Adaptive trials lead to enhanced patient safety, more efficient Phase I/II studies.

WASHINGTON--Adaptive clinical trials lead to greater patient safety, faster decisions and more effective Phase I and Phase II studies, an electronic data capture (EDC) expert stated here July 10.

Sam Hume, VP of technical operations at Phoenix Data Systems, told the July 10-11 Exl Pharma conference that such trials lead to balanced randomization. Also, in Phase I and Phase II, critical dose selection and advancement are aided.

Technologies that are key to the development of adaptive trials, he said, include:

* EDC

* IVRS (interactive voice response services)

* Real-time analytics

* Real-time reporting

* Clinical trial supplies management

* Integrating the determining analytes

* ePro

"These systems allow the collection of clean data, real-time data access, process visibility and control, dynamic adaptations and timely deployment," Hume stated.

Technology used to collect clean data allows the intelligent use of edit checks; complex, real-time edit checks; batch edits; and, dynamic, rule-based, study-design changes. Workflow tools and exception reporting and visualization also are available.

Available real-time data access technology includes:

* Web reports

* Ad hoc reporting

* Data exports

* SAS exports

* PDF IPPs

* EDC workflow

* Safety data

* Lab data

* IVRS/EDC integration

* Drug supply data

* CTMS integration

In real-time analytics, "capturing clean data is required," Hume said. "Real-time data access also is needed, as well as process visibility and control. He cautioned, however, that real-time analytics does not happen in real time.

Most analyses must be done on clean data, and data collection and review processes are not enough. "Interim lock processes likely will be applied," he said.

These can be difficult to get right and require planning, and often they are not fully automated. That is why the rules for interim locks need to be defined in advance, and timelines also should be agreed to in advance.

In dynamic adaptations, Hume stressed that EDC/IVR products differ widely on their flexibility to support dynamic study design changes. More significant due diligence is required.

When considering technology for dynamic adaptations, he said that it is important to ask how much EDC data is available to the IRVS.

"Is it tightly integrated?" he asked. Adaptive EDC systems also can be used, and it is possible to build appropriate adaptive procedures in to the EDC system.

Hume added that all of this technology will fail without appropriate processes--"a plan for interim locks, analysis and deployment."

By Joseph Pickett Managing Editor