It’s All About Changing Practice Each and every step along the drug-development path must focus on the end game — to define the place of a new drug in practice, and then to communicate the data clearly and consistently using all available channels. But can companies make themselves heard in this overstimulated world? One of the most influential channels at a company’s disposal is the time-honored tradition of disseminating data through conference presentations and publications in peer-reviewed biomedical journals. This process is so central to contemporary drug development that it even has its own name — publication planning. Executed correctly, a company’s publication plan can dramatically impact the postlaunch adoption curve of its drug. Getting The Word Out Through publication planning, there is no better way to get the word out years before approval, and through such authoritative media. Ample research confirms physician preferences for receiving biomedical information. Whatever the source, be it PERQ/HCI or Nielsen data, conference presentations and publications in peer-reviewed journals are almost always two of the top three physician choices. Yet almost all of this information is overkill to the busy practitioner. Remember, only 1% of the data might make a difference in practice. There are several ways that companies can ensure that their critical information is among this select group. Publication planning is a sophisticated process, but here are some simple rules to get started. A Scientific Foundation Physicians at all levels are becoming increasingly sophisticated at separating substance from sizzle, and facts are what they are after. A growing number of increasingly influential groups provide physicians with practical tools to help accomplish this goal — such as the ACP Journal Club and similar journals, or the Cochrane Collaboration. Companies need to resist the temptation to gild the lily; it’s a sure-fire way to keep their submissions among the 99%. Get it Right, Right From the Start Some of the challenges that surface later in the process can be avoided through clear contract and protocol negotiation. There are very clear rules about who can be an author, and these individuals should be agreed to up front, at least for the primary abstract and journal publications. Keep it Simple Readers are looking for clear, accessible communication. Their goal is to glean the maximum amount of useable information about a study in the shortest possible time. In practice, most readers first scan the abstract to determine if the article is of interest (and most of the better journals require detailed, structured abstracts to facilitate this process). If the article piques their interest, they will then scan the introduction and discussion sections, and sometimes seek greater detail from the results section. When preparing a draft, ask this question: “If I read nothing else, what would I get out of this?” This question should be asked for each critical section. A Protocol is a Terrible Thing to Waste There are two important considerations to keep in mind when preparing a submission. First, carefully track when and how information from each protocol is disseminated to make sure that no opportunities are missed and that the protocol is not overexposed. Second, at least if your company wishes to be among those that are embracing the wishes of the medical community, publish the results from “negative” studies. “Salami” Publication Sure, everybody is excited by a successful study, but avoid redundant publication (the term “salami” appears in the instructions to authors for several leading journals). Include a unique identifier of the study results that are being reported. This enables those preparing a systematic review of the literature to accurately track multiple publications for the same results, and complies with the spirit of the requirements of most leading medical journals. Publication planning is like a jigsaw puzzle. The “picture” of the completed puzzle is derived from the anticipated results of the clinical-development program. It outlines the features and benefits of the novel compound and helps to guide its place in practice. Each publication or presentation that is successfully executed is a piece of the puzzle, so carefully track every piece against the desired profile to make sure that the results are clearly and consistently communicated to all target audiences. By following these simple rules of successful publication planning your publications are sure to be among the crucial 1%. Only 1% of everything that is published in the biomedical literature makes a difference in practice. Tim Bacon President and CEO Marketing PeerView Inc. PeerView Inc., Yardley, Pa., is an independent life-sciences/information-technology company that provides innovative, Web-based applications to support biopharma companies and their medical education and communications agencies as they prepare and execute publication programs. For more information, visit epeerview.com. May 2005 VIEW on Biotechnology
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