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J&J, Lilly and Merck join forces on clinical trials

Will set up database to improve efficiency of industry-sponsored drug trials

J&J, Lilly, Merck

Three of the world's largest pharma companies have set up a clinical database which aims to improve the efficiency of industry-sponsored drug trials.

The collaboration between Johnson & Johnson, Merck & Co and Eli Lilly ties in with the growing trend towards collaboration rather than competition between the big players in pharmaceutical R&D.

The three companies will all contribute information into an Investigator Databank, which will serve as a repository of information on clinical trials sites' capabilities, including Good Clinical Practice (GCP) training records.

The aim is to get trials up and running more quickly and ultimately bring new medicines to market earlier and at less cost than the currently quoted figure of more than $1bn apiece. The three founding partners are encouraging other pharma companies to get involved in the project.

"The current clinical trial environment is inefficient, costly and unsustainable," said Andreas Kostner, head of clinical trial innovation and external alliances at J&J's Janssen R&D unit and one of the architects of the new database.

The cost of clinical trials is said to be rising rapidly as drugmakers scramble to replenish product pipelines, and there is greater competition for trial sites, as well as increasing costs associated with patient enrolment, according to a 2011 Cutting Edge Information survey. The study found per-patient costs for a phase III trial rose from $25,000 to $57,000-plus between 2008 and 2011.

The new databank is expected to help alleviate some of these difficulties when it gets  up and running later this year, and will initially have details of around 100,000 investigators, said J&J.

The resource will reduce time, cost and duplicative efforts, making it easier for companies to identify appropriate trial sites and investigators for future clinical trials, added the company.

Janssen has taken a collaborative approach to other areas of the pharma R&D process, joining forces with nine other companies in September to create the TransCelerate BioPharma initiative, designed to tackle bottlenecks in the drug development process.

The new databank is one pillar of the TransCelerate project, with others including mutual recognition of study site qualification and training and the development of a risk-based site-monitoring approach. It will also work on clinical data standards and a comparator drug supply model.

"Industry collaboration, including pre-competitive data sharing, is critical to ensuring continued progress to improve industry-wide clinical trial practices," said TransCelerate chief executive Garry Neil.

16th November 2012

From: Research



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