24 June 20 08 VIEW on Clinical Operations ECLINICAL W hen life sciences companies in the previous millennium tried to figure out how the application of IT could help them save time and money in their clinical development processes, electronic data capture (EDC) and clinical data management (CDM) were the natural places to start. Years later, the use of EDC and CDM in clinical trials has gained mainstream acceptance, and efficiencies are starting to become realized industrywide. However, standardized adoption means that new opportunities for com petitive differentiation must be sought out; trial sponsors are looking at other areas of the clinical trial process to apply eClinical disciplines. One such area that holds promise of significant new gains is clinical pro tocol authoring and study design. Although the scientifically informed, complex nature of protocol author ing does not lend itself to standardized processes — hence, perhaps, the ini tial reluctance to take on the task — it is arguably the most critical and foundational stage of clinical research.The protocol is the central document — in essence the “blueprint” — of a clinical study, that sources the infor mation for all other documents, such as the clinical trial agreement, the CRFs, and study manual, and informs the configuration of every clinical IT system, including IVRS, CTMS, and CDMS. It is the one document that incor porates input from, and is used by all functional groups at the study spon sor : operational, regulatory, scientific, medical, data, and marketing. Because of this central role, any error or ambiguity in, or change to, the protocol can propagate through other documents and systems, with potentially profound consequences. As the complexity of clinical studies continues to grow (~10% CAGR since 2000), so does the financial impact of not planning, set tingup, and executing them as quickly and efficiently as possible. eProtocol is the Key According to a PhRMAsponsored Gartner study, more than half of the value of implementing standardized data and processes occurs during the study startup stage, with times potentially reduced by 70% to 90%. In recognition of these benefits, many pharmaceutical companies are looking for tools to enable structured data creation at the studydesign stage: enter eProtocol. The basic premise behind eProtocol is that the immense amount of work already performed at the study design and protocol development phases can be leveraged throughout the clinical process, rather than being manually copied and reinterpreted throughout the pro cess. It also offers a structured environment, where medical writers can benefit from a comprehensive repository of bestpractices that guide them through the authoring process, ensuring that nothing is missed and enabling sponsors to develop a standardized and repeatable approach to designing clinical studies. Although some sponsors have been slow to invest in eProtocol, the trend has gained momentum among pharmaceutical companies and is poised to become a new standard for the industry. Benefits of eProtocol include eliminating ambiguities and inconsistencies, identifying unnecessary procedures, incorporating real time cost benchmarks to guide the study development team, and reducing manually quality control processes. The Role of EDC The ability of eProtocol simultaneously allows lifesciences researchers to take advantage of efficiencies twice: reuse of protocol authoring elements from previous studies, as well as reuse of study design information by other functions and systems further downstream. By capturing the studydesign information in a structured data model that can be exported using standards based computerbased formats, such as XML and CDISC ODM, that infor mation can be used to populate critical downstream systems. A key example is leveraging eProtocol data to streamline EDC studybuild and set up, includ ing creation of eCRFs and analysis forms within the EDC and CDM system. As each type of system within the clinical trial process, such as EDC and CDM, reaches the limit on gains that can be realized, the search for new appli cations and new ways to tie systems together increases.With eProtocol med ical writers can simultaneously create both the protocol design document and EDC/eCRF, and other system data specifications will once again introduce a leap in productivity and a race to be first to standardize such solutions. # Medidata Solutions MEDIDATA SOLUTIONS is a provider of clinical trial solutions that enable the world’s most advanced life science organizations to maximize the value of their clinical research investments by putting powerful tools into researchers’ hands. For more information, visit mdsol.com. The New Frontier: EDC and eProtocol, the Clinical Process Gets Even Smarter The ability of eProtocol to simultaneously allow medical writers to create both the protocol design document and EDC/eCRF and other system data specifications will once again introduce a leap in productivity and a race to be first to standardize such solutions. Ed Seguine, General Manager,Trial Planning Solutions 0608 pvv layout FINAL 5/29/08 11:44 PM Page 24 Tasmania, Siberia, Timbuktu. The complete solution for anywhere your clinical research takes you. Medidata Rave Works on any computer Through any browser In any language For EDC and CDM And it’s a snap to learn. Technology for a healthy world. TM www.mdsol.com 1.212.918.1847

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