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Missed Opportunities in the Review and Revision of Clinical Study Reports
Abstract
Circulating written drafts and conducting roundtable reviews are two important document-development activities in many work sites. Previous studies suggest that review processes are frustrating for participants and have substantial inefficiencies caused by conflicting participant purposes. This article presents two case studies of the document-review practices for clinical study reports from a large pharmaceutical company, paying particular attention to whether review efforts contributed to improvements in document quality. Findings suggest that document review did not lead to demonstrable improvement in report quality. The authors offer recommendations for improving document-review practices.
... Relatively little work in rhetoric or technical communication addresses regulatory documentation. A notable exception is Cuppan and Bernhardt's (2012) analysis of study report authoring and review. Their entry draws on their critiques of the writing and argument quality in these reports and suggestions for better documentation processes. ...
... Moons (2015) recommends a process for medical writers producing patient safety narratives (Figure 1 shows a simplified version) in any country or language. Of note, this narrative review process occurs before the clinical study report review described by Cuppan and Bernhardt (2012). Audience expectations of patient safety narratives include factual accuracy and conciseness, while institutional expectations include quality control and approval by qualified experts. ...
Patient safety narratives are a globally mandated format for representing individual patient experiences, and they include peer-reviewed case reports and narrative medicine. The authors show how the humanistic values described by Carolyn Miller in 1979 could enhance or contribute to international health and medical communication in relation to such narratives. They do so by expanding on twenty-first century work by Bowdon and Scott to provide a framework for considering how narrative competence and narrative humility may allow technical communicators to strengthen their practices within technical communication and the rhetorics of health and science by examining an individual problem within its broader, intercultural contexts.
... Comments management techniques 1,13 Too many reviewers can lead to conflicts and contradictions. An RMW can propose to minimise the number of reviewers (one subject matter expert per function) during the peer review. ...
Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review processes along with different stakeholders. Poor peer review leads to protocol amendments, which delay regulatory submission and increase project costs. Thus, there is a strong need for RMWs and stakeholders to work together during the peer review process to highlight the specific issues that should be addressed before finalisation, which helps in creating effective, efficient, and high-quality protocols. The suggested protocol peer review steps described in this article will help an RMW to plan, coordinate, and deliver this highly important document for global and local clinical trials.
Published in CIDM Information Management News (May 2013).
This article is a follow-up to the "Results of the 2012 Best Practices Research Needs Survey" article in the April issue of the CIDM e-newsletter. Here, I discuss the value of a reciprocal relationship between research and practice and suggest that the time might be right to form a new habit of collaboration between industry and academia. Research approaches and design possibilities and strategies for overcoming empirical research challenges are also discussed.
We are all patients in some way---or, at the least, patients-in-waiting. Although I am reminded of this reality on a daily, if not hourly, basis, it is most apparent when I log onto the Internet to engage in what millions of users have begun doing in the last few decades: surf for health information. Typing in "breast cancer" for what must be the thousandth time, I look again for research that will provide insight into this biopolitical phenomenon. Perhaps more telling, I search for information about my own body. As I scan the material, I cannot help but ask myself what qualities I possess or have developed and how they fit into the categories of "high risk," "moderate risk," or "low to no risk."
This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef?ciency while developing clear and concise text. At all times, and irrespective of applicable laws and guidelines, good communication skills and a sense of balance are essential to adequately, accurately, and clearly describe a product’s characteristics. At no time should the reader perceive these suggestions to be the only viable solution to writing regulatory documents nor should the reader expect that these suggestions guarantee product success. The audience for this book is the novice medical writer, or those who would like to explore or enhance regulatory-writing skills. We assume the reader will have a basic understanding of written communication, but little experience in applying this skill to the task of regulatory writing. Extensive knowledge of science, clinical me- cine, mathematics, or regulatory affairs law is not required to use the best practices described in this book.
Document review practices in the research and development functions of many pharmaceutical companies can be frustrating and inefficient, at least in part because these practices are poorly managed. Although the literature on review practice is fairly robust, there is a disjuncture between what researchers know and how reviewers work. The author draws on his experience as a consultant and trainer to many pharmaceutical companies to outline the causes and effects of poor review practice. He offers recommendations to enhance the value and increase the efficiency of reviews.
This article reports findings from a study of writers and reviewers in two complex organizations. The author analyzes the differences between the content, conduct, and resolution of document reviews mediated by hard-copy text and those mediated by textual replay (a series of screen-captured images of the writer’s on-screen writing activity) plus hard-copytext. The results show that reviews mediated by textual replay directed greater attention to issues concerning writing and revision processes. The reviewers offered more tentative revision suggestions and more often enlisted the writers’ participation in articulating, proposing, and implementing the revisions. The article concludes by considering ways that textual replay could be further designed to support the range of joint activities that document review comprises.
In this article, the review process is described as a method of formative evaluation of texts. The description is based on three empirical studies of professional writing practices. It includes the goals of review, the actors involved in the process, the moments in the text production process that review is taking place, and the procedures followed. The studies make clear that review serves more goals than just improving the text. For improving the text, other methods than review probably produce better and more reliable results, especially when the goal is to improve the usability of the text. But review also has the function of having the information checked by experts and of building consensus and commitment in the organization. Because in most organizations review is taking place anyway, all remarks about the quality and acceptability of the document that are collected in the review process can be considered additional information that writers could use—with caution.
This article argues that engaged "action research" can help professional writing re- searchers both develop new and interesting collaborative models and help our profes- sion develop a greater relevance to those not reading our journals and attending our conferences. I outline one particular, localized approach in the hope that our troubles, struggles, and failures at University of Wisconsin-Milwaukee can help others to de- velop their own programs and can further our discussion of community engagement.
Discusses the development of a pragmatic model of the writing process in the workplace, focusing on the importance of "drafting" as part of that process. Discusses writers' attitudes about drafting and the structures of the workplace that drafting has to accommodate. Introduces a drafting model and discusses results of using this model in the workplace. (SR)