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Protocol Standards are Statistically Significant: Presenting at a PhUSE Single Day Event on PRM

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I recently attended a PhUSE (Pharmaceutical Users Software Exchange) Single Day Event (SDE) in Northbrook, Illinois, where industry colleagues shared their implementation experiences, what challenges they have faced and what lessons were learned. Presentations included the implementation of the Clinical Data Interchange Standards Consortium (CDISC) standards across the clinical data life cycle. PhUSE has expanded from its roots as a conference for European statistical programmers, to become a global platform for the discussion of topics encompassing the work of data managers, biostatisticians, statistical programmers and eClinical IT professionals. At the SDE, I presented on the implementation and use of the CDISC protocol standard (Protocol Representation Model in the real world!). PhUSE, in general, is well attended by the biostats organizations and those responsible for analysis and submission of study data and results. I always welcome the opportunity to present on study and protocol design to such an audience. The concept of structuring study design early in the clinical study process resonates well within a community of users who are typically technology savvy and understand the benefits of standardized and structured content used early in the study development process. The theme of standardization—and more importantly reuse and sharing of efforts—was common across the set of presenters. Important lessons were learned, experiences were shared and not surprisingly most attendees had common observations of utilizing CDISC and standards within their respective organizations. When I spoke of the concept of creating structured design content—based on standardized and reusable content where applicable—the nodding heads in the audience simply reinforced that at least conceptually, little convincing was needed on the benefits. The challenges come in implementation, changing the way people have worked for literally decades:

  • Study design restricted to processes and capabilities of word processing software such as Microsoft Word.
  • Entire SOP's built upon the constraints of an electronic document of unstructured text.

Although possibly a somewhat argumentative view, I present and challenge the notion that document headings and sections in an electronic document serve as true structured content. With the recent release of the Protocol Representation Model (PRM) standard from CDISC, we have begun to bridge the gap between unstructured, narrative study documents and highly structured study designs. I presented the recent findings from Tufts Center for the Study of Drug Development (CSDD), showing that the use of a structured approach to study design—coupled with data-driven benchmarks of standardized content and design—can yield significant gains across the industry. It can reduce trial complexity, execution (and analysis!) of non-core activities and its resulting data, and ultimately also reduce study costs. It's this type of quantitative value analysis that will provide the financial impetus for the industry to start addressing the earliest stages of the clinical study process. As an industry, we have made significant strides in the implementation of standards and repeatable processes in the analysis and submission stages of the study. Now is the time to start with that end in mind and build a truly end-to-end process from concept to conclusion... from protocol to p-value! Guest blogger David Gemzik is vice president of implementation services at Medidata Solutions. You can reach David by email or follow him on Twitter @gemzik.

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