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Fig. 3.20. Data Publications & Presentations

Fig. 3.20. Data Publications & Presentations podium verbal presentations, and then later full publications. All such presentations are refereed by other independent experts, assessing the design of the studies (at least, appropriateness, quality, and novelty), the data and observations, and the conclusions. The publications will take several forms: the original research paper for the study to be published in a medical journal, review articles summarizing the product's use in a disease published alone or in journal supplements for the disease or drug category and later in book chapters about the disease or drugs [32].

Educational materials are developed by a company during the clinical research phase for a new product, and, of course, especially after a product is marketed (Fig. 3.21). The most significant educational document produced by the development (clinical research) group is the investigator's brochure (IB), which is prepared by all companies for a new product while their clinical trials program is being done. The IB is a summary of all primary data from the animal studies, metabolism, clinical trial summaries, and formulation data, in order to educate the investigators and their institutional review boards for patient safety. Certainly, safety is the most significant focus followed by product activity and efficacy, up to that point in time. Any other indications or studies in process for other indications need to be discussed in the IB also. This document must be updated regularly as new data on the product comes to light through the clinical trials or other research. Prior to marketing, investigator meetings will be held to educate them about the various properties, safety, and uses of the new product, as well as training about the new protocol being initiated. The principal investigators, co-investigators, and study coordinators are all trained with the new protocol and its requirements, especially for patient enrollment, study conduct, and monitoring. If the product is novel and a major advance in science and patient care, symposia also are conducted by groups of scientists to advance the scientific dialogue, share information in the medical community, and receive input about the potential role of the product in patient care for the target disease(s). The programs must be independent of the company control for legal, regulatory, and ethical reasons. The company may create slide materials about the product and protocols for educational use by the investigators. Monographs are produced about the product and the disease related to the new discoveries to educate the medical community. Administration guides might be required for products with novel or more complex methods of administration. As part of the approval process, the R&D organization needs to prepare a patient package insert to explain how to use the product to obtain optimal benefit, including not just administration

r Investigators brochure

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Project Management Made Easy

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