Clinical Evaluation of New Drugs Edited by S. O. Waife and Alvin P. Shapiro (review)

Clinical Evaluation ofNew Drugs. Edited by S. O. Watfe, M.D., F.A.C.P., and Alvtn P. Shapiro, M.D. New York: Hoeber-Harper, 1959. Pp. xii+223. $7.50. The highest praise for a book is that it merits the shortest possible review: "Buy it." This book deserves that brevity. To answer the questions "Who should buy it?" and "Why?" I find myselfagreeing with the statements on thejacket—a somewhat rare experience . The book should be studied by "all who have aninterest in newdrugs," whether theyare investigators inclinic orlaboratory, practicing physicians, house officers, or medical students—all those who desire criteria bywhich theycanjudgehowthoroughlyanew (or even an old) therapeutic agent has been tested. To this list I would add the professional statisticians who, in increasing numbers, are becoming involved in medical research. The formatis enticing, and the chapterheadings demonstrate the widescope ofsubject matter and treatment. Part I, "Principles of Drug Evaluation": "Statement ofthe Problem " (Waife); "Pharmacologic Problems" (Beyer); "From Animals to Man" (Severinghaus ); "Experimental Design and Statistical Problems" (Lasagna and Meier); "Placebos and the Evaluation ofthe Subjective Response" (Beecher); "The Ethics ofExperimentation on Human Beings" (Bean); "Human Beings as Experimental Subjects" (Wolf);"The Training of the Investigator" (Ingle); "The Investigator Himself" (Shapiro). Part II, "Clinical Trials in Practice": "Introduction" (Shapiro); "Infectious Diseases" (Dowling); "Cardiovascular Disorders" (Shapiro); "Gastrointestinal Diseases" (Machella); "Nutrition and Metabolism" (Waife); "Endocrinologie Problems" (Gabrilove); "Neuropsychiatrie Disorders" (Kline); "Problems ofPublication" (Waife). Each chapter reveals how well selected were the authors for their respective topics, not only because oftheir experience, but because oftheir awareness ofthe numerous difficulties and unsolved problems in the infant art ofcontrolled clinical trials. To those ofus who are inthe midstofsuch trials, especially multiclinictrials, andwho arefrequentlydepressed bythe vastexpenditure oftime, labor, and money inourefforts to develop an art inwhich the principles are so simple and thepractice so difficult, this book brings not onlyideas—in the text and in the well-chosen bibliographies—but encouragement, for the authors present numerous concrete examples, not only oferrors and disasters, but ofsuccessful efforts to avoid them. Although the application ofthe principles ofdrug evaluation must be tailored to suit each type ofdisease, the rheumatologistor cancer therapist should not ceasereading when he reaches Part II, nor should any other specialist who does not find therein a section dealing withhis speciality. Bythoughtfulreadingofallthese chapters, he will find suggestions transferable to his own field. For example, I was interested to note many opportunities of transfer from the chapter on neuropsychiatrie disorders, in which I have no direct experience ofclinical trials, to other fields where I have such experience. Ifevery one who came to my department for consultation in a clinical trial (and even in many other types ofexperiment) would previously read this book, I would rejoice so greatly that I would be willing to risk being confronted by the sweeping declaration of faith in Herr Gauss on page 58. (I hope, however, that when a laboratory test is made on one ofmy body fluids or tissues, my physician will not take too literally the statement on 441 page 190 that "data obtained in testing many biologic phenomena follow a normal distribution curve.") Doubtless any clinician or biometrician who has been a coordinator (that is, troubleshooter ) in a multiclinic trial will think oftypes ofproblems that he would like to have seen discussed—for example, the type illustrated by a letter that arrived in the middle of this review. A participant in a trial, where observations were required every seven days, wrote as follows: "The due date is October 8, but the observer will be absent on that day. Shall we use another observer on October 8, or shall we postpone the observations until October 12, in order to have the same observer throughout?" To discuss such questions as this, we need still more articles and books, written with the same attitude as this one—the attitudeoftwo pioneers inclinical trials, Bradford Hill, the statistician, and Marc Daniels, the physician. One of our most experienced American medical statisticians once remarked, to a research planning committee: "We may spend several million dollars on this project, but Bradford Hill would do a betterjob with a hundred thousand dollars, because he would first sit down and think." Regarding cooperative clinical trials, Daniels...