Info & Opinion
April 25, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
In a major redesign of its flagship product for electronic data capture (EDC), Phase Forward has freshened up the user interface of one of the industry’s top packages. The changes are both cosmetic (no more red, green and yellow stoplight icons) and more structural. For fans of the stoplights, it's worth noting that some features of the older version can still be used. But the goal is to move the company's software toward a more modern look.
“The portal is updated to provide more information right off the bat,” says Rob Quinn, Phase Forward's manager of product marketing. He says the new version of the EDC software is the most extensive overhaul of the application in years. Which is a significant milestone, as the software made its debut in the late 1990s and, the company acknowledges, has not always been well reviewed for its look and feel.
For the first time, the tool is truly multilingual, allowing trials to be built in additional languages. The EDC system is also now agnostic about the Microsoft operating system, allowing the endangered species known as the corporate Apple user to sign into the program. There is also more ability to see operational metrics that might be needed by contract research organizations (CRO) or sponsor firms. Finally, the company has supported Japanese Kanji characters for years, but has tweaked that to allow hiragana and both full- and half-width katakana character sets for better display capabilities.
The trick during the user-interface redesign project was that the technology vendor wanted users to be able to continue to use the program without significant retraining. So, Phase Forward put considerable thought into new reports and views; fast drop-down-menu-driven views of the trial; and spiffier graphics that borrow a few hallmark traits from the Apple iPhone icons. The graphics have rounded corners, shadows and a barely visible arc in the center.
The new system made its debut at this week's Drug Information Association (DIA) annual meeting in San Diego. At the same event, the Waltham, Mass., firm is also debuting new tools for connecting clinical trial technologies owned by it and third-party firms.
Eschewing terms like "suite" and “eclinical,” believing they have too many amorphous definitions, VP for corporate development Martin Young says the company is still searching for a better word for what comes after EDC. “Our strategy is to ship an integrated set of solutions,” he says.
Although Phase Forward's recently acquired Waban Software division is traditionally considered a clinical data warehouse, Young says the company has already tied Waban into its EDC and patient-randomization tools. In database or application terms, they are two systems. But ordinary users may not experience them that way. Says Young: “You can randomize in either product. The information flows to either product. It's single sign-on. To a user, it appears as one product.”
To an outsider, it appears that the firm is quietly acknowledging some of the limits of its Clintrial tool, and tried to offer customers a quantum improvement.
For its part, the company says it is trying to carve out a broader position about how firms will work with large quantities of data in complex projects. "Clinical data warehousing is where the study data goes to rest once the study is closed and finished,” Young says. “That is very different than what this is about, which is while studies are live and pulling the data in.” The vision—and what customers increasingly request—is for systems that access data throughout a trial or pass it between systems.
Phase Forward has a utility for setting up trials in its system, and offers additional programs for storing clinical data, phone-and web-based randomization, drug safety and Phase I labs. But it says that customers are now sufficiently comfortable with EDC that they are seeking something ... more. “People are no longer looking at EDC as the solution,” says Young. “We think the focus has changed from EDC to automating this whole process. The game has started to change.”
During a trial, the handing of data between mission-critical systems can be complex, especially with oncology projects or other trials with prodigious amounts of lab data. At the moment, some handoffs are manual to a degree that would probably amuse veterans of the financial services industry, zapping billions around the globe. The life sciences aren't yet working so efficiently. “People are transforming data multiple times throughout the process,” says Young. “Some people put a bit into EDC. But that doesn't put it into the form you need it.”
No matter what analytical software packages are being used in the sponsor or CRO environment, Young says, Phase Forward would like to provide an environment to store the data for standard types of statistical analysis or further processing. “If you've got predefined SAS programs you want to run against it, you can import and it will run against those.” Such an approach presents obvious operational advantages (related to better trial management) and risks (related to the blind) but seems like a good first step toward realizing the larger potential of electronic data in clinical trials.