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Making trials less of a trial
RARITAN, N.J.—Mid-November saw an ambitious attempt to rein in some of the costs and challenges of clinical trials as Janssen Research & Development LLC (Janssen R&D) announced the Investigator Databank, a global cross-pharmaceutical effort designed to improve efficiencies in industry-sponsored clinical trials.
As the Investigator Databank makes it entry onto the scene, Merck & Co. Inc. and Eli Lilly & Co. are the first two companies working with Janssen in this effort, though it is hoped that more will join in as well as time goes on.
The idea behind the Investigator Databank and this novel trial-focused industry collaboration is that companies can ultimately have, as the partners put it, "a one-stop repository where key information about clinical trial sites, such as infrastructure and good clinical practice (GCP) training records, is housed." Ideally, this would allow participating pharmaceutical companies to reduce time-consuming and sometimes redundant administrative work involved in identifying appropriate clinical trial sites.
"The current clinical trial environment is inefficient, costly and unsustainable," according to Dr. Andreas Koester, head of Clinical Trial Innovation/External Alliances at Janssen R&D. "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. We are enthusiastic about working with other industry leaders to collectively apply our expertise, capabilities and shared passion for advancing science and improving lives."
At the start of every clinical trial, pharmaceutical companies have to go through clinical trial site selection, prequalification and GCP training, which can be paperwork- heavy and time-consuming for trial sponsors and investigators alike, Janssen R&D notes. Theoretically, if critical information about investigators and trial sites is stored and organized in one place, the databank will reduce time and costs for pharma and biotech companies, making it easier for them to identify appropriate trial sites and investigators for future clinical trials.
As important as the bottom-line benefits may be to companies, the importance of reducing duplicative efforts for the sake of site investigators themselves should not be minimized, notes Koester, estimating that two-thirds or more of investigators only do one or a few trials "and then call it quits." He has suggested that part of the reason for this is burdensome document requirements, with investigators often needing to deal with many companies, each of which likely has completely different paperwork requirements.
The Investigator Databank will not include patient data, Janssen R&D reports, and investigator sites that opt in to data sharing under the program will have their relevant information accessible to pharmaceutical companies participating in the collaboration.
As ambitious as this project is, it's really only part of a much larger effort. Earlier in 2012, Janssen (or, more precisely, its parent company, Johnson & Johnson) joined with nine other top pharmas and put competition aside a bit to help form a nonprofit consortium—TransCelerate BioPharma Inc.—dedicated to accelerating the development of new medicines. Lilly is another member of the consortium, though Merck, as of the writing of this article, was not yet a member of TransCelerate despite being part of the Investigator Databank. The other eight founders of TransCelerate are Abbott, AstraZeneca PLC, Boehringer Ingelheim, Bristol-Myers Squibb Co., GlaxoSmithKline PLC, Genentech (a member of the Roche Group), Pfizer Inc. and Sanofi.
When the companies met to launch TransCelerate, their overarching goal in this largest initiative of its kind was to identify and overcome common drug development challenges with an eye toward improving the quality of clinical studies and bringing new medicines to patients faster. The TransCelerate founders 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 that part of the TransCelerate initiative.
"Industry collaboration, including pre-competitive data sharing, is critical to ensuring continued progress to improve industry-wide clinical trial practices," said the CEO of TransCelerate BioPharma, Dr. Garry Neil, a partner at Apple Tree Partners and formerly corporate vice president of science and technology at Johnson & Johnson, in the news release about the Investigator Databank. "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."
Clinical trials are the "lowest- hanging fruit with the biggest short-term payoff," Neil told ddn in October when interviewed about TransCelerate. "This really is about accelerating innovation in drug development and getting more drugs to patients. What we are trying to do is shorten that timeline and make sure products are properly tested."
Member companies of TransCelerate who wish to join the Investigator Databank will automatically qualify for participation. The trio of companies founding the databank anticipates that it 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 entity with expertise in clinical trial information technology and investigator community management.