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Clinical Site Performance

By Ann Neuer

August 8, 2007 |  Finding sites that can recruit the contracted number of study volunteers and generate clean clinical trial data remains one of the key challenges in clinical development. Only 20-30 percent of sites actually perform as promised.

But a San Mateo, Calif.-based start-up, TrueTrials, is set to launch in August a Web-based system that relies on transparency to improve the manner in which sponsors and contract research organizations (CROs) select investigative sites.

TrueTrials’ vision is to enable high-performing sites to build solid reputations, eBay style, by documenting their performance. This is done by inviting them to enter their performance data online as a clinical trial unfolds. Over time, a database will be established that will identify sites that are performing in various therapeutic areas. The better performing sites — as well as the weaker ones — will become visible as their composite information is made available for the clinical trials community.

TrueTrials expects that sites will be motivated to perform up to par to maintain a good rating, or else opt to walk away from a potential study in which they are unlikely to succeed. “Sites will need to be brutally honest with their self-assessment for performing successfully on a trial. There will be nowhere for poorly performing sites to hide,” says Sooji Lee-Rugh, CEO and co-founder of TrueTrials. 

TrueTrials expects the next major release of its technology platform to occur in the next few months. David Chan, CTO, says the new release will use Asynchronous JavaScript and XML (AJAX) technology to improve user experience and simplify sponsor/CRO- site matches. 

The company will start populating its database with lists of investigative sites that are currently in the public domain. Sites will also be invited to register with TrueTrials by completing an application that will enable sponsors and CROs to locate desired traits when they perform searches. The completeness of their entry will determine how sites will rank in the search. “Even this first step is intended to create motivation for sites to complete as much information as possible because it will increase the visibility of their site,” Lee-Rugh remarks. 

“The focus of our site selection technology is to provide a tool for sponsors and CROs to perform the best search and make the best matches possible,” says Lee-Rugh.

“Instead of sponsors driving the site selection process based on fragmented information, sites will be able to level the playing field by providing data that will be of interest to sponsors who may not know about them. This will benefit all stakeholders who want to see changes in how sites are selected.”

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