Inside AstraZeneca's DISCLOSE process

Besides meeting its transition studies CTIS deadline, the company has made major strides in streamlining processes and tech integration to improve its global clinical trial disclosure requirements.

Radoslaw Grabowski Head of Registries, Clinical Trial Transparency at AstraZeneca opened his presentation at Clinical Data Disclosure Europe, asked the audience if anyone had a fully comprehensive, fully automated Clinical Trials Information System (CTIS) process. No one did, which pretty much underscores the need for this audience to learn from others. And that is what Grabowski provided as he delved into the workings of AstraZeneca’s DISCLOSE system and its role in meeting regulatory requirements, particularly for CTIS in the European Union.

One of the key challenges in clinical trial disclosure is the initial application process. AstraZeneca has made significant strides in automating this procedure by leveraging its existing cloud platform. "AstraZeneca is using already existing cloud platform that is integrating some of the information," the representative states. "We have Planit that holds our projection milestones, we have the CTMS [Clinical Trial Management System]... and then we have DISCLOSE," said Grabowski.

DISCLOSE serves as the company's master system for holding submission information related to clinical trials. The integration Grabowki described allows for seamless data transfer between systems, reducing manual entry and potential errors. However, the process is not yet fully automated. The company still relies on an "offline form" to supplement the data collection, particularly for information that cannot be automatically pulled from other systems.

Radoslaw Grabowski, Head of Registries, Clinical Trial Transparency at AstraZeneca

Results data automation

When it comes to reporting clinical trial results, AstraZeneca has implemented a semi-automated approach. The company uses XML files to upload certain types of results data to the DISCLOSE system.

"Some of results can be uploaded via the XML file to DISCLOSE," Grabowski explained. "The creation process is followed by the statistical programmer who is creating those XML files based on the SAS data sets." After that, it goes through the IT integration platform, carried over to close, where a macro program compile the data and reformat them from the SAS into the XML.

"AstraZeneca recommendation is that we use those standard macro programs across all our studies so that the outputs are similar in the process," Grabowski added, highlighting the company's efforts to standardize and streamline its reporting procedures.

Workarounds and successes

Despite the integrated systems in place, AstraZeneca, like many in the industry, faces challenges in fully automating the disclosure process. Grabowski candidly admits, "We still haven't found a really good way how to write a macro to carry across outcome measures. If anyone has that, I'm really happy to have a coffee with you and discuss how you did it, because we're still not there yet."

Also critical is managing confidential commercial information (CCI) and personal protected data. AstraZeneca has implemented a centralized redaction process to handle this sensitive task.

"We have a central redaction team that is redacting the documents from the confidentiality company, confidential information and the patient, protected data," Grabowksi said. This team works closely with document requesters and CCI identification groups to ensure all documents are appropriately redacted before submission.

The process involves multiple checks and balances: "When there's no more comments, when everything is redacted, we have a fully redacted document with our patient protected data and company configuration information masked." The company only redacts the master copy in English, relying on local study teams to handle documents in other languages based on the master redaction.

In addition to technical disclosures, AstraZeneca has integrated the creation and publication of plain language summaries into its DISCLOSE process. These summaries, also known as lay language summaries, are designed to make clinical trial information accessible to a broader audience.

"The language summaries are business as usual for us," Grabowski noted, indicating that this practice predates current regulatory requirements. AstraZeneca publishes these summaries not only on the required CTIS platform but also on the TrialSummaries.com Another success Grabowski called out was the submission of all AstraZeneca’s transition studies as of October. Transition studies are those trials that are running in the EU after January 31, 2025 and need to go to CTIS from EudraCT. “There was a really big push and really cross functional work to make it happen, and we did,” said Grabowski.

AstraZeneca will continue working with Citeline to develop a single form collecting CTIS, as well aiming to reduce duplicated efforts and streamline processes further. It has UAT testing already underway and pilot studies planned for early 2025.

Learn more about disclosure, lay summaries at our upcoming conference.

Quotes lightly edited for clarity.