Info & Opinion
March 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 2011, with electronic data capture (EDC) systems in broad usage, there is only one deep question about the technology that remains. To wit: should EDC be confined to merely gather and clean data? Or should it also facilitate complex operational decisions while trials unfold? Just getting EDC to talk to other clinical systems can be a challenge.
“We've been working on this problem for many years,” says Peg Regan, president and CEO of PharmaPros. Her Boston-area firm can easily display data out of three top EDC systems (from OmniComm, Medidata and Oracle). Just as a jetliner’s instrument panel shows a pilot what he needs to know, PharmaPros builds clinical cockpits with data from systems for EDC, imaging, randomization, monitoring, safety, lab results and patient diaries.
In all those cases, PharmaPros specializes in presenting operational data. (Here’s an earlier ClinPage article on the company.) By analyzing a study protocol, and learning other key details of the company’s approach, PharmaPros can help customers know that an anticipated patient never appeared in the clinic, or that a scheduled batch of data never materialized.
A few months ago, the PharmaPros system impressed the judges at the Society for Clinical Data Management, who analyzed one of the company’s cockpits for a medical device manufacturer. (Here’s a link.) “This hasn't come overnight,” Regan says. “We have been trying to solve this problem for years.”
Another PharmaPros project is helping to integrate four parallel registries. Two of the post-approval studies are using EDC; two are relying on paper case report forms (CRF). Spanning five years, the research is scheduled to recruit approximately 6,000 patients in the U.S., Europe and Asia. Each of the four studies will be in 30 countries and have 200 sites. PharmaPros will present the data from a randomization system, central and specialty labs, a clinical data management system, scanned paper case report forms and a legacy clinical trial management system (CTMS).
Data integration on such a scale remains rare. PharmaPros says its technology is battle-tested and ready for sponsors to implement quickly and inexpensively, especially in comparison to integration efforts that take longer than the trials they are supposed to support.
The fact is, alas, that many sponsors of clinical trials use fountain pens and Microsoft Excel to keep track of a trial's progress. Such firms resign themselves to the mind-numbing drudgery of inkwells and spreadsheets.
No matter how many rows and columns it may contain, a spreadsheet will never directly communicate with all of the systems for a single modern trial, much less a portfolio of global research. PharmaPros’ system, by contrast, can automatically pull data from every connected subsystem on an hourly basis, eliminating the need to worry if a particular data element is fresh or rotten.
Spreadsheets can lead to galactic blind spots. How many patients in your pivotal Phase III trial have failed to qualify for the trial? Stopped participating? How many weeks did your team need to compile that information? Is that report still correct?
Regan recently spoke to a large, sophisticated research sponsor that had several huge blind spots. “They didn't know where they were,” she reports. “How were the sites performing?” A quarter of the company’s 350 sites on one trial had not recorded data or recruited a single patient in half a year.
That company is not alone. Running shoes and toaster ovens are probably brought to market with more granular project management data than most clinical trials. “The cost of projecting and planning on that and making sure those sites are performing can be quite large,” Regan notes. “The visibility is, I think, priceless.”
Clinical visibility may be easier to achieve with large EDC suppliers. Three large firms (Oracle, Medidata and OmniComm) have serious, prebuilt packages to connect to other eclinical tools; rivals are working on their own versions. But perhaps 95 percent of clinical trial technology suppliers lack the resources to build a commercial-grade application programming interface (API).
Linking Homegrown Systems
Even without an API, it turns out, PharmaPros can display your data—as long as it resides in an Oracle or SQL Server database. Later this year, it sounds like PharmaPros may roll out a new service to inexpensively create an API for any clinical technology supplier. Indeed, Regan says some sponsors have begun to ask about APIs from technology vendors. Are you developing an API? could be a revealing question to put to any vendor.
A PharmaPros' cockpit is a cleanly designed, intelligible collection of data with as many gauges, lights and dials as a sponsor needs. Regan says her firm often finds itself extracting data from internally-developed systems behind a company firewall.
Help from CDISC
Part of the clinical visibility challenge, however, is not technological. It’s cultural. PharmaPros struggles less when the underlying data have been structured according to the Clinical Data Interchange Standards Consortium (CDISC) operational data model guidelines. And because adherence to CDISC guidelines is not required by the FDA, sponsors need progressive, forward-looking outlooks to embrace CDISC.
Regan says adherence to CDISC helps PharmaPros’ clients see what is happening in the real world. She believes higher visibility could confer competitive advantages. It’s not so much that PharmaPros is creating a vast new data repository; it leaves that task to other firms. Rather, its system is tuned to determine such details as when the data for patient AR39184 was supposed to arrive vs. when the data actually arrived. Replicated thousands of times, that gives a sponsor an unprecedented, reality-based assessment of where big projects stand.
For many sponsors, with multiple organizations participating in every trial, it has become difficult to know if the project is on track. A good EDC system, naturally, will tell a sponsor about much of the raw data. But a full picture of the project typically requires data from five or ten other systems that the EDC system may or may not be connected to.
There are also psychological aspects to the PharmaPros customer engagements. In some cases, Regan and her team function as social workers, consoling clinical trial managers who rub their eyes in disbelief about the numbers on the dials in their new cockpits.
Which is funny. PharmaPros doesn’t create data. It only displays what a client is already gathering. Even so, Regan says, clinical pilots can be alarmed when they see the altitude numbers for the first time. Says Regan: “They are incredulous. They are like, ‘This cannot possibly be. You've entered the wrong information.’ ”
Not really. The data generally flow to the cockpit automatically or in batches. Says Regan: “We're not entering anything. We're reading it all. Is the data complete? Is it accurate? Are you done?”
After the shock wears off, she says, there can be a daunting list of tasks for organizations that are glimpsing their actual operational statuses for the first time. But like a cold splash of water in the morning, reality can be refreshing. Once the various clinical trial systems are feeding the cockpit properly, the true operational status of the trial, triumph and tragedy included, comes sharply into view.
“At least now they will see that status instantly,” Regan says. “You have to allow it to digest. It can be scary.”
PharmaPros is occasionally working for contract research organizations (CRO) as well. CROs are traditionally more circumspect about divulging status information to sponsors, but Regan says that is changing. The PharmaPros system can be configured to have partial views of some data if the CRO so specifies.
Especially smaller CROs, she says, understand that it might be good to avoid having an unpleasantly surprised client. Data can help avoid that. “They don't want to open it up completely,” Regan notes of the clinical cockpit. “But the more progressive CROs do want to enable that enlightenment.”
Regan’s son, PharmaPros director of business development Brion Regan, points out that many companies using Excel or other antiquated managerial tools may not understand how quickly clinical trial data become stale. And unlike custom-built, server-based software, the company’s technology runs via the web, meaning that clients have no software to install or maintain. To use the IT jargon, it’s in the cloud or software-as-a-service (SAAS).
Brion Regan predicts that big clinical trial technology vendors will increasingly be obliged to open up their systems, developing an API or partnering with other firms. “To be successful in the future, you will need to be able to exchange data openly with any other system,” he says.
In some cases, the PharmaPros system allows a single individual to manage more trials more intelligently. One person using the PharmaPros technology can do the job of several managers relying on Excel. How? Rather than darting from one system to another, like a squirrel, grabbing a few nuggets of data here and there, PharmaPros provides a more unified, comprehensive view. That saves time.
It also gives a smart human the latitude to think. “Throw out your Excel spreadsheets,” he says. “People are expecting Excel to be something it was never intended to be.”