With Spotfire, Data Analysis Is Largely 'Self-Service'
By Deborah Borfitz

It is now easier than ever for physicians and research scientists to query clinical trial data and quickly get the answers they need to confidently proceed with, or stop, product development. The means is Spotfire Clinical Trials Analysis, an update of the original data visualization software (DecisionSite) of Spotfire Inc. that works on the company's new DXP data analysis platform.

The enhanced offering gives users the flexibility to do a guided analysis of clinical data, based on standard interpretations, as well as explore the information on their own, based on uncommon questions and fresh ideas, says Christian Marcazzo, senior director of life sciences analytics at Somerville, MA-based Spotfire. If trial data reveals problems with red blood cell count and blood pressure, for example, an investigator might choose to do an ad-hoc analysis to see if one event is predictive of the other or impacts only certain subsets of patients.

The ability to dig deep for hidden patterns, trends, and biases is imperative given the growing pressure on drug developers to "improve the productivity of R&D" and avoid costly, late-stage failures, says Marcazzo. Companies want to understand product safety risks during Phase I trials and, if the risks aren't enough to cancel the project, mitigate them via trial redesign in subsequent phases. They are also keenly aware of mounting public intolerance of safety-related incidents tied to new and developing drugs, and the desire of the federal regulators to be viewed as ever vigilant about the protection of human subjects.

Spotfire Clinical Trials Analysis debuted in March and has about 10, mostly big-pharma customers, says Marcazzo. Novartis and Organon (soon to be acquired by Schering-Plough) are among them.

Only in recent years have sponsor companies had the data infrastructure, notably electronic data capture (EDC) and clinical data management systems, to take full advantage of such a tool, says Marcazzo. Some companies have a data warehouse, making it particularly easy to configure Spotfire's new tool to retrieve and analyze all sorts of data. If not, the software integrates data from myriad sources - i.e., lab safety data in an Excel spreadsheet, demographic data from an EDC system, and efficacy data from a SAS file -- for purposes of analysis. "It's just a bit more work in the beginning."

Potentially "millions of rows and thousands of columns of data" can be loaded into the Spotfire product, says Marcazzo. Users get "quick ask-answer cycles" as they create graphs that respond to the addition (i.e., color by gender) or removal (i.e., patients on placebo) of different dimensions.

Much of this could be attempted without Spotfire, using statistical packages from SAS and Insightful Corp., but the wait between individual questions and answers might take hours or even days because it would require the input of a statistician or programmer, says Marcazzo. Standard reporting tools used by the information technology department also produce static reports that may produce more questions than answers. "[Spotfire has] more of a self-service model."

TrialStat Tightens the CRO Connection
By Deborah Borfitz

With the launch of CROFirst in April, Ottawa, ON-based TrialStat put a name on what it has been doing informally with mid-sized contract research organizations (CROs) for the past two years, according to president and CEO Jonathan Barker. "We transfer knowledge about how to use our EDC tool [ClinicalAnalytics, or CA] to users whose primary understanding is...not technology."

Because CA is a 100 percent software-as-a-service offering, there's no need to install software or hire programmers in the local environment, says Barker. Users can quickly configure studies with the assistance of easy-to-use wizards and templates. CA 4.0 can be deployed on tablets, personal digital assistants, and pocket personal computers with a single button click. It also provides integrated support for bar code scanning and image-based data capture.

CROFirst was created at the behest of client CROs, which integrate data-capture solutions in their competitive bids to sponsor companies, says Barker. "They tell us that they're more likely than not to win business with our platform."

Product training and certification are the only requirements, says Barker. The program is designed to increase new business opportunities for CROs through co-marketing and lead generation, product demonstrations, flexible pricing, an analysis of knowledge transfer and regulatory requirements, rapid deployment of EDC, and the availability of a full suite of data management services by TrialStat. CROs also have the option of being certified to take on data management functions themselves.

Nearly a third of all TrialStat clients over the last 18 months "have been engaged in activities like this," says Barker, and "a pleasing increase in interest" in expected over the next six to 12 months. "It's in our own best interest to make CROs successful. We don't see ourselves as anything but an organization that sells software."

CROFirst is a non-exclusive partnership program, says Barker, "but we are in discussions with clients [in Europe] about exclusive relationships and tighter connections. I hope to have a summer announcement about that."

Partnering CROs will be invited to sit on a newly forming CRO Advisory Board to help guide the program's initiatives and provide input into the evolution of CA, says Barker.

TrialStat reports having 60 employees, $5 million (Canadian) in venture funding, and a 421 percent year-over-year growth rate. Its product lines include SRS, the world's only commercially available systematic review platform.

At Nextrials, It's All About Standards
By Deborah Borfitz

Nextrials has created the industry's first standards-based interface for clinical trial patient recruitment and randomization, allowing hospitals' electronic health record (EHR) systems to troll for subjects matching study protocol criteria. "It's a huge opportunity to enroll patients more quickly," says Anthony Costello, co-founder and vice president of product development and data services.

"Enrollment is a big problem now," says Costello. "In 80 to 85 percent of all trials, enrollment is behind schedule. Yet patients and patient advocacy groups say patients can't find the protocols they need."

The new PRT module of Prism, Nextrials' flagship electronic data capture (EDC) solution, is designed to close that gap, says Costello. It's built on a native XML (extensible markup language) platform that accepts clinical data in any format and transforms it into the Clinical Data Interchange Standards Consortium's (CDISC's) Operational Data Model (ODM).

Data conversion to the ODM standard happens through a partnership with Raining Data Corp., whose TigerLogic Clinical Trials Data Services feature set is integrated with Prism. Once data resides in ODM format, it can be pushed to patient randomization systems and other data warehousing solutions, says Costello.

The module promises to reduce the need for more traditional recruiting tools such as direct mail and newspaper ads, says Costello. It will completely eliminate the need for an interactive voice response system for phone enrollment and duplicate data entry. "We're talking to several sponsor companies, as well as major EHR vendors, about doing a pilot later this year."

EHR vendors are especially excited about the pilot. "If we can help hospitals be better trial sites, those hospitals have part of their return-on-investment justification to buy [an EHR] system in the first place," says Costello. At present, only about 20 percent of hospitals use any type of EHR system.

Costello notes that much work has been done to create an interface between EDC and EHR, but the focus has been on electronic case report forms (eCRFs). "We think that's the less interesting piece. It's more important to find patients and get them enrolled. The logical next step [that the PRT module can also do] is to get the eCRF populated."

Prism has had a randomization piece since 2002, so only the patient recruitment component is new. Prism has also been in lockstep with the ODM standard for many years. CDISC has "worked diligently" to move along its four major sets of standards for data formatting, the collection of lab data, data submission, and eCRF design, says Costello. "By 2010, it wants all the models to coalesce into one big ODM model."

In the last year, CDISC has started the Clinical Data Acquisition Standards Harmonization (CDASH) initiative and a movement toward standardizing protocols in XML format, says Costello. "Those two initiatives, plus the ODM piece, told us the time was right for the patient recruitment tool."

Costello is involved in the CDASH initiative to standardize eCRFs by virtue of his being this year's chairman of the Society for Clinical Data Management. "Non-profits and government agencies [including the National Cancer Institute and the Association of Clinical Research Organizations] run the show," he says. The task is scheduled for completion in 2008.

"These sorts of initiatives have huge implications for companies like Nextrials," says Costello. "The more we standardize eCRFs, the more we cut the cost...to build study databases. We could design studies much more efficiently if everyone used standard eCRFs and stayed compliant with standards all the way through submission to the FDA [Food & Drug Administration]. That's the end-game for all of us."

CDISC will publish the first few standardized eCRF forms at its website "relatively soon," says Costello. As with ODM, it's up to companies to "use them heavily or not at all. But it's likely the FDA will eventually request these types of things. Even now, the FDA itself is getting closer to adopting the CDISC submission standard."

"In the near future, we'll be making CDISC standards even more central to what we do," adds Jim Rogers, co-founder and CEO of Nextrials. Version 2.8 of Prism, to be released in July, will be wholly in accordance with the CDISC ODM standard. Other EDC companies work with CDISC "around the periphery. We have the first software based 100 percent on the ODM model."

Nextrials reported more than a dozen new clinical trials were initiated using Prism in the latter half of 2006, including several multi-national trials.

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