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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
The launch of a global cross-pharmaceutical Investigator Databank follows the formation of TransCelerate BioPharma, another industry collaboration to address challenges in drug development.
Janssen Research & Development, part of Johnson & Johnson, announced the formation of a global cross-pharmaceutical Investigator Databank to improve efficiencies of industry-sponsored clinical trials. Merck & Co. and Eli Lilly are the first two companies to join Janssen in this effort. The creation of the Investigator Databank follows the launch of TransCelerate BioPharma earlier this year, another industry collaboration formed to address challenges in drug development.
The new Investigator Databank is designed to be a one-stop repository where key information about clinical-trial sites, such as infrastructure and good clinical practice (GCP) training records, are housed. The aim is to reduce time-consuming and sometimes redundant administrative work involved in identifying appropriate clinical-trial sites. At the outset of clinical trials, pharmaceutical companies initiate clinical-trial site selection, prequalification, and GCP training, which can be paperwork-heavy and time-consuming for trial sponsors and investigators. By housing crucial information about investigators and trial sites in one place, the databank is designed to reduce time, cost, and duplicative efforts to make it easier for participating companies to identify appropriate trial sites and investigators for future clinical trials. Investigator sites that have opted-in to data-sharing will have their relevant information accessible to pharmaceutical companies participating in the collaboration. This databank will not include any patient data.
Earlier this year, Janssen joined nine other companies to launch TransCelerate BioPharma. The initiative identified the centralization of site prequalification and training as one of five key projects, and the Janssen-led Investigator Databank project will serve as a foundation for the TransCelerate initiative. Member companies of TransCelerate that wish to join the Investigator Databank will automatically qualify for participation. It is anticipated that the Investigator Databank will be operational by the end of the year and incorporated into one of the priority projects within TransCelerate by mid-2013.The Investigator Databank will be hosted by DrugDev.org, an independent, third party with expertise in clinical-trial information technology and investigator community management.