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
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By design, electronic data capture (EDC) systems are utilitarian. Clinical data managers need a secure, electronic way to collect and change medical information. As such, EDC systems are about as scientific as a box of ballpoint pens.
But that could be poised to change with the unheralded purchase of a small clinical trial technology firm in France. At the end of 2010, Merge Healthcare of Milwaukee, Wisconsin, bought Kika Medical of Paris for a net price of $2.03 million in Merge stock, once reserves for potential future litigation and other withheld shares are tallied up.
Jon DeVries, general manager of the eclinical division at Merge, notes that Kika's EDC package includes the ability to adjudicate clinical endpoints. Although several technology firms and contract research organizations (CRO) can provide endpoint adjudication services, DeVries says that Kika's solution is uniquely embedded in an EDC package and comprehensive—wrapping up the process in an end-to-end way that can be audited and reviewed by regulators.
Endpoint adjudication, in simple terms, is a rigorous, blinded, case-by-case assessment of whether a particular patient has reached a major statistical milestone. It is a seriously clinical and scientific undertaking. "They can also be used in a number of other key clinical trial decision-making processes: power calculations, periodic safety reviews by data safety monitoring boards (DSMB), sample-size re-estimations and other interim analyses, next stage progress for adaptive design trials and study completion for event-driven trials," says DeVries.
European and U.S. regulators, vexed by a profusion of industry approaches to diabetes research, are now requiring adjudication for cardiovascular endpoints in that therapeutic area. So DeVries believes that functionality in the Kika system will prove useful in growing his business. "That was one of the gems that we got in the acquisition," DeVries says.
Endpoint adjudication can help prevent discrepancies between assessments of the same patient at different locations, i.e. the investigative site and a DSMB. Those issues have cropped up in some high-profile trials, and regulators on both sides of the Atlantic are trying to prevent such problems in the future.
To date, FDA comments on endpoint adjudication have largely been about the process itself, not related to computer systems supporting it. But the role of technology has not entirely escaped the agency's notice. It's clear that the FDA regards endpoint adjudication as something that could ease the labors of its inspectors.
"On-site inspections related to endpoint adjudication may be warranted under certain circumstances," the FDA noted in this October 2010 policy manual. "It is often not feasible or practical for the [FDA] clinical review staff to receive clinical source data for an audit (e.g., the large size of the electronic files may overwhelm the FDA’s ability to receive or store them); therefore, the clinical review staff should request electronic remote access to the clinical source data whenever possible."
Beyond the FDA's comments on the topic, scientists at Merck and the University of Texas wrote this 2009 article in the journal Clinical Trials. Zaher El-Assi, a Kika executive, will be joining Merge and wrote this 2010 article on the topic for Applied Clinical Trials. It will be interesting to see whether major EDC suppliers shrug off endpoint adjudication as a curiosity, or quietly work to duplicate Merge's capabilities.
The clinical trial business at Merge includes the former etrials system, which was acquired in 2009. DeVries says Kika is bringing in new types of customers (in orthopedics, medical devices and registries). And it adds to the firm's geographical reach, which includes a big office in the North Carolina biomedical complex. "This opportunity gives us a presence and sales team in Europe," DeVries says, adding that the EDC sales process might be a bit more relationship-based across the Atlantic.
With the etrials heritage and Kika's customers, Merge has assisted on 1,000 trials in 65 countries. DeVries says Merge is currently working with six of the 10 largest sponsors, six of the 10 largest medical device firms and six of the 10 largest CROs.
How long will Merge support two EDC platforms? A while. "We won't be end of life-ing either of them," DeVries promises. "It will be a convergence." Over time, he explains, customers for Merge and Kika will be queried on the features and functions that matter most.
In general, he adds, Kika and Merge's eclinical group are both enjoying robust growth of late. In addition to randomization and patient diary solutions, Merge is selling integration and imaging-related software and systems to hospitals and large physician groups, having previously done business with 1,500 hospitals, 800 orthopedic imaging centers, 2,200 outpatient imaging facilities and medical equipment manufacturers.
DeVries says the company's existing showcase for its portfolio, in Chicago, will be replicated in Paris to show prospective customers how all its solutions fit together. Public financial filings suggest the firm had $113 million in revenue during the most recent fiscal year, but it doesn't divulge trial-related revenues.
The idea behind the imaging system is that some of the most sophisticated radiology groups in clinical trials need not sweat the details of transporting, managing and storing hundreds of images per project. Says DeVries: "We enable a CRO to apply their core competence—their data, site and project management expertise—on our platform. We're also gaining traction with core labs that are therapeutic thought leaders, not necessarily technology shops."
Merge also offers an expedited, simpler version of EDC that allows almost any sophisticated clinical trial manager to quickly build a database and launch a study. That web-based software, called MyEDC, was introduced as recently as the summer of 2010, but is already attracting users for simple studies that don't require custom programming. "For a large segment of the market, we think MyEDC will be a very compelling solution," DeVries says.
Some projects using his expedited EDC system will price out at between $15,000-30,000, perhaps a tenth of what big systems cost. Since those fees are entirely usage-based, the sponsor that knows a trial's duration can anticipate the exact cost of the technology for the project.d9A2t49mkex
One large CRO wanted to see for itself whether the simpler EDC system was truly adequate for its needs. The CRO built a trial identical to one run on a larger, better-known system. "They built it themselves in two weeks for ten percent of the cost of a full-service solution," DeVries notes.
Editor's note: Here's a 2010 article on Merge's approach to imaging.