By Derek Pearson, Colin G. Miller
The second one revised and up-to-date variation of "Clinical Trials in Osteoporosis" is a pragmatic guide on scientific trials within the starting to be box of osteoporosis. themes coated comprise research layout, technical concerns, info assortment, caliber coverage, info research and presentation. It takes the person in the course of the approach step by step from begin to end, additionally delivering a heritage on regulatory instructions, moral implications, endpoints, present cures and the best drug to use.
"Clinical Trials in Osteoporosis" is meant to function a realistic guide for clinicians and scientists coming to the topic new and to supply a typical for latest facilities to degree themselves opposed to.
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Extra resources for Clinical Trials in Osteoporosis
Rather than use a coin, it is simpler to use random numbers generated by a computer. A separate randomization list should be held for each centre to avoid confounding factors such as a large proportion of the trial subjects at one centre entering the treatment group. The advantage of simple randomization is that the treatment allocation is unpredictable. Conversely, there is a danger that there will be unequal numbers in the treatment and control groups. 17 The aim of block randomization is to ensure that there are equal numbers of subjects in the treatment and control groups.
However, this position raises the question of ethics regarding the acceptability of treating subjects in one country rather than another when it comes to clinical trials. We do not have a uniform world in terms of health policy and each country has its own view of health and its treatment. Therefore, it might be possible to perform trials ethically in one country and not another, although any sponsor has ethical and moral responsibilities in the planning of a trial, regardless of the country in which it is conducted.
Many CROs require BMD results to be analysed by a central laboratory and will set up arrangements for the transfer of original scan data and DXA quality control data by optical disk or CD ROM. There must be good logistical arrangements for the prompt transfer of data, to ensure that any problems with the data are ironed out as soon as possible after the scan visit. It is important, however, for centres to review DXA scans immediately after acquisition to ensure that they meet basic quality criteria for subject positioning, image artefacts, and data analysis (Chapter 7) because a repeat scan is sometimes necessary.