Making trials less of a trial

RARITAN, N.J.—Mid-November saw an ambitious attempt to reinin some of the costs and challenges of clinical trials as Janssen Research& Development LLC (Janssen R&D) announced the Investigator Databank, aglobal cross-pharmaceutical effort designed to improve efficiencies inindustry-sponsored clinical trials.

As the Investigator Databank makes it entry onto the scene,Merck & Co. Inc. and Eli Lilly & Co. are the first two companiesworking with Janssen in this effort, though it is hoped that more will join inas well as time goes on.

The idea behind the Investigator Databank and this noveltrial-focused industry collaboration is that companies can ultimately have, asthe partners put it, "a one-stop repository where key information aboutclinical trial sites, such as infrastructure and good clinical practice (GCP)training records, is housed." Ideally, this would allow participatingpharmaceutical companies to reduce time-consuming and sometimes redundantadministrative 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 ClinicalTrial Innovation/External Alliances at Janssen R&D. "The InvestigatorDatabank can help expedite the process to achieve our most important goal—todeliver high-quality, effective novel medicines to the patients who are waitingfor them. We are enthusiastic about working with other industry leaders tocollectively apply our expertise, capabilities and shared passion for advancingscience and improving lives."

At the start of every clinical trial, pharmaceuticalcompanies have to go through clinical trial site selection, prequalificationand GCP training, which can be paperwork-heavy and time-consuming for trialsponsors and investigators alike, Janssen R&D notes. Theoretically, ifcritical information about investigators and trial sites is stored andorganized in one place, the databank will reduce time and costs for pharma andbiotech companies, making it easier for them to identify appropriate trialsites and investigators for future clinical trials.

As important as the bottom-line benefits may be tocompanies, the importance of reducing duplicative efforts for the sake of siteinvestigators themselves should not be minimized, notes Koester, estimatingthat two-thirds or more of investigators only do one or a few trials "and thencall it quits." He has suggested that part of the reason for this is burdensomedocument requirements, with investigators often needing to deal with manycompanies, each of which likely has completely different paperworkrequirements.

The Investigator Databank will not include patient data,Janssen R&D reports, and investigator sites that opt in to data sharingunder the program will have their relevant information accessible topharmaceutical companies participating in the collaboration.

As ambitious as this project is, it's really only part of amuch larger effort. Earlier in 2012, Janssen (or, more precisely, its parentcompany, Johnson & Johnson) joined with nine other top pharmas and putcompetition aside a bit to help form a nonprofit consortium—TransCelerateBioPharma Inc.—dedicated to accelerating the development of new medicines.Lilly is another member of the consortium, though Merck, as of the writing ofthis article, was not yet a member of TransCelerate despite being part of theInvestigator 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. andSanofi.

When the companies met to launch TransCelerate, theiroverarching goal in this largest initiative of its kind was to identify andovercome common drug development challenges with an eye toward improving thequality of clinical studies and bringing new medicines to patients faster. TheTransCelerate founders identified the centralization of site prequalificationand training as one of five key projects, and the Janssen-led InvestigatorDatabank project will serve as a foundation for that part of the TransCelerateinitiative.

"Industry collaboration, including pre-competitive datasharing, is critical to ensuring continued progress to improve industry-wideclinical trial practices," said the CEO of TransCelerate BioPharma, Dr. GarryNeil, a partner at Apple Tree Partners and formerly corporate vice president ofscience and technology at Johnson & Johnson, in the news release about theInvestigator Databank. "This work is aligned with TransCelerate's initial focuson clinical study execution and we encourage participation from our foundingTransCelerate companies to solve industry-wide challenges in a collaborativeenvironment."

Clinical trials are the "lowest-hanging fruit with thebiggest short-term payoff," Neil told ddnin October when interviewed about TransCelerate. "This really is aboutaccelerating innovation in drug development and getting more drugs to patients.What we are trying to do is shorten that timeline and make sure products areproperly tested."

Member companies of TransCelerate who wish to join theInvestigator Databank will automatically qualify for participation. The trio ofcompanies founding the databank anticipates that it will be operational by theend of the year and incorporated into one of the priority projects withinTransCelerate by mid-2013. The Investigator Databank will be hosted byDrugDev.org, an independent, third-party entity with expertise in clinicaltrial information technology and investigator community management.