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DRUG DEVELOPMENT EDC 2001: a (pharma) space odyssey As the pharmaceutical industry moves towards the merging of old economy stability with new economy innovation, technology can finally be expected to make its mark on the drug development process. Brian Chadwick and Scott Grisanti, eResearchTechnology Inc eBusiness and eCommerce can represent both creative and destructive forces - and they have the potential to change just about everything we do 92 A ccording to R&D Directions, pharmaceutical companies have been slow to adopt automation technologies (1). It is estimated that the pharmaceutical industry spends 4-6% of company sales on information technology; this pales in comparison with the 8-10% that companies in other information-intensive industries spend. The perspective that the pharmaceutical industry should or must improve the overall drug development process - because it takes too long and is too expensive - is shared by most industry executives. But what form should these improvements take? Are they strategic or tactical? Should the focus be on technology or process? Should the technology involve one-off solutions that bring incremental value, or should companies aim for the "Holy Grail" - the "end-to-end" solution? But what end and to what end? And where in the new drug development chain should pharmaceutical companies start to experiment with innovative solutions - and when? As easy as some observers believe it is to answer these questions, it is easier still to underestimate how difficult it is to change the way that the pharmaceutical industry has always done business it may well take a lot more time and effort than people realise. Regardless of such opinions, it appears that change - while moving slowly - is upon us. There is an increasing interest by virtually every company involved in the drug development process in technology solutions and the Internet. There is also a growing awareness and acknowledgment amongst industry executives, as well as "grass roots" Innovations in Pharmaceutical Technology DRUG DEVELOPMENT clinical research professionals, that technology innovation can make a positive difference to the drug development process. Andersen Consulting recently reported the results of a survey of 50 R&D executives from large pharmaceutical companies (2). More than half of the respondents agreed that new technologies were fundamentally changing R&D processes; 86% thought these technologies would have a great impact in the near future, and 56% indicated that there was already a high level of urgency within their organisations to adopt new technologies. The Association of Clinical Research Professionals (ACRP) is one of the largest organisations of clinical research personnel with around 15,000 members. In a recent annual survey - conducted in Summer 2000 and involving 2,300 respondents (3) - 66% of sites, 60% of clinical research organisations (CROs) and approximately 50% of sponsors expected to adopt electronic CRFs within the next two years. While current use of remote data entry (electronic data capture, EDC) systems is still rather modest, a much greater acceptance of EDC is anticipated. Nearly half of respondents expected to gather and disseminate clinical data over the Web within the next two years. The association commented: "When ACRP reviews data from its members indicating that sites project more than a 200% increase in Internet use for patient recruitment in a two-year time-frame, and CROs expect a four-fold increase in the use of electronic data capture in this same time period, the Association must conclude that rapid change is afoot." In an address to the Executive Club of Chicago in September 2000, Miles D White, CEO of Abbott Laboratories stated: "Yes, the Internet is among the most powerful transformational forces we've seen in business. Yes, many traditional companies have awakened relatively late to the potential and the demands of eBusiness. And, yes, significant barriers remain before eBusiness becomes a truly integral part of the way most established companies plan and run their operations. But where the prevailing wisdom got it wrong is to suggest that the innovators of these new technologies - the dot-coms and the eCommerce first movers - would be the only companies to thrive in this new economy". As we emerge from the dot-com phenomenon, and as the "technology revolution" of the late nineties becomes the "technology evolution" of the new millennium, the potential of "old-line" companies - including the major pharmaceutical companies - is re-emerging due to some basic "old economy" advantages. Their business models have been tested over time; their customer relationships are strong and they have reliable revenue streams, proven credibility and tested brand names. While Innovations in Pharmaceutical Technology the pharmaceutical industry may indeed be slower than some to adopt technology innovation, maybe in the longer term this conservative approach will prove a winning strategy. Change - the technology lessons learned Since clinical development is the most costly and critical factor in maintaining the pharmaceutical industry's premiere position as regards total shareholder return, it would also seem to be the most likely target for technology innovation - but, to date, this has not been the case. eBusiness technologies are currently being used to transform the buy and sell side of the drug development supply chain. eBusiness and eCommerce can represent both creative and destructive forces - and they have the potential to change just about everything we do. They change established relationships between buyers and sellers; they confound traditional pricing models and they alter established supply chain processes. Miles D White has suggested that in order to be a part of the emerging business model - namely, the reconstruction process that is the synthesis between old economy business and new economy innovation - "companies must be willing to be a part of the deconstruction process as well". Change certainly seems to be upon us. The pharmaceutical industry will evaluate technology innovation to improve operational efficiencies, increase the speed and effectiveness of R&D activities, and enhance the total experience and relationship that customers have with suppliers. And pharmaceutical companies can be expected to learn from the "buy and sell" experience, to continue to observe the ongoing dot-com phenomenon and to scrutinise early forays into electronic solutions for drug development. This change - and the opportunity that surrounds it - therefore comes with a lot of yellow caution flags. It is incumbent upon the change agents in the industry - the technology solution providers and the contract service vendors - to approach this change with care. They should introduce such change into those areas where it is most likely to produce benefit, and deploy user-friendly and cost-sensitive technology applications that bring clear value. There is ... a growing awareness and acknowledgment amongst industry executives, as well as "grass roots" clinical research professionals, that technology innovation can make a positive difference to the drug development process The impact of new technology To measure value, it is critical for pharmaceutical companies to define the practical, probable and possible changes that technology will bring to the drug development process. Until now, there has been little success in managing expectations of the likely impact of technology on drug development. It is important to start with small doses; however, in light of the careful and conservative approach 93 DRUG DEVELOPMENT While the pharmaceutical industry may indeed be slower than some to adopt technology innovation, maybe in the longer term this conservative approach will prove a winning strategy that will no doubt persist, the pharmaceutical industry must resist the perpetual piloting syndrome that has been evident in recent years. The industry must find a balance between the staunch technology conservatism of the past, and the opportunities presented by the "new economy". If expectations are realisable and the perspective is evolutionary - not revolutionary then there is great opportunity to succeed. Points of difficulty and the metrics for success must be identified. When piloting technology applications, the likelihood for success should be good in order to create positive momentum. The objective of the pilot needs to be changed from the "stress test" to the "best test" for effective evaluation; there needs to be a commitment to use technology - rather than an effort to prove that the technology doesn't work. There must be an appreciation of the learning curve - there is virtually no technology solution that can be deployed without some degree of patience and pain! Parts of the process need to change before the entire process can change. There needs to be a plan that reflects the reality of evolutionary change - incremental value first and integrated solutions to follow. Maybe then, the pharmaceutical industry will be in a position to implement end-to-end solutions. Drug discovery groups at large are dabbling with some very innovative technology. High throughput screening (HTS), combinatorial chemistry, computer modelling and simulation, and transgenic animal models are examples of advanced technology solutions that are bringing incremental value to the discovery and non-clinical phases of drug development. Marketing groups are experimenting with and gaining positive advantage from using the Web to create '"communities of interest" around therapeutic categories or specific products. The electronic regulatory submission (ERS) is rapidly becoming the preferred method of application to the FDA. In the clinical phases of drug development, there are examples of successful patient recruitment efforts through the Internet. Safety reporting and trials management applications are gradually finding their way into the process. Collaborative workspace services have received attention recently for idea collaboration and secure document distribution. Online investigators' meetings (synchronised learning) and self-paced learning (asynchronous learning) are finding their place (especially in light of 21 CFR). But what about electronic data capture (EDC)? Electronic Data Capture Electronic data capture is an intriguing subject. It is the year 2001 and EDC has already travelled the path of a 15-year odyssey. Intuitively, EDC has always made sense - but, practically, it is used in 94 only a small percentage of clinical trials. There are a number of reasons for this. EDC is a complex technology, there are workflow issues, and there has been no compelling solution to date that effectively links EDC into the enterprise clinical trials environment. But it is clear that collecting and cleaning clinical trial data through paper-based methodologies is an area of considerable pain and substantial inefficiency. Clinical trials are the most expensive and the most critical area of the drug development process. If there is to be significant improvement in the speed and capacity of drug development, then it must happen in the trial phase. EDC may well have been ahead of its time. Even though, 15 years ago or so, it may have seemed that the trial phase was the right place to introduce technology, with hindsight, it may not have been the most appropriate place to start. Maybe EDC was too revolutionary and not evolutionary enough. We need to draw a deep breath after spending so much time trying to shoehorn EDC into a paradigm that has so far resisted it. It might just be that today, as just one part of an evolving technology paradigm, EDC will be a better fit. But to be that "better fit", EDC applications must address the "mixed-mode" reality - in any clinical trial there are bound to be sites that for one reason or another will not be able to use the technology. EDC solutions must also support paper-based data entry. The evolution of computing has moved from the mainframe era (which was vendor driven), to the client server era (which was technology driven), to the Internet/information era which is upon us now and is clearly user (customer) driven. It is not about technology or process - it is not even about technology and process. It is about people, and how technology and process will better serve them to enhance their ability to do things. EDC has demonstrated incremental value. In a recent article (4), this incremental value was referred to as a "glimmer of hope", where in some cases EDC facilitated the "freezing" or "locking" of a clinical trial database within days after the last patient's last visit. This is in sharp contrast to the 3, 6 or even 18 months it can take when data collection and data correction processes are paper-based. Still, EDC technology has yet to achieve widespread acceptance. In the light of current experience with other incremental technology applications, maybe as EDC is reintroduced into the process as one part of a more comprehensive technology solution, then it will be better received. This may prove especially true for EDC applications that support a variety of data entry methodologies such as online, off-line, paper-based double key, optical and intelligent character recognition (OCR and ICR), as well as Innovations in Pharmaceutical Technology DRUG DEVELOPMENT multiple discrepancy resolution processes. Maybe EDC is starting to make sense to more people. The combination of multiple incremental applications may well become the solution, where the value proposition better addresses the various needs of the different constituents. 3. The Monitor, ACRP White Paper on the Future - Where we are and where we're going. Summer 2000, Volume 14, Issue 2, 17-32. 4. Pharmaceutical Visions. To "e" or not to "e", Spring 1999, 12-16. Conclusion Suddenly, as the dust settles, there is available the clinical trial Website; it has a digital dashboard interface to facilitate ad hoc reporting. There exists the opportunity to choose - in an à la carte fashion - integrated functions and features such as: • news and views, • online investigator recruitment, • synchronous (and archived) investigators' meetings, • secure, rapid document exchange, • Internet-based patient recruitment, • Web-based training, • safety reporting, • trials management, • clinical data entry, and • remote data management. Whether the perspective is incremental value, integrated applications and/or the "Holy Grail" of the end-to-end solution, change is upon us. Within the next couple of years, as the pharmaceutical industry moves towards the merging of old economy stability with new economy innovation, we can expect technology to finally make its mark on the drug development process. References 1. R&D Directions, eDevelopment and the Power of the Internet, November/December 2000, 52-58. 2. Andersen Consulting, R&D and the Internet: Opportunities to Profit from Web-Enabled Pharmaceutical Research & Development, AC10002480, 2000. Innovations in Pharmaceutical Technology Brian Chadwick is a founding partner of eP2, a consulting group focusing primarily on technology and process solutions for clinical trials and drug development. He is also a co-founder of a Web-based training company called the ePharmaLearning Project and is Technology Chair at the ACRP. Before eP2, he was founder and CEO of TechniLogix (an electronic data capture company), a co-founder and general manager of Health & Sciences Research Inc, HSRI (a mid-sized CRO), a CRA at Squibb, and a clinical trials manager at the Albert Einstein College of Medicine, where he also served on the IRB for three years. Mr Chadwick serves on the advisory boards of a CRO and an OSHA Compliance Company, is often a speaker at professional meetings and has 36 publications covering both the science and business of clinical research and technology solutions for the drug development process. The evolution of computing has moved from the mainframe era (which was vendor driven), to the client server era (which was technology driven), to the Internet/information era which is upon us now and is clearly user (customer) driven Scott Grisanti is Senior Vice President of Business Development at eRT where he is responsible for managing the company's field sales organisation with a focus on increasing synergy between eRT's applications and diagnostics technology sales teams in the US and abroad; he is also responsible for establishing and managing key strategic alliances and global marketing activities. Mr Grisanti joined eRT from ClearCross Inc, a leading provider of global commerce management solutions, where he served as Area Vice-President of Sales and was responsible for launch of the company's initial e-commerce products and services. Prior to this, he was Director of Sales for the supply chain execution application provider, Metasys Inc, with responsibility for sales and marketing efforts targeting the contract logistics services marketplace. Before joining Metasys, he served as Director of Workflow and COLD Business Development for Axis-One Inc, where he also served as a Director in the channel sales organisation. Earlier, Mr Grisanti was Director of UNIX Product Marketing for Information Builder Inc - providers of the FOCUS 4GL and EDA/SQL middleware. 95