Janssen Tests Ideas, Apps, in Bid for Clinical Trials Innovation

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As the cost and complexity of drug development has skyrocketed in recent decades, Big Pharma has focused increasingly on improving the way clinical trials are conducted.

In 2007, the FDA and Duke University Medical Center established a public-private collaboration called the Clinical Trials Transformation Initiative (CTTI). The idea was to streamline the process so clinical trials could be done more quickly and efficiently while maintaining patient safety and ensuring data reliability and integrity. In 2012, ten pharmaceutical giants followed suit by forming a nonprofit, Transcelerate BioPharma, with the goal of accelerating drug development while eliminating the inefficiencies that drive up R&D costs.

Johnson & Johnson, a central player at the beginning of both CTTI and Transcelerate, also established a team focused on clinical trial innovation that through its Janssen Healthcare Innovation and Janssen Research and Development units. The San Diego-based group is led by Andreas Koester, a Janssen executive who says his latest efforts are focused in particular on making the process easier for two key groups of constituents—patients and principal investigators.

The underlying premise, Koester says, is “to share information readily with others, so everyone doesn’t have to reinvent the wheel” for each clinical trial. In other words, to apply advances in information technology that have transformed other industries over the past two decades to reduce costs, improve data collection, and quality, and to expedite the time required to stage clinical trials.

To help principal investigators, Koester worked with Merck and Eli Lilly to help create a shared resource known simply as the “Investigator Databank.” As Koester told me in 2012, the databank is intended to alleviate the red tape that Big Pharmas impose on principal investigators. Instead of requiring the academic scientists who oversee clinical trials to file the same regulatory documents and certifications again and again for each clinical trial, they can now upload such documents to the databank, which is hosted by DrugDev and is now shared by Janssen, Lilly, Merck, Pfizer (other pharmaceuticals are expected to join in the collaboration).

Since it was created, the Investigator Databank has grown to contain data from over 120,000 principal investigators and more than 25,000 clinical trial sites, with full details on more than 4,000 clinical studies. More recently, the website InvestigatorDatabank.org has been added to … Next Page »

Bruce V. Bigelow is the editor of Xconomy San Diego. You can e-mail him at bbigelow@xconomy.com or call (619) 669-8788 Follow @bvbigelow

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