Review of Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional

tions are often followed by slightly different questions that serve to broaden the discussion. It is a large work: 811 pages, including a main section of questions and answers about clinical trial requirements in the US; a large section with questions and answers about clinical trials and GCP standards in Europe, South America, India, China, and Russia; and a large section containing the full text of applicable FDA regulations and guidances, as well as ICH guidances. It also has chapters on GCP regulations and guidelines, requirements for investigators, for sites, issues related to Form FDA-1572, clinical trial monitoring, informed consent, source documentation, clinical trial protocols, institutional review boards, safety reporting, FDA inspections, computerized records, patient recruitment, subject diaries, conflicts of interest, fraud, and the impact of the Health Insurance Portability and Accountability Act on clinical trials. For example, there is a 6-page discussion in response to a series of 5 questions about whether an investigational new drug application (IND) is needed for a phase IV study of an approved drug. Under a 2010 FDA draft guidance, an IND is needed for a phase IV study if the study will be used to support a change in the drug’s indication or a change in its advertising, as well as in certain situations where safety is an issue, and in a few other specialized situations. In general, however, FDA assumes that ‘‘any well-controlled [phase IV] trial of a marketed drug sponsored by the manufacturer of the drug would be [considered to be intended] to influence labeling or promotion in some way,’’ and therefore would usually be expected to be conducted under an IND, whereas a similar study conducted by an individual investigator in an academic setting could be conducted without an IND if it was not intended to support changes in indication or advertising. A follow-up question asks what happens if a ‘‘sponsor or investigator does not intend to use the results to support significant changes in a product’s approved labeling,’’ does the study without an IND, but later ‘‘changes his or her mind.’’ The book’s answer is that as long as a phase IV study was conducted in good faith under the terms of this exemption from filing an IND, FDA will later accept it in support of an IND or new drug application. One shortcoming of the printed version of the book is that there is no index. The eBook version does have a search function that can find keywords. Thus, this book is recommended mainly for browsing, reading, or study, and the writing style is appropriately pleasant for this. I enjoyed reading many of the discussions in this book, and I was impressed by their breadth and by the fact that I could not find any errors. This probably reflects a combination of the good editing that the book must have gone through and the fact that the answers in the book are the work of an ‘‘expert advisory panel.’’