The End of the Paper Chase

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Responses to an ongoing survey and face to face discussions with executives from pharmaceutical and biotech companies reveal their greatest concerns and hopes as they begin to streamline the clinicaltrials process.

IN AN EXCLUSIVE WITH PHARMAVOICE, ELLEN SEMPLE,VP, MARKETING, CB TECHNOLOGIES INC.EXPLAINS WHY YESTERDAY’S ARGUMENTS FOR PAPER PROCESSES NO LONGER RING TRUE

While the majority of companies are still using paper in some capacity in the clinical trial data collection process, success and growing confidence in EDC systems are driving adoption. The END of the It’s no secret that research is the foundation on which sound business decisions are made. As is the case with all productrelated markets, there is no better plat form for success than understanding needs, usage trends and behaviors, and adoption drivers in technologyrelated products. For anyone not familiar with electronic data capture (EDC) software, this application harnesses the power of technology and the Web to streamline clinicaltrial processes for pharmaceutical, biotech, contract research organizations (CROs), and medicaldevice companies. EDC technology helps those involved in clinical trials to electronically collect, organize, and send clinicaltrial data from investigators sites to a central database. Although industry estimates indicate that nearly 95% of tri als currently are conducted using paperbased processes, the majority of leading pharmaceutical organizations are, at minimum, piloting EDC in clinical trials. Industry analysts such as Silico Research, Forrester, Gartner, and Frost & Sullivan report that some industry innovators plan to go 100% electronic within the next few years. According to Ellen Semple, VP marketing at CB Technologies Inc., an independent research report commissioned by the company found that the emerging EDC market (currently estimated at about $60 million) is expected to soar to $1.3 billion by 2010, with adoption potentially esti mated at 50% by 2005 (more than 10 times what it is today). But the road to “2005” will be traveled only by proven EDC solu tions that demonstrate value to sponsors and users. Specifically industry Ellen Semple insiders agree that EDC providers will need to address the demands of both clinicaltrial sponsors and the technology users. “The winning solutions will increase the efficiency of trials, integrate flawlessly with existing technology investments, and employ technologies that are secure and user friendly,” Ms. Semple says. ACLOSER LOOK Behind each of these EDC man dates there is a need to increase effi ciency in clinical trials and time and money. “These are critical enemies of successfully bringing drugs to mar ket,” Ms. Semple says. “Any delay in a clinical trial can equate to loss of `first mover advantage,’ which generally correlates directly with higher volume and revenue poten tial. Also, as a compound painstak ingly progresses through the vari ous phases toward approval, its cost of failure rises substantially.” Ms. Semple says the sheer vol ume of trials is overwhelming. According to Accenture’s report “Speed to Value,” the industry’s goal is to triple new chemical entities by 2008. With persistent performance and profitability pressures bearing down on pharmaceutical organiza tions, it is crucial to increase the number of drugs produced and suc cessfully marketed. “Time to market is not just an internal process, reengineering and per formance are big issues for pharma,” she says. “With the escalating number of patients per trial, pipeline growth, and NDA filings, trial capacity has not kept up. According to PhRMA, due to sheer volume and heightened scrutiny (the FDA places roughly 9% of submissions on hold due to safety concerns), the FDA is taking more time to approve fewer drugs. In fact, the FDA approved 27 new drugs in 2000 compared with 35 in 1999 and 30 in 1998. In addition, the average approval time for these drugs was 17.6 months in 2000 versus 12.6 months in 1999 and 11.7 months in 1998.” ENTRENCHED PROCESSES According to Ms. Semple, the industry is ripe for process improve ment via effective use of information technology ranging from trial recruitment and EDC, to data ware housing, data mining, and Web enabled research. “An overwhelming amount of timeconsuming, paperladen (yet trusted) processes are entrenched in pharmaceutical drug development and commercialization,” she says. “Because of this, process reengineer ing is top of mind with executives of many of today’s leading global pharma organizations.” What’s holding back a more streamlined approach to clinical tri als? “This situation is very similar to a cumbersome, paperdriven environment that drove the finan cial services sector less than a decade ago,” she says. “However the finan cial services sector has emerged to become what many consider a best practice case study in harnessing technology. Efficiencies gained through use of technology in the this sector are now widespread — funds are wired internationally and instantaneously every minute of every day. A truly global market has arisen thanks to highly secure net works. And financial services giants demonstrate the efficiencies and effectiveness of harnessing technolo gy every day.” AMATTEROFTIME Many pharma executives clearly see the need to increase efficiencies in some part of the clinicaltrial process. At a high level, executives are concerned by the need to maxi mize return on research and development investments. On a more gran ular level, Ms. Semple says, executives are concerned with improving data quality, improving query processes, and speeding up backend data processing. Viewing, capturing, and analyzing cleaner data faster are overwhelmingly a critical priority. Ms. Semple cites a F.A.C./Equities report, which states successful companies will use the Internet and related information technologies to streamline the clinicaltrial recruitment process of patients and investi gators; lessen reliance on paper and manual entry in the research process; allow realtime data sharing among sponsor, investigator, and patient; and submit NDAs electronically to the FDA, among other tasks. “Sponsors aren’t alone in wanting streamlined processes,” she says. When it comes to EDC, Forrester’s July 2001 study reports of a sub VIEW on EDC 65 PharmaVOICE M a y / J u n e 2 0 02 Winning EDC solutions will increase the efficiency of trials, integrate flawlessly with existing technology investments, and employ technologies that are secure and user friendly. An overwhelming amount of time consuming,paperladen (yet trusted) processes are entrenched in pharmaceutical drug developmentand commercialization. Because of this, process reengineering is top of mind with executives of many of today’s leading global pharma organizations. The road to “2005”will be traveled only by proven EDC solutions that demonstrate value to sponsors andusers. Specifically industry insiders agree that EDC providers will need to address the demands of both clinicaltrial sponsors and technology users. VIEW on EDC sample of 101 clinical professionals using Webbased EDC found that 61% had a strongtomoderate preference for Webbased EDC. Only 15% of the subset showed a strongtomoderate preference for pen and paperbased trials. USER ACCEPTANCE “The old EDC arguments such as `users just don’t want it!’ seem to be fading,” Ms. Semple says. “While there are, and probably always will be, those involved in the daily conduct of clinical trials who may never embrace technology, undeniable market and productivity pressures inevitably will force abandoning of paper trials for the Web. “It’s important to note that clinicaltrials professionals don’t dislike technology; in fact, they are waiting for the signal from above,” she says. “Generally, data point to the fact that greater inoffice efficiencies, fewer monitor vis its, reduced queries, and related cost savings drive this openness.” The true success of transitioning clinical trial data collection to EDC lies in how well the users embrace the technology. In CB’s sur vey, user acceptance topped the list of concerns in using an EDC system (69% of respondents), and this attitude is reflected again and again by clinical executives. But the secondhighest concern is system performance, and these issues are very closely tied, Ms. Semple says. Executives know that to truly drive user acceptance, the technology must be reliable and work when users need it. System performance drives at the heart of ease of use for the enduser and ultimately impacts how well users embrace a system. In fact, CB’s data indicate that users at the site are concerned principally about how easy it is to enter data and answer queries. “In today’s fastpaced society, we have little patience for things that don’t move along as expected,” Ms. Semple says. “As bandwidth has become more ubiquitous (T1 lines at work, cable modems at home), we have high expectations for the speed of software applica tions. But depending on the architecture of the software used, collecting and transmitting clinical data over the Internet doesn’t always happen with the push of a button. In meetings with clinical executives, a running theme was using EDC technology eventually to help recruit and retain the best investigators. But for this to happen, executives said they look to vendors to provide a technology with excellent performance that prevents excessive down time due to Internet performance. By elimi nating this frustration for the sites, the overall EDC experience greatly improves.” INTEGRATIONWITH EXISTING SYSTEMS Pharmaceutical organizations are commit ted to moving beyond standalone or pilot EDC implementations. Industry leaders are focusing on the tremendous value they see in creating a fully integrated clinical IT environ ment — thus maximizing investments in other technologies. According to Ms. Semple, pharmaceutical executives consistently cite the need to inte grate with various existing investments in backend systems including datamanagement systems such as Oracle. (According to a recent Oracle media release, 65% of lifescience com panies are running Oracle technology.) Other systems investments where executives demand EDC integration include lab data, clinicaltrial management systems, dictionary management systems, and patient diary technologies. According to Ms. Semple, fully integrating these technologies brings a multitude of ben efits, including scalability, speed, quality, security, and improved workflow. “Systems integration for companies can be difficult, timeconsuming, and expensive,” she says. “While no single EDC system will come as an immediate plugin to existing applica tions, it’s clear that sponsors are looking to vendors to provide software that has taken sys tems integration into consideration by having an open architecture.” While the majority of companies are still using paper in some capacity in the clinicaltrial datacollection process, success and growing confidence in EDC systems are driving adop tion. Executives clearly see the benefits, and with the pressures to improve processes and cut development time, they are actively pursuing opportunities to save time and money. Like the example of technology adoption in the financial services industry, success begets success and effi ciencies gained through use of technology will continue to build momentum for applications like EDC. As pharma and biotech industry leaders examine the opportunities that advance organizational efficiency and value, proven, userfriendly EDC technologies will surely be drivers of tomorrow’s medical innovations. F PharmaVoice welcomes comments about this article. Email us at feedback@pharmalinx.com. 66 M a y / J u n e 2 0 0 2 PharmaVOICE Although industry estimates indicate that nearly 95% of trials are currently conducted using paperbased processes, the majority of leading pharmaceutical organizations are,at minimum,piloting EDC in clinical trials. Industry analysts report that some industry innovators plan to go 100% electronic within the next few years. When it comes to EDC,Forrester’s July 2001 study reports of a subsample of 101 clinical professionals using Web based EDC found that 61% had a strong tomoderate preference for Webbased EDC.Only 15% of the subset showed a strongtomoderate preference for pen andpaperbased trials. The emerging EDC market (currently estimated at about $60 million) is expected to soar to $1.3 billion by 2010, with adoption potentially estimated at 50% by 2005 (more than 10 times what it is today in just three years). CB’s survey found user acceptance topped the list of concerns over using an EDC system (60% of respondents) and this attitude is reflected again and again by clinical executives.The secondhigh est concern is system performance. According to PhRMA,due to sheer volume andheightened scrutiny (the FDA places roughly 9% of submissions on hold due to safety concerns), the FDA is taking more time to approve fewer drugs.The average approval time for these drugs was 17.6 months in 2000 versus 12.6 months in 1999,and 11.7 months in 1998. Successful companieswill use the Internet and related information tech nologies to streamline the clinicaltrial recruitment process of patients and investigators; lessen reliance on paper andmanualentry;enable realtime data sharing;and submit NDAselectronically. ELECTRONIC DATA CAPTURE TRENDS AND STATS

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