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Thursday, August 26, 2010

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Clinical Trials in Oncology, Second Edition Review



I should begin by admitting that I had the opportunity to review this little masterpiece in manuscript. Good then, it's even better now.

It's good because it informs the reader, in sober prose, how to determine what works and what doesn't in medical practice, and what's safe and what isn't. It's good because it reveals what can go wrong when anecdotes ("it worked for me!") substitute for sound research as the basis for clinical practice. And it's good because it shows how serious are the consequences of even subtle failures to observe protocols in designing and carrying out clinical trials.

It is reassuring to read of the care and precautions advocated for government-sponsored research; it is accordingly unsettling to contemplate the pressure that commercial interests (drug companies, for-profit hospitals, equipment manufacturers) might bring on researchers to cut a few corners.

After reading "Clinical Trials" I came to appreciate that case studies, longitudinal studies, and retrospective questionnaires, so frequently hyped in the press and on television, are no substitute for actual well-designed and well-executed experiments. Because you and I are different, certainly genetically and probably in other essential ways, what helps you may well harm me. Only the proper application of statistics in designing clinical trials and in analyzing data from them can distinguish what's generally valuable from what's useless (however plausible and authoritatively touted it may be). Although the authors had the good taste to reject the aphorism, usually attributed to a nameless statistician, that "if experimentation be the queen of science, then statistics stands as the guardian of the royal virtue", its pithiness may give the reader the crucial insight into why alternative modes of research are untrustworthy.

Some readers may feel disheartened to learn the truth that many, probably most, promising therapies prove, when adequately tested, worthless, and some may feel in some fuzzy way that to accept this reality is cruelly to deny hope to those who need it badly. On the contrary, this book makes it clear that to offer false hope is the ultimate cruelty, for without experimentation there can be no knowledge, and without knowledge there can be no real hope.

Notwithstanding the slightly technical nature of this book (yes, there IS a chapter with mathematics), I recommend it highly for the general reader who is interested in such topics as personal health care, alternative medicine, managed care cost containment, and the like. Buy a copy for yourself, and, if you feel philanthropic, you might consider donating a copy to your health care provider. The world would be better if doctors' waiting rooms (like hotel rooms with their Gideon Bibles) all had a copy of "Clinical Trials in Oncology" available for patients' perusal.




Clinical Trials in Oncology, Second Edition Overview


Studies that are unimpeachably thorough, non-political, unbiased, and properly designed… These are the standards to which everyone in clinical research aspires. Yet, the difficulties in designing trials and interpreting data are subtle and ever present. The new edition of Clinical Trials in Oncology provides a concise, nontechnical, and now thoroughly up-to-date review of methods and issues related to clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the major pitfalls that are seemingly inherent in these processes. This edition includes a new section that describes recent innovations in Phase I designs. Another new section on microarray data examines the challenges presented by massive data sets and describes approaches used to meet those challenges. As always, the authors use clear, lucid prose and a multitude of real-world trials as examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Although the book focuses on cancer trials, the issues and concepts are important in any clinical setting. Clinical Trials in Oncology, Second Edition works to improve the mutual understanding by clinicians and statisticians of the principles of clinical trials and helps them avoid the many hazards that can jeopardize the success of a trial.


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