IT answers sticky trial-startup challenges

Subject recruitment difficulties are driving solution developments based on Web 2.0 capabilities and data mining, according to John Johnson, associate director for statistics at Cato Research, in Ask Cato. Johnson reports on presentations made at the Leo Intelligence Group's "Future of Clinical Trials" conference last month in San Francisco. Johnson himself spoke on adaptive trials, his area of expertise.

He also summarizes other conference presentations, two of which describe IT-based solutions to trial-startup challenges. One is a Web 2.0 solution for capturing site data across projects and to help sponsors match investigative sites and potential partners to their project needs. Such a system is available from study-startup portal, which currently boasts data on 17,000 investigative sites worldwide, according to the company.

The second development targets subject recruitment and involves tapping insurance claims data to identify subject populations, according to Johnson. Subject-recruitment specialist Acurian, for example, has allied with insurance claims processors to offer access to details on more than 60,000 investigators and millions of patients, the company says.

Regarding adaptive trials Johnson says that even "tiny improvements" in the process can prove great contributors to success, especially in cases that involve a process step that is executed many times or one that comes at a time-critical part of the trial. That's particularly true in adaptive trials, he writes, in which interim analyses may be executed several times.

- here's his report