The Future of Medical and Technical Writing
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0092-86 15/99 Copyright 0 1999 Drug Information Association Inc.
THE FUTURE OF MEDICAL AND TECHNICAL WRITING STEPHEN DE
LOOZE,PHD
Head of Medical Writing, Hoechst Marion Roussel, Frankfurt, Germany
The future of medical and technical writing in the changing technological and regulatory environment is discussed, with a focus on the writing of documents f o r clinical trials and regulatory submissions (eg, clinical study protocols and reports, summary-level documents, and dossiers), though similar considerations apply to other medical and technical writing tasks. The aim of medical writing, namely to transmit complex information and key messages to the reader as unobtrusively as possible, results in its invisibility and hence in a lack of awareness of writing skills by the (nonwriting) average reader of clinical and regulatory documents. This, in turn, leads to a misconception that new technologies may be able largely to replace writers by electronic tools that can generate complex documentation automatically, “at the touch of a button.” The role of medical writers in generating text, tables, andfigures, and in designing and assembling submission dossiers, is reviewed. Changes in the regulatory environment increase the potential f o r standardization of documents and dossiers, and new technologies provide writers with powerful tools to implement standards more effectively. Clinical studies and development programs, however; often do not follow a standard pattern, and much that is of interest is outside the scope of standardization. Writers are still challenged to apply and adapt standards to produce coherent and clear documents that hold the readers’ attention, gain their confiaknce, and convey key messages despite the wealth of data. A tool is only as useful as the craftsman who uses it. Medical and technical writers are crucially important to the correct application of these tools and optimizing the flow of health care information. The new technologies help sharpen the distinction between the more intellectual and the more technical elements of creating documents and dossiers. Medical writers in some environments may be involved in both aspects, but the increasing complexity of the technology may lead to subspecialization. Standards are in continuous development and always require interpretation. Experienced medical and technical writers, who during their daily work must apply internal and external guidelines to real-life documents. and who are sensitive to the limits of standardization, can and should take the lead or make major contributions when it comes to developing and interpreting standards for medical and technical documents. Information technology has opened the door wide to an explosion of health care information and placed more demands than ever on writers who can, in the words of Bob Bonk, “capture, meld, disentangle, juxtapose, and reassemble biomedical information into logical packages for varied audiences” (1). Key Words: Medical and technical writing; Standards; Medical writers; Regulatory ~~
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