Janssen Research & Development, based in Raritan, N.J., has established a global cross-pharmaceutical Investigator Databank designed to improve efficiencies of industry-sponsored clinical trials. Merck and Eli Lilly are the first two companies to join Janssen in this effort.
The new Investigator Databank, established as part of this novel industry collaboration, will serve as a one-stop repository where key information about clinical trial sites, such as infrastructure and Good Clinical Practice (GCP) training records, is housed. This will allow participating pharmaceutical companies to reduce time-consuming and sometimes redundant administrative work involved in identifying appropriate clinical trial sites.
At the outset of every clinical trial, pharmaceutical companies initiate clinical trial site selection, prequalification and GCP training, which can be paperwork-heavy and time-consuming for trial sponsors and investigators alike. By housing critical information about investigators and trial sites in one place, the databank will reduce time, cost and duplicative efforts, making it easier for 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.
"The current clinical trial environment is inefficient, costly and unsustainable. The Investigator Databank can help expedite the process to achieve our most important goal - to deliver high-quality, effective novel medicines to the patients who are waiting for them," said Andreas Koester, head of clinical trial innovation/external alliances, Janssen R&D. "We are enthusiastic about working with other industry leaders to collectively apply our expertise, capabilities and shared passion for advancing science and improving lives."
Earlier this year, Janssen joined nine other companies to launch TransCelerate BioPharma, the largest initiative of its kind, which aims to identify and overcome common drug development challenges in order to improve the quality of clinical studies and to bring new medicines to patients faster. 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.
"Industry collaboration, including pre-competitive data sharing, is critical to ensuring continued progress to improve industry-wide clinical trial practices," said newly appointed CEO of TransCelerate BioPharma, Garry Neil, partner at Apple Tree Partners and former corporate vice president, science and technology, Johnson & Johnson. "This work is aligned with TransCelerate's initial focus on clinical study execution and we encourage participation from our founding TransCelerate companies to solve industry-wide challenges in a collaborative environment."
Member companies of TransCelerate who 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.