide dissemination.

“Core Disclosure moves toward the ever-elusive “standard” for disclosing clinical trial data,” Thomas Wicks, chief strategy officer at TrialScope told CenterWatch. “This model greatly reduces the risk of data entry errors and inconsistent data becoming available to the public.”

According to Wicks, Core Disclosure doesn’t just eliminate redundant work. It also offers the necessary legal and regulatory review and approvals to avoid making the data public anywhere in the world before it is ready for disclosure.

“Efficiencies are found not only with data entry, but also when reviewing and approving data before it is shared,” he said.

He defined disclosure as the “public side” of clinical trials information. If disclosure data are incorrect or inconsistent across various public access points, it can lead to questions about the reliability of the clinical trial sponsors and investigators.

In 2014, a study was published at PLOS ONE that re-measured a 2009 study to measure data disclosure compliance. It found that clinical trial registration quality was improving, but challenges were there. Among the study findings:

  • There was a significant increase from 38.2% to 57.6% in the number of primary outcomes that were specific measures with a meaningful timeframe.
  • There was a significant increase from 44.2% to 51.9% in the number of intervention arms that were complete in registering intervention specifics.
  • There was a small and not statistically significant increase from 81.0% to 85.5% in the percentage of records that provided a name of a contact person.
  • There was a significant increase from 68.7% to 74.9% in the number of records that provided either an email address or a telephone number.

The study authors concluded: “There have been small but significant improvements in the quality of registration since 2009. Important problems with quality remain and continue to constitute an impediment to the meaningful utilization of registered trial information.”

Wicks said that as time goes on and even more clinical trial data is available to the public, the pressure to make sure that data is consistent, accurate and timely will continue to increase. 
TrialScope worked with some of the largest clinical trial sponsors to arrive at what they see as a universal standard to achieve “data efficiency, accuracy and alignment.”

“We focus on an intuitive and easy interface to enter or import disclosure data and do the complicated work of conforming to the differing registry requirements behind the scenes,” he said.

Some of the key benefits to TrialScope’s Core Disclosure solution platform include:

  • Risk reduction by delivering a configurable list of fields along with simplified data entry
  • Streamlined process, offering a single master protocol form that lists key, common data elements across ClinicalTrials.gov and EudraCT
  • The ability to easily import and export ClinicalTrials.gov and EudraCT xml
  • A unified system to alert the user if data entry would cause an error in ClinicalTrials.gov or EudraCT
  • A “printer friendly” view of protocol disclosure content.

Wicks added that the information could be approved once, and then shared for local disclosure, either in a data format accepted by the trial registries or as a pdf document for any registry that does not support a direct data upload. This addresses the inherent issues of disclosing the same data on multiple registries—which drains significant time and resources and adds unneeded risk for sponsors. Core Disclosure addresses the need to streamline the disclosure process and eliminate wasted time and resources.

“The Core Disclosure form provides local personnel with a globally harmonized version of the key clinical information for disclosure, to which they can add any other data that might be required by local regulations,” said Wicks.

According to TrialScope, Core Disclosure can be purchased as a standalone solution. However, it is also designed to fully integrate with TrialScope’s other suite of offerings, including ATLAS and PharmaCM. The company also said it currently provides disclosure for more than 35 percent of industry-sponsored clinical trials posted on ClinicalTrials.gov.

 

This article was reprinted from Volume 21, Issue 32, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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