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A Concise Guide to Clinical Trials

by Allan Hackshaw

4.00 · rating details · 1 rating · 1 review

Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgica...more

Paperback, 215 pages

Published April 10th 2009 by Bmj Publishing Group

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Nov 25, 2011

Adam Wiggins rated it

This book appears to be the most accessible book on the subject of clinical trials available today. Even so, the content is dry and academic -- I was able to make it through because I have a particular interest in the topic.

Clinical trials are the application of the scientific method to a medical treatment. The goal is to provide evidence, either position or negative, of the benefits and side-effects of a given treatment. The first clinicial trial was done by James Lind in 1747, whi...moreThis book appears to be the most accessible book on the subject of clinical trials available today. Even so, the content is dry and academic -- I was able to make it through because I have a particular interest in the topic.

Clinical trials are the application of the scientific method to a medical treatment. The goal is to provide evidence, either position or negative, of the benefits and side-effects of a given treatment. The first clinicial trial was done by James Lind in 1747, which showed that six sailors given a daily concoction which included oranges almost completey recoered from scurvy during their sea voyage, as compared to six sailors on the same voyage who did not receive the treatment.

Often the purpose is to show that a particular treatment is equally effective as an existing treatment, but with other benefits (lower cost, easy to adminster, higher quality-of-life for the subjects).

Trials typically happen in three phases: Phase I (basic human safety checks), Phase II (show potential benefits on a small group, e.g. 20 - 50 subjects), and Phase III (show benefits on a statistically-sigifincant scale, e.g. hundreds or thousands of subjects).

Nearly every aspect of clinical trials, from the design to the publishing of results, is the disciplined application of scientific rigor. The goal is to minimize bias (assumptions of the administrators or patients of the outcomes) and confounding (unrelated variables that skew the results). Trials should be double-blind (neither the subject nor the administrator knows whether they got the treatment or a control), using randomization techinques to ensure truly random distriution. Use "pack code" identifiers to be able to track which sample was administered to which subject while maintaining the blinding. For example, the first subject might get pack code ID001, and the second subject might get pack code ID002. A database with the mapping from pack codes to treatment vs placebo is stored elsewhere for use in tabulating the results later.

Selection of "outcome measures" or "endpoints" is critical. What are you actually trying to measure? There should be one key endpoint -- for example, in the scurvy trial, the health of the gums of the subjects at the end of the trial. The outcome should be clinically relevant to both the administrators and the subjects. Endpoints may be measured by counting people or by taking measurements on people.

The book does its best to assume no prior knowledge of stastitics, but a huge portion of trial design and execution is the application of statsitics. One would get lost fairly quickly without knowledge of basic statistics, such as computing means and medians, standard deviations, confidence intervals, and p-values. The book also covers some fancier stasticaly tricks, such as the Kaplan-Meier plot, which allows integration of incomplete data in a statistically valid fashion. For example, a study of on a drug to treat heart disease might want to track subjects for five or ten years past the end of the drug's administration to determine average lifespace of the group who received the treatment vs the placebo. The reality is that some of those subjects will fall out of contact with the researchers, but the Kaplan-Meier plot lets you plug in the last know alive date for each subject.
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Jul 22, 2011

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