By Deb Borfitz
May 4, 2009 | The first enhancement to online study management technology PraxisDirect has all of the “motivation” features of its predecessor, including the delivery of pre-screened study candidates to sites and performance rankings based on how well those sites convert referrals to screened and randomized patients. But it surpasses the original version in terms of its forecasting prowess and convenience of use, says Donna Beasley, VP of operations at patient recruitment company Praxis. “We now have seven years of data, results, and relational modeling…to better predict and improve clinical trial enrollment,” says Beasley.
PraxisDirect, publicly launched in 2005, helps the company better manage centralized recruitment programs on behalf of sponsors. During the study planning stage, the tool helps Praxis formulate the optimal recruitment strategy for a particular protocol by cross-referencing various accumulated data points. At the implementation and study management stage, it provides study sponsors and sites with real-time, anytime information and analysis on recruitment activities, progress toward enrollment goals, and pre-qualified candidates. Notably, the latest version includes a customized dashboard with charts, graphs, and tables summarizing key information of interest to sponsors and sites upon login.
On multi-protocol projects, PraxisDirect gives sponsors the big picture on progress so it can intelligently shift resources from faster- to slower-enrolling protocols, says Beasley. With version 2.0, online pre-screening of subjects happens in multiple languages but amasses in a single language in one central database. Data from interactive voice response and clinical trial management systems can also be integrated with PraxisDirect so screening and enrollment views include study subjects that sites recruit on their own.
In the 2.0 version, it is simpler for sponsors “at a glance” to see how a site is performing because variables have been weighted and factored into one comprehensive score, says Beasley. The performance rankings show companies where they’re getting the best return on their recruitment buck, as well as inform sites how they’re doing relative to all other sites in a particular study. The rationale for how Praxis allocates resources is thereby “transparent.”
Beasley believes that sites are inspired to be proactive with recruitment by virtue of the rankings, availability of pre-screened candidates, and ready access to other information on the PraxisDirect webpage. This includes messaging with the patient recruitment coordinator at Praxis, a library of study-related references and easy-to-download recruitment materials, and links to all other web portals they regularly need to log onto for the study. Praxis also posts a weekly trivia question about the protocol and praises the first correct answer with a modest prize and an announcement on PraxisDirect.
PraxisDirect 2.0 was first utilized on a phase II study, resulting in a 22% increase in sites’ patient screening rate over a prior similar study where the original version of PraxisDirect was utilized, says Beasley. The study also finished enrollment ten months earlier. “We noticed the study coordinators were more responsive to pre-qualified candidates. [PraxisDirect] was easier to use and information on the dashboard was more useful, so site staff logged on more often, staying more involved in this sponsor’s study.” Part of the gain was achieved by building upon the “brand awareness” established with the first study.
At any one time, Beasley says the software is being utilized by Praxis on behalf of 15-20 industry sponsors. Because its purpose is to make trials more cost efficient, PraxisDirect has been unaffected by the economic recession. “This year, we’re off to a busy start,” she says.