More than Filling in the Blanks: Knowledge Management and the Pharmaceutical Protocol
Coker, Linda Sue
The scope of documenting processes and data in the pharmaceutical industry is extensive, but documents called "protocols" help guide information for scientists, reviewers of documents in regulatory agencies, and business people. My thesis explores how pharmaceutical protocols, as technical documents, help "manage knowledge" to further scientific studies and manufacture a product that is both safe and effective for public use. "Knowledge management" is an abstract idea that h!).s become an essential part of and should become an explicit approach and strategy of contemporary managers. Technical writers, too, should have this approach and strategy. Knowledge management blends perspectives of technology, organizations, and people into discussions about the conversion of tacit (implied) knowledge to explicit (expressed) knowledge, and the types of technology that can control explicit ~owl edge for competitive gain. Groups, such as managers, subject matter experts (SMEs) and technical writers, who are educated about knowledge management and can understand and practice knowledge management theories, can ensure that pharmaceutical protocols for needed drugs are written as accurately, effectively, and efficiently as possible. Pharmaceutical protocols are far more than documents with blanks that need to be filled in; they help convey some of the information that is needed to get a drug approved by regulatory agencies such as the Food and Drug Administration (FDA). The pharmaceutical industry uses protocols extensively, but little research is available on how these protocols manage information. An inquiry into the history of the pharmaceutical protocol and the rhetorical situation of the protocol helps demonstrate the relationship between the data in the protocol and manufacturing, regulatory, and business interests. For confidentiality purposes, I created a composite company called "LC Pharmaceuticals," and used the pseudonyms of "Benjamin Johnson" and "David Williams" for names of two experienced scientists I interviewed to describe activities of gathering data and describing procedures performed by technical writers and SMEs. The pharmaceutical manufacturing protocol is used as a model for discussion. Several knowledge management theories relate to pharmaceutical protocols. The first is that of "mental models," also known as schema or patterns, which are organizational principles (beliefs) that include "error treatment" (how writers treat each other's errors) and the presence of a "sharing culture" (how they share information.) Creating a successful organizational structure helps produce successful subsequent documents that help technical writers and SMEs collect specific information for the dossier. The second theory of knowledge management is the "seed" document model, a structure initially designed for the preparation of a filing or "dossier" for submission to a regulatory agency, but which can also be used on a smaller-scale framework such as a pharmaceutical protocol. Other theories include discussions about tacit or implied knowledge and explicit or fully expressed knowledge, and conversion of tacit knowledge to explicit knowledge. Another theory is the development of documents as "artifacts" and how the management of tacit knowledge also can be seen as the tacit management of managing knowledge, suggesting that the content of the tasks should include the description of the various tasks and the identification of who owns or is responsible for performing the tasks. A final theory addresses the writing of documents for regulatory requirements. Controlling and managing knowledge in documents created during the drug development process is critical, because the documents communicate information that is scrutinized by government regulatory agencies such as the FDA. A limited number of examples of protocols are available because of the confidential nature of pharmaceutical research and manufacturing processes. For this reason, studying the conversion of tacit knowledge to explicit knowledge can be cumbersome since examples are rare. Therefore, the composite LC Pharmaceuticals and my communication with Johnson and Williams further guided my explorations of knowledge management and the pharmaceutical protocol. The impact of knowledge management theory on the pharmaceutical protocol is affected by the impact of technological innovations, such as "eXtensible Markup Language" (XML) web-based applications, on pharmaceutical protocols. Application of principles of usability research, combined with knowledge management theories, focuses on the user to create a "friendly" interface that helps ensure that the output of the technical writer is executed accurately and efficiently. Research for this thesis used qualitative methodology to answer several questions. The first question reviews the history and rhetorical situation of the protocol in the pharmaceutical industry, in addition to what happens when the protocol addresses issues other than scientific issues, such as regulatory requirements. The second question asks why the form of the protocol is so important to its users. Another question examines the purpose of the protocol as a requirement other than the documentation of science, addressing the business issues as well. A final question addresses the need for the protocol in the pharmaceutical industry. The qualitative, rather than quantitative, methodology of using a literature survey, creating an ethnographic study with LC Pharmaceuticals as a composite company, and conducting an interview with skilled scientists created the approach needed to use knowledge management theories for analysis of pharmaceutical protocols. Further inquiry into the relationship of the protocol and knowledge management theory presents several more topics of research. For example, analysis is needed on the relationship of knowledge management theory and the pharmaceutical protocol on an international and/or global perspective. Additional investigation is needed on regulatory issues and knowledge management theories in pharmaceutical protocols. Also, examination is needed on the political nature of a pharmaceutical protocol and knowledge management theory. Finally, another topic of research is the effect of knowledge management theory on project management in the pharmaceutical industry.
knowledge management, pharmaceutical technology, pharmaceutical industry, standards
Coker, L. S. (2005). More than filling in the blanks: Knowledge management and the pharmaceutical protocol (Unpublished thesis). Texas State University-San Marcos, San Marcos, Texas.