CLINICAL TRIAL DESIGN

By Deborah Borfitz

Dec. 1, 2008 | For 20 years now, Boston-based Eidetics has been conducting primary market research to help drug companies understand market dynamics and brand growth opportunities. Designing clinical trials attuned to real-world medical practice has been part of its mantra.

A division of Quintiles Consulting since May, Eidetics will now be using its flagship data analytics application to help parent Quintiles Transnational mine its “operations experience” – clinical trials involving more than 2.5 million patients – for lessons on improving the trial recruitment and enrollment process, says Vice President Jim Kirk. The software, known as Provenance, can also be applied to public-domain patient-level data collected and maintained by the U.S. Centers for Disease Control and Prevention to identify patient subgroups of interest or patterns of treatment or co-morbidities that should be factored into clinical trial design.

Jim Kirk

Provenance has been used commercially for close to three years now, answering questions such as how physicians make treatment decisions or which product features they find most appealing, says Kirk. “Now, we’re applying some of those same kinds of analytic tools to clinical data.”

Eidetics’ mission, as its name implies, is to provide a “vivid, detailed look at the marketplace,” says Kirk. It was a sensible acquisition target for Quintiles Consulting, given that both companies are committed to providing evidence-based advice. They also share some of the same clientele. Eidetics counts among its repeat customers 18 of the top 20 pharmaceutical companies.

Up to now, Eidetics’ involvement in the clinical trial enterprise has been limited to helping drug firms design Phase II and III trials that “speak to the marketplace” and address relevant endpoints, says Kirk. For example, it recently helped a client decide if a high-stakes central nervous system study would be more interesting to physicians as a comparator or placebo-controlled trial.

Designing trials to include – as much as possible – “real-world” patients with their attendant co-morbidities is a routine recommendation, says Kirk. The company also tends to encourage “non-esoteric metrics,” such as a short and simple quality-of-life instrument, to assess drugs’ clinical performance in a manner consistent with practical rather than theoretical medicine.

“Quintiles Transnational has really set its sights on helping bring good drugs to market faster and as safely as possible…and we play an important role in that,” says Kirk. “Part of what we do is to help clients design and execute clinical trials in a way that allows them to recruit more effectively and efficiently, target the right kind of patients, and measure the right endpoints.”

That Provenance provides a panoramic view of complex data and utilizes advanced data mining techniques and Bayesian networks may well position Quintiles to take a leadership position within the world of adaptive clinical trials, says Kirk. To date, Quintiles has conducted 400 trials using electronic data capture.

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