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Improving and Monitoring Clinical Data Management

Improving and Monitoring Clinical Data Management in the eClinical Age

a report by

James Streeter

Executive Director, Electronic Data Capture, PPD, Inc.

As the pharmaceutical industry moves into the eClinical age, much is changing and more change is possible. Technologies such as electronic data capture (EDC) have enabled clinical studies to become larger and more complex. Furthermore, they have supported the global expansion of trials, particularly to patients in developing countries. However, the introduction of EDC has also put more pressure on companies to increase the scope of their trials, all while containing costs. PPD is a large global contract research organization (CRO) working within the trends of globalization and more complex eClinical trials. The company's large global presence means that clients can take advantage of its economies of scale, while the web-based nature

Business Goals EDC has been a major enabling technology, allowing companies to extend their business goals beyond what was possible with paper systems. The web-based Oracle RDC 4.5.3 gives companies a larger global reach to monitor and manage data across the world. Processes such as collating all global data used to take four to six weeks, but can now be performed in one to two weeks. Database lock time has been reduced to 10 days (100­400% less time than when using paper). However, while eClinical technologies have allowed the pharmaceutical industry to make leaps forward in clinical trial management, they have also increased the pressure to run faster trials that enroll even more patients. This puts pressure on trials to become more global, particularly as it becomes more difficult to find treatment-naïve patients closer to home. In addition, the cost of drug development is rising, but the pressure remains on pharmaceutical and biotechnology companies

At the start of 2009, PPD is seeing 50% of its trials undertaken in an electronic format. Within the next few years, we predict that electronic trials will overtake paper-based trials.

to contain costs. In the face of these changing times, CROs can help ease the pressure for their clients. A client can take advantage of the experience and economies of scale of a large CRO, such as PPD. Global CROs have more contacts and investigators in various countries worldwide, including in the developing world, and they can generate efficiencies in terms of data management.

of its primary platform--Oracle Remote Data Capture (RDC)--allows easier access to trial data in a real-time fashion for safety and monitoring purposes. Furthermore, PPD has worked as a beta tester for Oracle's latest offering, Oracle RDC 4.5.3, focusing on leveraging the technology for investigator use and improving its data management functionality. Changing Face of Clinical Trials Clinical trials are becoming larger and more complex but can be carried out more quickly than ever before, all thanks to the adoption of eClinical technologies. At the start of 2009, PPD is seeing 50% of its trials undertaken in an electronic format. Within the next few years, it is predicted that electronic trials will overtake paper-based trials, but there will still be a need for paper trials for some specific trial types and sizes. EDC platforms such as Oracle RDC allow investigators to monitor trials more easily and to access and analyze vital data on a regular basis. Such platforms also allow regulatory bodies and data safety monitoring boards (DSMBs) easy access to trial data. Easier access means that agencies such as the US Food and Drug Administration (FDA) will be able to play a more participatory role in the setup and running of trials to ensure that quality and standards are maintained in this new wave of eClinical technology.

Globalization Clinical trials are increasingly pushing out into new global locations, and the spread has been particularly rapid in developing countries. This means that CROs need to be global too (see Figure 1). PPD has been running studies spanning the globe, with offices in 33 countries worldwide. As well as multiple offices in North America and Europe, the company has a large number of bases in Latin America and Asia, an office in South Africa, and one in Israel. PPD is continuing to expand its presence, anticipating a rise in trial volume in these regions.

James Streeter is Executive Director of Electronic Data Capture (EDC) at PPD, Inc, a position he has held since 2006. He applies his extensive experience in EDC, data acquisition, data management, and analysis, working directly with clients to incorporate EDC into their development programs. As the leader of PPD's global EDC core team, he provides project teams with the technical process and training support services necessary to ensure proper deployment and execution during the critical start-up, monitoring, and close-out phases of clinical studies employing EDC. Mr Streeter gained much of his EDC experience at Pfizer as Senior Director of Global Clinical Data Services, heading the Global Data Acquisition Department for the company's global research and development organization. Prior to joining Pfizer, he was a senior hardware, software, and systems engineer for the US Navy Underwater Sound Laboratory, with a focus on data acquisition and analysis.

© TOUCH BRIEFINGS 2009

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Improving and Monitoring Clinical Data Management

Figure 1: Globalization of Clinical Trials and of PPD

Canada

US (26)

Belgium (2) UK (4) France Germany Italy The Netherlands

Sweden Denmark Poland Czech Republic Hungary Greece Turkey Spain Portugal Israel India (2) Korea China (2)

Taiwan

Mexico Number of clinical trials Canada = 4,768 US = 33,369 Mexico = 774 Carribean = 1,010 South America = 1,576 Europe = 13,080 Africa = 1,362 Middle East = 1,952 Russia = 947 East Asia = 838 China = 3,249 Australasia = 1,882 Japan = 907 South-East Asia = 901

Source: www.clinicaltrials.gov, July 2008.

Thailand Singapore

Peru Brazil Chile South Africa

Australia

0­1,000 1,000­2,000

2,000­10,000 10,000­20,000

20,000­40,000 PPD global offices

With a totally web-based platform such as Oracle RDC 4.5.3, these disparate locations can communicate effectively. Employees can log in from various locations both on- and off-site to manage, monitor, and analyze data. The platform has a footprint of zero--it needs no installation at the actual trial site--thus avoiding many potential setup issues. Full training for the system can be achieved in 45 minutes to an hour, and if a site already has experience using another EDC program, the process is even easier.

high-speed Internet links and other forms of access. Countries are generally willing to adapt to eClinical demands quickly, with investigators keen on using new technology platforms that can boost their clinical trial parameters. Particularly poor areas, such as some regions in Africa, completely lack basic communications infrastructure such as telephone lines, and are likely to do so for some time to come, but they have already made the leap to using cellular phones based on wireless networks. New eClinical technologies that can run using wireless communication networks or satellite links are emerging, effectively bypassing the need for a classic IT infrastructure.

Electronic data capture platforms need to be user-friendly to give an investigator confidence in using the system and to increase the efficiency and trial workflow rather than slow it down.

Enhancing the Investigator Experience The importance of the investigator in implementing eClinical trials has long been overlooked, but now enhancing the investigator eClinical experience is becoming a key part of leveraging such technologies. EDC platforms need to be user-friendly to give an investigator confidence in using the system and to increase the efficiency and trial workflow rather than slow it down. Finding clinical investigators is very competitive and CROs are having to work harder to retain them. New Research Areas As companies push further into these new regions, it is important to remember that many sites will be new to clinical research. In such cases, implementing eClinical technology can prove challenging. Moreover, relationship building and proper training is needed to promote investigator confidence in using these platforms. Getting clinical sites up and running can be especially problematic in developing countries that lack the standard IT infrastructure. However, technology challenges in these areas are starting to improve. Technology is spreading rapidly and many of these regions are gaining There is also demand for an eClinical tool that allows investigators to handle larger volumes of complex data more easily. With Oracle RDC 4.5.3, case report forms (CRFs) are easy to navigate and provide search and sort functions and a robust system of edit checks to ensure data accuracy. There is a combined interface for discrepancy management and the CRF itself on one screen, so that users can scroll through and work on discrepancies without having to add pop-up windows or use different tools. In addition, investigators can interact with monitors and data management teams in a more real-time fashion, which means that they are able to close queries within days--something that could take one to two months with paper-based systems.

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ECLINICAL VISIONS

Improving and Monitoring Clinical Data Management in the eClinical Age

Of course, the platform also literally reduces the volume of paper used, so investigators no longer have to find storage for bulky casebooks. All clinical data can be stored on a CD. An Agent of Change PPD has worked closely with eClinical providers such as Oracle specifically on Oracle RDC, as well as its business intelligence, safety packages, and clinical trial management system (CTMS). As part of its strategic development partner (SDP) program, PPD has acted as a

biotechnology, medical device, and other CRO companies and offers consulting services for clinical trial and drug safety applications. CSS Informatics can host all types of eClinical EDC system for clients and provide training on their use. As a result, PPD has experience using a variety of eClinical systems on the market, performing approximately 125 studies using Oracle Clinical RDC and 80 studies using third-party EDC platforms. The combination of PPD and CSS Informatics' service offerings creates a broad, integrated service for clients. Along with Oracle's RDC platforms, PPD also has an in-house EDC

Understanding the investigator's technology needs improves the investigator's relationship with eClinical systems and its relationship with the contract research organization.

system. While Oracle's RDC is more geared toward phase I­III trials, which are more standardized in their trial management processes, PPD's proprietary EDC platform--GlobalView--is used for postmarketing and medical device trials, as it allows for more dynamic control of these extended and highly variable studies. As GlobalView has a programming ability, PPD can integrate its system with Oracle RDC to share data across both systems. Future Perspectives With each phase of eClinical development, technologies are increasingly able to cope with larger, more complex trials, a trend

customer advisor and worked as a beta tester on a pre-release version of RDC 4.5.3. PPD's investigator focus made it able to provide feedback to Oracle on various issues and act as a voice for its various investigator sites. PPD's participation has helped increase investigator site performance, simplify the user interface, eliminate software installation issues, and realize a fully web-based system.

that is likely to continue into the future. For CROs, one of the biggest issues will be ensuring adequate training for employees and investigators using these systems. The future direction of all of these systems will be determined by how well we can consolidate them and integrate data. Currently, there are a variety of eClinical systems, including CTMS and

PPD particularly focused on how various eTechnologies would be used in practice by investigators and assessed how the various tools could make the job of the investigator easier. In the first instance, the firm directly questioned investigators, asking what eClinical abilities they would need to optimize their resources. The company also visited various investigator sites as part of its research, getting feedback from investigators and testing the systems first-hand to establish which add-on elements would improve the platform and help trial management run more smoothly. By focusing attention on investigator usage, PPD has become a technology leader in the eClinical field. Understanding the investigator's technology needs improves the investigator's relationship with eClinical systems and its relationship with the CRO. As a result, PPD is better able to retain investigators in wide-ranging global locations, making it a more attractive proposition for potential clients. It is not just investigators that have to cope with the switch to eTechnologies; CROs must adapt too. Employing eClinical platforms means huge changes for the day-to-day workflow of monitors and project management staff. PPD has implemented comprehensive training programs and hired employees experienced in using such platforms. Once employees have sufficient training and are exposed to eClinical studies, they start to feel the benefits to their workflow, finding they can work faster and more efficiently, managing data and responding to queries in real time. Technology Integration Unusually for a CRO, PPD also has its own informatics division-- CSS Informatics--which provides software for pharmaceutical,

safety and database management systems, that tend to work separately. In the future, companies are looking to combine and integrate these systems using data warehouses and business intelligence, ending the need to sort data manually. In addition, webbased platforms will make it far simpler for systems to communicate with each other. Eventually, technology will progress to where firms only need to set up one central system to control all variables within the eClinical paradigm. A single massive coordinated system would have a single

With each phase of eClinical development, technologies are increasingly able to cope with larger, more complex trials.

login for users to view all aspects of the trial in real time at any time. Clinical trials using such a system would create cost and time savings, allowing CROs to run their studies more efficiently and to collect higher-quality data. The end result would be a more integrated approach to eClinical technologies and faster, larger, and less costly clinical trials.

ECLINICAL VISIONS

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