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The Handbook of Clinical Trials and Other Research
  1. P Hungin

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Clinicians are notorious for embarking upon research without a full understanding of methodology. Perhaps in the past clinical journals were guilty of publishing papers without being sufficiently critical. No doubt this was a byproduct of well meant refereeing by clinicians who were themselves hamstrung methodologically, and lacking insight.

In the new world of publications, the research design has to be explicit, well laid out, and sufficiently robust to support the research reported. Most doctors have had little or no training in research methods, despite having completed an MD. This might be one reason why it is becoming increasingly difficult for even research experienced clinicians to initiate new projects. Indeed, there is a question mark as to whether research can now be done by service based clinicians or whether, because of the newer strictures and disciplines, this should be left to the professional researcher. Perhaps the answer is that clinicians ought to have access to experts who can not only guide them but see them through the entire project. Some have questioned whether clinical research is still possible—the answer, even if only in hope, is yes, but this will require a greater familiarity with research methodology, the patience to plan thoughtfully, and with experienced counsel.

This handbook provides definitions and contemporary examples. It provides recent references from major journals and is well illustrated. It contains material beyond explanations of research terminology and methodology including the new requirements for the Research Ethics Committees, and the EU Clinical Trials directive. Many of these areas are fast moving; in the UK there is a single electronic ethics application form now with new rules regarding consent for multicentre studies. The only way to keep up to date with many of these developments is to search the appropriate website.

It is a challenge to create a tool that is expected to be appropriate for people with different levels of knowledge and experience. This publication is certainly straightforward to use and is a useful repository of terms and other sources of information. I am glad I have my copy but can you really teach old dogs new tricks?

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