Electronic Data capture Paperless Trials: Fact, Fiction, or a Little Bit of Both? EDC has gone through many iterations in the past couple of years. While the technologies and processes have evolved significantly from the early days, the move to a completely paperless environment is still a long way off. To gain the efficiencies that EDC offers, companies will have to decrease their dependence on the paper trail and move beyond the pilot phase. By Denise Myshko No one doubts the benefits EDC can bring to reduce queries and shorten the time to database lock. Intuitively, people within the industry understand that electronic data capture can lead to better data faster. But work processes within the sponsor environment are so interconnected in the conventional paper clinical-trial arena that implementing new technologies often is an uphill climb. For some companies, EDC may not have lived up to their expectations. The technology may have cost more to implement than was budgeted; it may have taken longer to implement; training may have been more involved than was planned for; and the extent to which work processes needed to be changed may have been underestimated. “EDC requires people to change the way that they work,” says James Langford, president of DataLabs. “There were work processes behind EDC, and I think people either didn’t recognize this or minimized the process changes that were involved. Many people believed that they could gain the benefits of EDC and still use the same process they had been using for paper data capture and data entry. But EDC uses different technologies and requires different processes. I think this is where the early users of EDC found it did not meet their expectations.” What is needed is a different philosophy by pharma sponsors and technology providers, says Gary Gabriel, Ph.D., VP of strategic marketing at LifeTree Technology LLC. “Technology providers have to become more total-solutions oriented to help companies be successful,” he says. From a technology standpoint, Adrian Hsing, director of clinical data management at Gilead Sciences Inc., says a truly paperless environment allows companies to source data electronically, which is a huge advantage. “As a sponsor, we want the data as soon as possible,” he says. “Suppose, for example, the calcium and sodium values are reversed. We will catch the discrepancy when we do an edit check. But that same error could have been caught if the data were captured by the system right away. The older the data are, the more expensive the information is to clean up.” EDC has been helpful as a data review tool, but the technology hasn’t eliminated paper processes, according to Judy Sromovsky, senior director of data management and clinical systems at The Medicines Company. “There is still an abundance of paper and will be for some time,” she says. “As the next generation, who are less dependent on paper, enters the workforce, this may change. They will not have the need to print everything the way we still feel we do.” For many companies, the adoption of EDC is still a leap of faith, says John Cline, CEO of etrials Worldwide Inc. “But once companies commit to a pilot program, more often than not, they will rapidly move toward full-scale adoption,” he says. “And then they want to know how they can begin to integrate other data.” EDC in Practice Even though pharmaceutical companies are moving past the pilot stage, this step has taken some time, and there is still a long way to go. The percentage of companies using EDC in trials will grow from 7% in June 2005 to just more than 18% over the next 12 months, according to Life Science Insights. Another 30% of companies are expected to begin using EDC in 50% to 90% of their trials in 12 months. “For 10 years we have been investigating EDC, and at this point we have had a pilot program in every therapeutic area using a host of different technologies,” says Brad Gallien, director of life-sciences industry strategy at Oracle Corp. “The ROI has been proven; we are getting cleaner data faster.” “Once companies understand the technology and bring it in-house so that they can incorporate EDC with their internal systems and processes, they are finding efficiencies in other areas beyond database lock,” Mr. Langford says. “Moving from one study to the next can be done very rapidly, and a company will gain additional efficiencies in the flow of information from the EDC system to its existing systems, allowing better business decisions.” William D. Claypool, M.D., CEO of Phoenix Data Systems, says savings come largely from efficient query resolution. “Those savings would translate further for many companies if they would embrace full-service data management,” he says. Mr. Hsing says Gilead Sciences is using a virtual clinical data management model. “We have reduced our operation costs by 30% using this model,” Mr. Hsing says. “When people talk about clinical data, they’re thinking about data in the database. My question is, why do we need a physical database in-house? I can live with a physical database anywhere in the world as long as I have a secure connection to the system. We have our EDC partner extract the data every night and put the information on a secure FTP server. Then we download the data into our server in a SAS format.” He says the company has shortened the time from last patient visit to database lock by 45%. CROs coming on board Because more CROs are being asked by their sponsors to provide both paper and paperless bids, they too are entering into strategic partnerships with technology providers. “More CROs are now engaging in EDC,” Dr. Gabriel says. “Some CROs are in a fairly advantageous position because they have a history with a spectrum of activities supporting clinical programs. As pharmaceutical companies become more accepting of automated data-capture technologies, they will also see some CROs as the right vehicles for their success with EDC.” The Life Science Insights study found that pharmaceutical companies’ review of operating costs of CROs will force them to develop stronger relationships with EDC vendors. CROs are adding EDC competencies, but are also pursuing multiple technology partnerships with leading systems. Additionally, homegrown trial-management systems are increasingly being replaced with packaged and ASP solutions, and vendors must work to differentiate their offerings and licensing programs. Filling in the Gaps Mr. Hsing says one thing missing from current EDC systems is a way to authenticate who has made changes to data. In the near term, he says Gilead Sciences is planning to implement an authentication process for its EDC systems. “At this point, I don’t know of any EDC vendors that offer biometric authentication,” he says. “We are looking into voice authentication, which is one phone call away.” Cost is another factor, according to experts. “Emerging biopharmaceutical companies may not be able to afford the price tag of some of the top three or five EDC players,” Dr. Gabriel says. “But the technology has become much better, and pharmaceutical and biotechnology companies can now purchase extensive EDC capabilities and functions for much less than even a few years ago.” Greg Johnson, VP of global data management at PRA International, says two to five years ago, many of the impediments to implementing EDC were more technical in nature. “Today the main impediment for the adoption of electronic data capture is a business model that works for delivering the services,” Mr. Johnson says. “A delivery model needs to be in place for EDC to be cost-effective earlier in the process. When companies change major functional processes, there is an associated learning curve. A company won’t realize the full advantages of EDC until it repeats the process two or three times with the same players and people develop the appropriate skills.” Mr. Cline says the next step for many companies will be integrating the data with other systems. “Companies are now starting to ask about how they can connect their data to other systems, for example to lab data, or connect image data into EDC,” he says. “This is the same type of business evolution that happened many years ago in the EDC space when it first appeared on the scene.” PharmaVOICE welcomes comments about this article. E-mail us at [email protected]. Adrian Hsing The ability to provide viable e-source data that is one click away will be another advancement for EDC companies. Dr. William Claypool Better control and visibility of study data allow sponsors to manage every aspect of their trials more efficiently, from enrollment to adverse experiences. John Cline A paperless environment is going to require a convergence of forces to move people out of their comfort zone. Once regulatory pressure is applied to have real-time access to data, people will start to adopt EDC in droves. PharmaVOICE October 2005 Greg Johnson EDC is at an inflection point. There are many people, both on the sponsor and CRO side, who now view EDC as something they and investigators want. The industry will begin to witness a sharp uptake in the number of EDC studies going on. The ABCs of EDC: A Tool Box of E-Clinical Solutions n Clinical data management systems(CDMS): Secure data repositories for clinical-trial data, with audits and controls as required by the FDA. They include design tools for structuring the database consistent with trial design. Reporting and query capabilities are often included. n Drug safety monitoring: Tools for logging, tracking, and reporting adverse medical events during drug trials. n Electronic data capture (EDC): Applications for capturing clinical-trial data from patient encounters at the investigator’s site. These include design tools and real-time edit checks. n Electronic patient diaries: PDA-based applications that allow patients to report quality-of-life and other information as part of a clinical trial. n E-submission tools: Modules for formatting and delivering clinical data as part of a regulatory process. They include support for standards such as eCTD. n Interactive voice response systems (IVR): Tools used for trial management, patient enrollment, supply-chain management, and data access. They also meet regulatory requirements for capturing self-reported patient data. n Investigator management systems: Tools that build and manage a pool of past and potential investigators to accelerate recruitment. n Site management systems: Tools used by site managers to monitor the activity of investigators at a large site, including contact information, schedules and milestones, and financial budgets. n Trial management systems: Tools used by trial sponsors to track the progress of clinical trials –from set up to investigator payment. n Vocabulary management systems: Software tools that include clinical vocabulary to a standardized set as defined in the trials protocol. These work with CDMS and EDC modules. Source: Forrester Research Inc., Cambridge, Mass. For more information, visit forrester.com. James Langford The adoption of standards is accelerating, and this is being pushed by the FDA. When the standards are formalized, then there truly will be a way to integrate and communicate seamlessly with all of the systems that are involved in a clinical trial. Brad Gallien There is going to be a continued drive toward usability and efficiency in the deployment models of EDC. Once this happens, an increasing number of companies will look for true global implementations across a majority of their trials. Experts on this topic William D. Claypool, M.D. CEO, Phoenix Data Systems, King of Prussia, Pa.; Phoenix Data Systems delivers cost- effective electronic data capture and data-management services that give clinical-data managers improved control to run well-managed studies. For more information, visit phoenixdatasystems.net. John Cline. CEO, etrials Worldwide Inc., Morrisville, N.C.; etrials is a software and services company that offers fully integrated, easy-to-use e-clinical software for the clinical trials process. For more information, visit etrials.com. Gary Gabriel, Ph.D. VP, Strategic Marketing, LifeTree eClinical, Temecula, Calif.; LifeTree eClinical is a member of the FFF Enterprises Inc. family of companies and offers a suite of clinical technologies and services that have been used in Phase I through IV trials, patient registries, diagnostic, and epidemiological studies. For more information, visit lifetree-tech.com. Brad Gallien. Director, Life Sciences Industry Strategy, Oracle Corp., Redwood Shores, Calif.; Oracle Life Sciences delivers a powerful combination of technology and comprehensive, pre-integrated business applications, including key functionality built specifically for pharmaceutical, biotech, and medical-device enterprises. For more information, visit oracle.com/industries/life_sciences. Adrian Hsing. Director, Clinical Data Management, Gilead Sciences Inc., Foster City, Calif.; Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. For more information, visit gilead.com. Greg Johnson. VP, Global Data Management, PRA International, Reston, Va.; PRA International is one of the world’s leading global clinical development organizations, with more than 2,500 employees working from 23 offices. For more information, visit prainternational.com. James Langford. President, DataLabs, Irvine, Calif.; DataLabs is a provider of Internet-based applications for clinical development that help the biopharmaceutical industry accelerate clinical trials with proven software for study design, data capture, and data management. For more information, visit datalabs.com. Judy Sromovsky. Senior Director, Data Management and Clinical Systems, The Medicines Company, Parsippany, N.J.; The Medicines Company meets the demands of the world’s most advanced medical practitioners by developing products that improve acute hospital care. For more information, visit themedicinescompany.com.

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