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Clinical Research
Off-shoring: A Country Attractiveness Index for Clinical Trials

By Mark P. Mathieu
For many years, pharmaceutical companies have been off-shoring manufacturing operations to lower-cost countries. Healthy margins and strong risk aversion have afforded pharmaceutical companies the luxury of staying close to home, for all but manufacturing activities. As financial pressures increase, pharmaceutical executives are finding that going offshore is not only less risky than it once was, but also too attractive to ignore.  Read More



Healogica to Exit Difficult Market for Online Trial Matchmakers



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By Deb Borfitz

February 3, 2010 | It’s an ostensibly sound idea: give the Internet-savvy masses a simple, high-speed search tool for navigating a comprehensive but cumbersome clinical trials listing website. But industry sponsors have deep reservations about the concept, effectively taking down at least two otherwise promising trial matchmaking services.

In 2008, after nearly a profitless decade in the business, Veritas Medicine dropped its user-friendly trial listing service that matched potential participants with clinical trial operators based on self-created online profiles. Fledgling online matchmaker Healogica, operating for the past two years out of an apartment in New York City’s Upper West Side by entrepreneurs Edward Shin and Jean-Luc Neptune, is now planning its exit strategy.

Neptune and Shin, both MDs trained in internal medicine, co-founded Healogica believing clinical research sites would happily pay for access to screened patient candidates actively pursuing trial opportunities. It became apparent early on that sites were interested but lacked the capital to pay for the leads generated, says Shin, so the company instead sought the support of trial sponsors and clinical research organizations (CROs).

The massive ClinicalTrials.gov trials listing site contains much of the information consumers might want to know about many research studies, presuming they have an abnormally long attention span, says Shin. A random search for a diabetes trial might turn up hundreds of possibilities, but the would-be participant would probably, at best, qualify for only a handful of them. Healogica-Clinical Trials 2.0 distills complicated free text within ClinicalTrails.gov trial listings into categories that can be used to match candidates.

Uptake of Healogica-Clinical Trials 2.0, commercially introduced in early 2008 with a staff of three, was relatively encouraging, says Shin. “At its peak, without spending a dime on marketing, we were getting 15,000 to 16,000 unique visitors per month.” To date, about 2,000 people have registered at the company’s website and filled out a brief questionnaire to help narrow their search to clinically appropriate and geographically convenient clinical trials. “Even our competitors [Inspire.com and TrialX] have said we have an elegant solution.”

The Healogica database is currently comprised of 30,000-plus clinical trials covering dozens of conditions. A widget allowing users to search for trials by disease and postal code from any website was just introduced in September. An iPhone application was most recently launched to expedite matches and a backend tool, allowing investigators to find patients, was about to be released.

Despite their perennial recruitment blues, industry sponsors and CROs have yet to embrace the Healogica platform and its founders simply haven’t the wherewithal to weather a protracted sales cycle. Shin now thinks it could be another decade before the subject-trial pairing idea is ready for “prime time.” Even market leader Acurian, which raised $30 million to jumpstart its direct-to-patient recruitment approach, has only recently reached the break-even point, he notes.

The central struggle for online matchmakers is the “regulatory/legal paralysis of the industry,” says Shin. “Pharmaceutical companies are so conservative about regulatory hurdles and liabilities and perceived liabilities when it comes to interacting directly with consumers.”

It’s an extension of broader industry fears about “downside risks” presented by social networking sites and other online forums where information control is impossible, adds Neptune. For competitive reasons, pharmaceutical firms prefer to be quiet about what drugs they’re testing and where those studies are being placed. Focusing on site identification rather than recruitment techniques to find patients helps preserve the veil of secrecy.

The situation is likely to change for the better, though not soon enough for Healogica. Last November, the Food and Drug Administration kicked off a year-long fact-finding mission that will result in industry guidance about online interactions with consumers. The last time such guidance was issued was in 1996, during the early days of the web, says Neptune.

The Healogica website will remain functional for at least the next few months, says Shin. In the meantime, the tool has been offered to ClinialTrials.gov free of charge to simplify consumer searches. Director Deborah Zarin, MD, has yet to respond.

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