EDC at JNJ, Part I: A Sponsor Ahead of the Cutting Edge

Wizards of clinical trial technology can take hours explaining why electronic data capture (EDC) only works in Phase III trials with a thousand patients. Only then, the conventional wisdom holds, can the costs of using computers be recouped.

So it was refreshing to chat with Debbie Kennedy, associate director of global clinical operations at Johnson & Johnson (JNJ). Kennedy is based in the UK, and is planning to use EDC, not paper, in the vast majority of the company's trials in Phase I, which are run out of 13 sites in six countries on three continents. Some of her studies have a dozen patients and average 45 patients or so. "The number of subjects makes no difference to us," she says. That's a rare statement, with the rest of the industry shunning EDC in small trials.

At JNJ, there was never any plan to use EDC as an isolated fix. To her, EDC is principally (75 percent) a matter of process change and only incidentally a technology (25 percent). "What we really started to do in 2002 was look at developing an end-to-end process," says Kennedy. "We wanted a collaborative approach to introducing EDC into the business."

Says Kennedy: "It's not down to one group to say: 'We want to do EDC, everybody else has to fall into line.' We wanted a collaborative approach. We were very aware that this wasn't a quick fix. If we wanted to introduce EDC into the business, we needed inputs and buy-in from all the stakeholders for it to be successful."

With more input, of course, there was more resistance. "Obviously," says Kennedy, "a lot of people are opposed to change. They are worried about their jobs, whether they are going to have to learn a new skill. There were a lot of people who did resist EDC. The majority were on the clinical and investigator side."

Let's be candid. Organizational hostility to technology remains a force to be reckoned with in many companies. But Kennedy exploited it. "We got those people involved. Those people who were really against us – they were the ones we got into the workshop. We got the critics involved. We said, 'Come and join us. Bring your concerns to the table.' We worked with these people. We used their thoughts and ideas and turned them around. It was like reverse therapy."

A handful of hybrid and paper studies may always be part of the mix of three dozen or so Phase I trials annually. But the default setting is to do a study not just with EDC, but with no paper source documents. That's known as e-source. "The majority of the data is entered directly into the system," Kennedy explains. "We really don't have a lot of pieces of paper floating around."

To deliver e-source, Kennedy's group at JNJ is using wirelessly networked HP-brand tablet computers at the patient bedside to gather trial data with nary a paper form in sight.

Needless to say, JNJ's regulatory team examined the arrangement and found no issues, although there may have been a few informal consultations with the FDA to make sure everything was kosher.

One key to the picture is that clinical data is never stored on the tablets but relayed immediately to a server installed at the clinical site. Then that data is automatically replicated to another, central server at 15-minute intervals. All that facilitates those on the road and at other JNJ locations who need to inspect the data, Kennedy notes.

The HP tablets display what appears to be a paper case report form (CRF), except that edit checks and other functionality is built into the "form" on the screen. "We went from very simple checks to quite complex checks, which are built into the system," says Kennedy.

Kennedy offered a glowing testimonial to her vendor, Phoenix Data Systems, out of Philadelphia. That company, it turns out, was not the first choice of JNJ for its Phase I work.

The unnamed initial victor of JNJ's vendor selection process, Kennedy reports, irked the pharma with unexpected financial demands. "Every time we reached a milestone, we needed to pay more money," says Kennedy. In short order, the first vendor was fired and a replacement was sought.

At that point, JNJ got back in touch with Phoenix Data Systems. The Big Pharma was stunned to hear that the rejected vendor had, shockingly, taken its criticism to heart. Changes were made. "Phoenix Data Systems was the only company that had taken on board everything we had told them," Kennedy says. "We really developed a partnership. It wasn't a client-customer relationship. We have an absolutely excellent relationship with them. They are extremely flexible."

For her part, Kennedy says, e-source is not a provisional novelty at JNJ. It's the way her group does Phase I research. "EDC is business as usual," she says. "It's not something we're experimenting with."

Here's what it boils down to. Considering an entirely separate e-source project with another vendor, JNJ is the clear leader in using advanced software in Phase I trials. It is not incidental that those trials are the very ones that many observers thought would be the hardest to accelerate with technology.

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EDC at JNJ, Part II: A Vindicated Vendor's View

The founders of 59-employee Phoenix Data Systems and the CEO, William Claypool, came out of SmithKline Beecham.

So the people at Phoenix Data Systems can be forgiven if they occasionally remember life on the sponsor side of the table. "The change orders and the cost overrides always seemed to result not only in a lot more money but in tremendous delays while the vendor was making up their mind about how much they would gouge us," Claypool says.

A pulmonologist, he managed 34 regulatory filings and supported almost two dozen pharmaceutical product launches before taking over Phoenix Data Systems. Claypool believes the company's approach is different: "We really owe it to our clients to be their partners. We want to give the clients a fair price at the start."

"Our sweet spot continues to be small and mid-sized pharma," continues Claypool. "We love working with Big Pharma when they approach us, but it's not the major focus of our effort."

In some cases, he reports, contract research organizations (CROs) are more interested in the status quo than in using new technology. Certain sponsors of trials have confided that their CROs have nixed the usage of EDC. "In many cases," says Claypool, "we have heard the story that their CRO partner does not wish to use EDC and would prefer to stay with a paper-based approach."

His uninflatable pricing, Claypool explains, is rooted in the solidity of his technology. "We know our processes, our technology, our costs," says Claypool. "We know how long it takes to make changes and accommodate a client's needs. Our pricing is extremely modular and transparent. We do not charge for data transfer. The client has the data available all the time." Change orders received on a Friday afternoon, he says, are typically finished by Monday afternoon.

Claypool is also proud of the reports his system can generate, which vary according to the privileges of the user. "We can create reports with a variety of filters. Some of those filters are obvious to the user, and some are not," he says. It's easy to drill down from the portfolio of trials, to one trial, to one site, to one patient.

One chart, with predicted and actual events, is especially popular. "They make it extraordinarily easy to see what is going on in a clinical trial or a group of clinical trials," Claypool says. The company is happy to discuss custom reports with customers but – to keep an eye on its own costs – will monitor how often a custom report is actually used. Infrequently used custom reports will be pointed out to customers, he says.

For Claypool, e-source is not controversial or cutting-edge. "We recommend e-source in very busy Phase I trials, and that has worked well. We also recommend it in out-patient studies," he says.

Claypool believes a long-awaited, elusive consolidation in the EDC industry may be at hand. "There is a growing acceptance of these technologies," he says of customers. "It's not a matter of whether they should use it, but how they will deploy it. The acceptance of EDC may come faster than some of the earlier predictions."

MedNet Solutions: "ERO" from Minneapolis Specializes in Device Trials

Ah, the heartland. America's flat Midwest has more than its share of modest, self-effacing souls of Scandinavian heritage. As a result, the region is genetically disadvantaged when it needs to promote itself.

That could explain how Tim Pratt, a joyful and not-very-bashful Australian, wound up at MedNet Solutions of Minnetonka, Minnesota. A management PhD, he's both the chief marketing officer and the principal scientific adviser at the 30-person company, which was founded in 2001. "Some of our people have worked together for 25 years, always on clinical databases," says Pratt.

"We call ourselves an E-R-O," Pratt adds, meaning "electronic research organization." "We bring together technology and the aspects of a CRO needed to support that. We've never done a paper study. We never want to." The company believes that data security is enhanced when paper is made obsolete.

Pratt would rather MedNet Solutions not be lumped in with other CROs, thank you. "A lot of CROs have bad reputations with sponsors," he says. "Not delivering or grossly underbidding."

Some 23 trials are under way, ranging in size from 500 to 2,000 patients. The price for a typical project often falls in the range of $200,000 to $380,000. Customers have included Guidant, Boston Scientific, Medtronic, and St. Jude, as well as Abbott Laboratories, Bayer and AstraZeneca. 

"We steer clear of saying we're an EDC company," says Pratt. "EDC is just an element of it. We do custom programming." It also does much of what a traditional CRO would offer, as the company's list of services illustrates.

 

In one assignment, the company wrestled with a language called Qnx, which was developed for thermostats but found its way into implantable cardiac monitoring devices like pacemakers. Such monitors churn out reams of data.

Pratt says MedNet Solutions figured out a way to extract data from such devices – and store and display it for clinicians and sponsors. "Until we came along, they couldn't look at their own electrocardiograms," Pratt notes.

With pacemakers and cardiopulmonary gas exchangers, translating the raw data from multiple formats into a graph is one challenge.  Displaying it is another. In those cases, XML was helpful.

Without hesitation, he agrees with a question about whether the company's technology can offer a no-frills version of a clinical trial management system (CTMS. "If you were to take all the things we offer and run them across the board on all your studies, you essentially have a CTMS in front of you," says Pratt. The company's system can track and ship drug supplies, analyze trends across multiple studies, and manage documents and staff scheduling.

It also manages payments, allowing site-by-site flexibility to pay certain sites a bit more or less. The system keeps track of contractual or procedural milestones and (after manual review) sends a request for a check to SAP or other financial systems. That feature alone saved almost three full-time employees at one large device manufacturer, Pratt says.

The company makes a point of not holding customers over a barrel. Like Phoenix Data Systems, described above in this newsletter, MedNet Solutions strives for no-surprise contracts. Pratt recounts a major EDC company that charged $25,000 for a two-week shutdown of an EDC study to correct a sponsor's error in setting up an erroneous validation between two data fields.

Says a rueful Pratt: "I'm aware of one instance at Medtronic, where they needed to correct two spelling mistakes and one data field. [Another vendor] charged them $80,000. That's the sort of thing our competitors get up to. That's why people get upset."

On a positive note, Pratt says, customers appreciate MedNet Solutions' speed and predictability. "We can get up fairly quickly. It's not hugely expensive. We don't charge enormous amounts for change orders. We can get things changed in a matter of minutes in some cases. We don't need to take the site down."

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