The E-Arena June 2006 VIEW on Clinical Services Practice Makes Perfect — E-Clinical Trial Standardization John Cline, CEO By having data in set formats, identifying trends and reporting key pieces of information across multiple trials will be possible. And that’s key to drug and device review and the FDA’s approval process. The art of “standardizing” operational processes to take full advantage of e-clinical technology is still in its infancy. But more and more companies are now reaping the benefits of standardization across clinical-trial research through the use of form and report libraries, consistent training practices, and repeatable tool development and implementation. These tools are enabling companies to conduct comparative analysis across both archived and active studies as well as to streamline the development timetable. Many pharmaceutical, biotechnology, and contract research organizations have searched for a system that will streamline their clinical trials to reduce the high personnel costs of collecting and entering data from paper, decrease the time to clean and lock the database, and increase the timeliness of managing patient safety. By using a library of standard cross-study eCRF (electronic case report form) modules, standard edit checks, and standard naming conventions for data points, companies can simplify and streamline their entire clinical-trial management process. Most importantly, this standardization is making it possible to go from trial implementation to live eCRF database deployment much faster allowing for quicker clinical drug development. Establishing Standards In the typical design phase of an e-clinical trial the sponsor’s CRF developers work closely with the vendor’s clinical operations team to build the electronic equivalents of the CRFs. The team builds eCRF pages (or panels), programs edit checks, and prepares the study database. Finally, there is a series of iterative steps to test and review the methods for study data collection before actual deployment, ensuring the system is fully validated before the first volunteer receives the first dosage. One method for simplifying and streamlining the entire e-clinical process is to establish companywide standards for clinical data. For example, a company can develop a library of reusable electronic CRFs, and edit-check criteria and naming conventions for data points that enable the clinical team, in many cases, to halve the time spent on the data capture aspect of trial development and deployment time. This can also result in a 50% cost savings compared with typical eCRF trial deployment with no prior standardization. By leveraging a fully computerized process, a sponsor or CRO can submit study protocols,and sample CRFs, edit-check functionality requirements and suggested panels to be designed for the eCRF. This documentation enables a development team to assist in eCRF design and facilitate its implementation. The development team can then access a library of standard electronic modules, variable names, etc., to speed the development process and bring studies live more quickly. This library of standard modules and edit checks is constantly updated as new trial criteria are presented, further streamlining the development of the next trial’s eCRFs. Storing standardized visits or pages in a logical library system facilitates retrieval and rapid development. Streamlining the Process The trial-development process typically involves many different people, in different therapeutic areas, and incorporates a wide array of CRF designs, edit-check criteria, and data-point names. This, coupled with traditionally used paper-based CRFs that require double-data entry and significant data cleaning, including multiple paper-based queries, makes immediate access to data impossible and lengthens the entire process, resulting in higher costs. By using an accepted process that is implemented across all trials being conducted, each trial benefits from this library of specific standards. For example, this method allows for an industry leading ability to assess and report data from across several trials. As a result, trends may be studied more quickly and accurately. Safety monitoring is further enhanced by the real-time transmission, review, and assessment of important patient data, such as adverse events and clinically significant abnormal vital sign measurements. The company is able to quickly and accurately gauge any potential safety issues that could occur with a new compound. This approach to study design is also important in planning for future standards. By maintaining set parameters for its own internal data, the company’s transition to whatever standards the industry demands, such as CDISC, and integrating databases for submission can be nearly seamless. The turmoil the industry has seen regarding safety issues will further encourage the use of such data standards. By having data in set formats, identifying trends and reporting key pieces of information across multiple trials will be possible. And that’s a key component to drug and device review and the FDA’s approval process. Overall, the necessity of using standards is apparent in all aspects of the clinical-trial process. By leveraging set standards in the data collection and analysis process, e-clinical technologies will continue to make it possible for sponsors to bring new compounds to the market quicker, safer, and more efficiently. etrials Worldwide Inc., Morrisville, N.C., is an eClinical software and services company offering pharmaceutical, biotechnology, and CROs worldwide a suite of technology-based tools, including electronic data capture, electronic patient diaries, interactive voice response, and clinical-trial management. For more information, visit etrials.com.

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