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Johnson & Johnson, Merck and Eli Lilly to rip red tape from clinical trials

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Johnson & Johnson's ($JNJ) Janssen R&D unit is leading a charge to expedite the tedious process of selecting sites for clinical trial sites, with the creation of a investigator database intended to get studies up and running more efficiently. Merck ($MRK) and Eli Lilly ($LLY) have teamed up with Janssen for the unprecedented database, called the Investigator Databank, which the pharma giants aim to have up and running by the end of the year.

The investigator database will buttress the efforts of a nonprofit announced in September called TransCelerate BioPharma, which included J&J and 9 other Big Pharma outfits as founding members to support 5 programs to streamline the clinical development process. The database is expected to offer "one-stop" access to information about clinical trial sites, including the fine details on available equipment to support studies and important training records. Lacking such a resource, pharma companies and investigators have been inundated with administrative burdens, redundant efforts and other hassles to complete the site-selection process.

TransCelerate plans to have the databank incorporated into one of its 5 priority projects by mid-2013, according to Janssen's release. Founded in August, TransCelerate's charter members included J&J, Abbott ($ABT), AstraZeneca ($AZN), Boehringer Ingelheim, Bristol-Myers Squibb ($BMY), Eli Lilly ($LLY), GlaxoSmithKline ($GSK), Pfizer ($PFE), Roche's ($RHHBY) Genentech unit and Sanofi ($SNY). These companies are seeking pre-competitive ways to make drug development--which costs them billions of dollars for new products--more efficient.

"The current clinical trial environment is inefficient, costly and unsustainable," Dr. Andreas Koester, Janssen's head of trial innovation and external alliance, said in a statement.

As Koester told Reuters, the partners have started to collect approvals from 100,000 or so clinical investigators to put their information in the database. "The feedback we have gotten so far is ... they can't wait to get rid of the administrative burden and red tape," he told the news service. And other companies could join the effort after the database goes live.

- here's the release
- check out Reuters' article

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