Medical Writing in Drug Development

A Practical Guide for Pharmaceutical Research

Robert J Bonk

• Publisher: Routledge
• Year: 2014
• eBook ISBN: 9781317971412
• Topic: Business
• Subtopic: Business General
• Index: Business

A guide through the maze of the pharmaceutical research and development process, Medical Writing in Drug Development fills a gap in the libraries of technical writers, college instructors, and corporate professionals associated with the pharmaceutical process. As it discusses critical information, such as strategies and techniques pivotal to crafting documents for drug development, it also overviews drug research, document types, the roles of professional writers, and information technology. In no time at all, you will be creating persuasive technical documents, building complex facts into coherent messages, and contributing to the effective marketing of new products with promotional pieces that meet legal and ethical standards.Medical Writing in Drug Development helps medical writers and scientific, regulatory, and marketing professionals develop a working knowledge of the technical documents crucial to successful drug research. New and seasoned professional writers alike will benefit from the book's detailed discussions of:

• using abstracts, slides, and posters to present up-to-the-minute research
  
• how patient-education materials, health-economic assessments, and electronic journals provide ongoing challenges in medical writing
  
• a dossier approach that expedites regulatory submissions for international drug development
  
• structural constraints and rhetorical approaches toward regulatory documents
  
• presenting intricate information in scientifically unbiased, yet technically convincing language
  
• the effects of electronic publishing, computer graphics, and related technology on the practice of medical writing within pharmaceutical research

Practical as a foundation text for undergraduate, graduate, and certificate programs in pharmaceutical or medical technical writing, Medical Writing in Drug Development will help you develop practical strategies for handling journal manuscripts, conference materials, and promotional pieces. No other text will clarify the main aspects of the pharmaceutical research and development process while offering you insight on the key issues dominating the healthcare arena.

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PART I:

MEDICAL WRITING FOR PHARMACEUTICAL RESEARCH

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Medical writing attracts a diverse group of professionals, ranging from communications specialists to laboratory scientists to healthcare practitioners. To establish common ground for this wide audience, Part I spotlights medical writing within the context of a general overview of pharmaceutical research.

Chapter 1

Basic Introduction to Medical Writing

The author should be like God in the universe,
present everywhere but in no way visible.

—Gustave Flaubert

Information explodes around us through our modern technology, and perhaps nowhere more than in health care. Recent scientific and biotechnological advances amplify our understanding of health and disease, often fortuitously with new treatment modalities. But, to be of any practical use, these advances must also be communicated to those who can use and benefit from them. New information technologies facilitate quick communication, yet confusion can also reign during information overload. How can this information burden be juggled effectively? And to our advantage?

Through healthcare communicators: specifically “medical writers” who capture, meld, disentangle, juxtapose, and reassemble biomedical information into logical packages for varied audiences. This book explores the role of medical writers in the healthcare communication process, with a particular focus on the development of new drugs.

HISTORICAL ROOTS
OF HEALTHCARE COMMUNICATION

During these past several decades of technological advancement, medical writing has emerged as a pivotal profession in the healthcare arena, particularly in the research and development of new pharmaceutical products. Paradoxically for health care, many breakthroughs developed from the carnage of war. For example, new treatments emerging from the horrors of World War II included penicillin and other antibiotics for combating infectious diseases, surgical procedures for complex multiple injuries, and psychological approaches for the emotional and mental devastation of shell shock and other disturbances (Watts, 1987).

While of value in and of themselves for the wartime soldiers, these medical advances captured a watershed moment in history as the launching pad for more sophisticated accomplishments in health care. But this fertile ground would remain barren if the information of these advances were never communicated. Not only do researchers and academicians rely on timely dissemination of scientific knowledge to feed further study, but the public needs the information to drive government and corporate support for additional advances in healthcare technology.

Much of this advancement stems from the transformation of the practice of medicine during this century: our parents and grandparents may have unquestionably accepted the physician's diagnosis, but today we may challenge this diagnosis, or at least want to learn more about our own health condition. Modern technology quickly provides us information about health, but safeguards about correct interpretation and appropriate dissemination of this key information are crucial to its effective use (Berland, 1983).

Who serves this pivotal role in healthcare communication? The medical writer. The profession of scientific or technical writing, of which medical writing is a key specialty, responded to the critical need to handle the burgeoning technological information from this historical era (Losi, 1987). The information itself grew disproportionate to the ability of its generators, the scientists, to handle it directly. Hence, writers and other information specialists became the communicators and custodians of these data so that scientists could focus on substance, thereby generating more advances. And, in some respects, medical writers became translators of this information, ensuring that correct messages would be received and understood by intended audiences, whether technical wizards, interested laypersons, or someone intermediate in perspective.

SOCIAL FABRIC OF MEDICAL WRITING

The power of the medical writer, of course, depends in large part on the information source: healthcare information is vital to everyone at some, if not all, stages of their own lives and those of their families. Moreover, because communication is a social phenomenon, the medical writer exerts indirect influence on our cultural fabric, weaving a new rhetorical landscape across communication media (Bazerman, 1991).

These cultural effects of medical writing are also evidenced by changes in literary and artistic presentations of medical themes over the past few centuries (Bazerman, 1991). Consider just the overall look of medical textbooks from the previous few centuries, with hand-drawn graphics indicating the controlling powers of humours and herbs, potions and poultices. And now compare the detailed electron microscopy of modern medical textbooks. Then peruse the self-help area of any bookstore for a layperson's guide to health and disease, and note the depth of technical detail. Moreover, while themes of health and disease populate our literary heritage from ancient times, no one can deny the keen interest of today's public in medical books, videos, and talk shows.

Through their deft handling of this information, professional medical writers exert intended—and sometimes unintended— effects on our social milieu. Information lives and breathes within our complex cultural fabric. Through interplay with other aspects and institutions of society, presentation becomes interpretation. Medical writers can therefore transform the social reality of medicine (Bazerman, 1991).

PHARMACEUTICAL WRITING AT THE FOREFRONT

Given the increasing attention, in both public and private sectors, to the segment of health care that comprises pharmaceutical products (Bonk, Myers, and McGhan, 1995), the medical writer who specializes in drug development often commands a key role. Because drugs capture a small, but personally felt, piece of our own expenditures, the seemingly high prices for “magic bullets” to cure our ailments, or at least alleviate the symptoms, force the pharmaceutical field to the forefront of public and private scrutiny.

With this focused attention comes the need for careful handling of information related to drugs. This information spans wide vistas: technical details on scientific discovery; factual compilations to support government licensure for marketing; educational pieces for the medical community and, more commonly, the patient; and even advertising to keep healthcare practitioners aware of new advances. Thus, within this scope, the medical writer who specializes in the pharmaceutical discipline plays a pivotal role in healthcare provision.

Exploring this important role of the medical writer in communicating drug information, this book provides a practical guide for the new and not-so-new professional. Not a style guide, this book is a working map for the craft of medical writing.

Chapter 2

Overview of Drug Development

The circumstances for sustained creation are almost impossible.

—Tillie Olsen

“Take this antibiotic three times a day for ten days; don't stop because you feel better!” “Nurse, set up an IV drip for this oncologic agent; watch carefully for signs of nausea.” “You need to take this medication every morning, to keep your blood pressure down.”

Three very different scenarios for prescribing a drug. Yet, all three drugs would have passed through the same basic set of requirements for marketing approval from the Food and Drug Administration (FDA) in the United States, including types of regulatory documentation required for that approval. How can that be?

Understanding the pharmaceutical research and development process, with a special eye on the underlying documentation, is perforce a requisite of professional success in medical writing. Through deliberate focus, this overview clarifies main aspects of an operationally complex process, so that the rhetorical strategies detailed in subsequent chapters will gel for the medical writer.

REGULATION OF THE DRUG PROCESS

Several excellent references provide the source information for this delineation of the research and development process for a new prescription drug. These references include documents issued by the government for the typical consumer (Pines, 1981; U.S. Department of Health and Human Services, 1981), as well as comprehensive texts that target pharmaceutical scientists (Spilker and Cuatrecasas, 1990; Smith, 1992). Consult these guides, as appropriate, for further exploration of the steps in the drug development process, as overviewed in this chapter.

Each country (or group, such as the European Community) maintains a regulatory agency to govern the approval process that allows new drugs to be marketed for specified diseases or therapeutic indications. In the United States, this agency is the FDA. For simplicity, this chapter focuses on the drug development process as typical for the United States under FDA regulation. Other countries follow comparable guidelines, particularly with the move to harmonization of all international regulations for drug development (Nightingale, 1995; further discussed in Chapter 7, “Foundation Reports of Research Trials”).

In the United States, the current drug regulations developed o...

Table of contents

• Cover
• Half Title
• The Pharmaceutical Products Press
• Title Page
• Copyright Page
• About the Author
• Table of Contents
• List of Figures
• List of Tables
• Foreword
• Preface
• Acknowledgments
• Part I: Medical Writing for Pharmaceutical Research
• Part II: Regulatory Documents for Drug Submissions
• Part III: Pubiication Documents for the Medical Community
• Apendixes: Templates for Medical-Writing Documents
• References
• Index