The good news is: cloning works. The catch? You have to rethink your most cherished and convoluted case report forms (CRF).
Barely two years ago, CDISC president Becky Kush, the well-travelled and uber-diplomatic Henry Kissinger of the clinical trial realm, located ... a replica of herself? In Scandinavia? No, just someone equally savvy and inclusively collegial.
That would be industry veteran Rhonda Facile. She is the keynote speaker on a free webinar with our friends at TrialStat! tomorrow.
The webinar topic: CDISC’s Clinical Data Acquisition Standards Harmonization (CDASH) effort. The organization had input from 190 people, 30 of them actively. CDASH traces its history to the Association of Clinical Research Organizations (ACRO). That effort lagged.
Then FDA stepped in, trying to rouse a narcoleptic nation to the Critical Path initiative. Janet Woodcock herself blessed the CDASH concept at the 2006 Drug Information Association meeting. FDA persevered in an advisory role, but CDISC took over the project. Facile relocated to Texas from a job in Sweden.
Many people know CDASH will revamp CRF design, with standard buckets for adverse events, demographic and other common types of data. But Facile helps a reporter appreciate that the crux of the effort is not about a particular font or check box on a CRF. No. You can use whatever layout you want with CDASH, whatever color of paper. Really. CDASH will only suggest an order for different standardized fields on your forms.
Follow The Meta Data
CDASH, indeed, is about content. In other words, meta-data. Not reinventing an endless number of
CRFs carved stone propulsion systems called wheels, which is what the industry does thousands of times a month. The first public peek at the CDASH standard will be this spring. Life could get just a bit easier in the clinical trenches.
“These are the basic data collection fields,” notes Facile. “This is a huge step forward.”
One Good Way
Facile points out the sheer profusion, the mind-boggling diversity of CRFs that collect the same biomedical data. This creativity creates extra cost and delay. How many sponsor organizations, after all, have bogged down in discussions about how to capture a type of data that every trial must record? As a clinical person, Facile can personally attest that sites and investigators also struggle under so many subtly different forms to collect the same data.
So, to repeat, the CDASH effort is not going to mandate the look and feel of a particular CRF. Instead, it’s defining how the fields and data in that form should be mapped to a database and, eventually, funnel into the CDISC Study Data Tabulation Model (SDTM). (It’s worth noting that CDISC holds a special FDA license to sprinkle high numbers of acronyms through its documents and presentations.)
SDTM, for the uninitiated, is worth paying attention to. It’s the way the FDA plans to eventually require sponsors to submit clinical data for review. So if you implement CDASH form correctly, your downstream worries to generate the proper CDISC-blessed data files for submission should be as painless as possible.
Mark Wheeldon of Formedix is also speaking on the TrialStat! webinar tomorrow. His firm, where he’s CEO, is doing a brisk business in CDISC-related consulting and software. Wheeldon believes such work is already creating a novel, hybrid category of service-oriented technology firm (or is it technology-savvy contract research organization?). Formedix is working on ways to link CDASH, other CDISC standards and the offerings of major electronic data capture vendors.
Wheeldon believes the CDASH effort will save sponsors copious time and money, perhaps as much as 40 or 50 percent of what is needed to start trials. “If your forms are aligned with your submission data set, you map them once and you don’t have to worry about them again,” says Wheeldon. “You can use CDASH as a sort of rule book.”
He speculates CDASH could be especially powerful at smaller firms. No previous knowledge of CDISC is required, he says. “The guy running trial design just goes to grab CDASH forms off the shelf and they’re ready,” says Wheeldon. “He doesn’t have to learn about CDASH.”
Just as it’s side-stepping any mandates on the cosmetic aspects of CRFs, CDASH is staying away from therapeutic area nuances. It make sense. If leading cardiologists or neurologists can’t agree on basic terms and concepts, it might be difficult for a nongovernmental organization like CDISC to distill such domain knowledge to a standard. Which is not to say CDISC or other parties might never take a crack at therapeutically specific CDASH standards later.
You Can Sound Off
For now, the next step is for CDISC to release, before the summer, a public version of CDASH. Facile expects that release to draw plenty of comments. The CDASH team will duly consider them. During the summer, Facile predicts, it might be possible to start planning a live trial that uses CDASH standards.
Says Facile: “We hope to get quick and comprehensive feedback on the standards by early implementers as soon as possible. The most useful feedback will be acquired once people start actively using the standards.”
We asked Facile how she has shepherded such a potentially unruly project toward its birth. “Communication is very key. I try to make sure we have a tone that allows that and encourages that,” she says. “You do have to be diplomatic and listen to what’s going on. At the end of the day, when you have two solutions that are equally good, you have to go with one. I try to make it palatable and easy to do that.”
CDASH, in some ways, is a form of eclinical carbon, a keystone molecule. It’s a foundational element from which much more complex clinical trial molecules can be built. If it’s implemented properly, and rigorously, CDASH promises significantly faster trial set up times, and significant financial savings.d9A2t49mkex