The Handbook of Clinical Trials and Other Research

The Handbook of Clinical Trials and Other Research. Earl-Slater A. Oxford: Radcliffe Medical Press Ltd.; 2002. 358 pages.

In chapter 3 in his classic work Clinical Trials: A Methodological Perspective (¹), Steven Piantodosi writes that research and practice are inseparable. He is right when concluding that trials are ethical in the setting of uncertainty.

Uncertainty obviously remains; hence, more good clinical trials are needed. For both readers and study coordinators, there are several books dealing with research in general and clinical trials in particular. In this review, I focus on Earl-Slater's The Handbook of Clinical Trials and Other Research (²), but in Table 1, a few alternatives are also listed (^1,3), including the (revised) CONSORT website (http://www.consort-statement.org/revisedstatement.htm; accessed January 29, 2003).

Table 1

LAYOUT

Earl-Slater's book is thick. It contains a large number of entries, which are supposed to be read separately. This is not a book that is read from cover to cover; it is a dictionary. This stands in contrast with Friedman et al.'s (³) and Piantodosi's (¹) books, which the reader may find more attractive in outline. In their books, chapters are well put together and it is easy to go through ethics or bias and random errors. Earl-Slater's book is otherwise easily read, and facts have been scrutinized by an expert advisory panel. Each entry is followed by a number of cross-references for those wanting to read more. The book contains many references to scientific papers.

There is an abundance of flowcharts and tables, among them the nowadays mandatory CONSORT flowchart, which also may be found at the CONSORT web site (see also the paper by Egger et al. (⁴)). Pictures are few but clear.

SIZE

As mentioned, this book is thick and perhaps difficult to carry; it is a book for the bookshelf. Those looking for a thin, easy-to-carry book should ponder buying the lightweight book by Sackett et al. (⁵), instead (Evidence-Based Medicine. How to Practice and Teach EBM). However, these books do not really compete. The book by Friedman et al. (³) is easy to take home for the weekend, whereas Clinical Trials by Piantodosi (¹) is more or less the same size as the book by Earl-Slater.

CONTENT

The content is The Handbook' s major strength (and perhaps weakness). My impression is that the author wanted to cover everything. To give the readers of JPGN a feeling for the content of this book, I have put together a table with the first (or the first possible) term under each letter in Earl-Slater's book using the acronym JPGN (Table 1). I also list three terms that I consider of importance to those reading papers on clinical trials (Table 1):blinding, allocation, and absolute risk. As can be seen, entries such as jack-knife or gambler's fallacy are seldom found in medical journals, and I am afraid that the inclusion of these terms may distract rather than help users of The Handbook (²). As for the entry National Institute for Clinical Excellence (authority in the United Kingdom), the large number of citations in BMJ well underlines the British perspective of the book. That may be an advantage to readers from the UK and nearby, and to others may be a disadvantage. Most books in this genre otherwise originate from the United States.

Although the inclusion of some (extremely rare) topics may be criticized, the thorough description of (other) topics, which sometimes are forgotten in similar textbooks, well deserves our praise. The Declaration of Helsinki is well covered (⁶), as is the principle of patient consent and scientific misconduct (⁷). To JPGN readers however, it may be of interest to know that very little is written about principles of research in children (see instead the article by Smyth and Weindling (⁸)).

I enjoyed reading the list of ten ways to cheat with statistics. Cheating with statistics is a popular topic among writers of handbooks (⁹) and papers on methodology (¹⁰).

Earl-Slater's review of what happens to medical studies is also very interesting (see also Ray et al. (¹¹)). All trials are of course made up in someone's mind, some of them are even performed, fewer submitted and published, whereas only a small number ultimately will influence medical practice.

Finally, I find Earl-Slater's discussion of sample size noteworthy. Not only must power calculations underlie one's sample size determination. It is also good to be aware that it is sometimes hard to gather the funds needed for large-scale projects.

Unfortunately, we are all bound by financial restrictions. Who does not long for the day when time allocated to research can be spent on actual research and not on grant applications?!

SUMMARY

Earl-Slater has written an all-encompassing dictionary on research terms. Almost every imaginable term in medical research methodology is explained clearly in this book. For those looking for a dictionary with sometimes short, sometimes extensive explanations, The Handbook is an excellent choice. The Handbook of Clinical Trials and Other Research (²) is, however, not a common textbook and is therefore not suitable for introductory courses in medical research methodology or for JPGN readers looking for a book where clinical trials are explained the traditional way (1. Ethics; 2. Design; 3. Bias; 4. Objectives and endpoints, etc.).