Ton J. Cleophas M.D., Ph.D (auth.)'s Human Experimentation: Methodologic issues fundamental to PDF

By Ton J. Cleophas M.D., Ph.D (auth.)

ISBN-10: 0792358279

ISBN-13: 9780792358275

ISBN-10: 9401146632

ISBN-13: 9789401146630

Despite their effectiveness within the assessment of latest pharmacological compounds, managed scientific trials are often insufficient. utilizing info from the literature in addition to from the author's personal event with scientific trials, Human Experimentation: Methodologic concerns primary to scientific Trials addresses such inadequacies and attempts to supply strategies. This paintings is the 1st to completely study those unsolved inadequacies and issues of the layout and the execution of scientific trials and, extra importantly, to supply ideas for those difficulties. it's important for a person who's all for scientific learn: clinicians, pharmacists, biochemists, statisticians, nurses, sponsors, etc., and somebody who's thinking about utilizing result of study to sufferers, i.e. physicians.

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Palliative care is considered to be different from symptom-based management in that the former is supposed to deal with issues in the management of terminally ill and the latter is related to a variety of ailments suffered by the person [14]. The hospice literature usually embraces the former and no literature by and large has taken up the latter. Also, quality of life studies are considered to be different [15,16]. Although they focus on symptoms and adverse effects,they do so in the context of treatments given for indications other than the relief of such symptoms, for example, the remission of cancer, or the reduction of blood pressure.

2. In other study designs no test is available. So, clinical arguments and alertness for unexpected patterns in the data are the only defenses against it so far. 3. Dose response, dose titration, and open evaluation studies should require sufficient washout periods between the administrations of the drugs. Even 14 plasma halftimes may be required. 4. Studies using of duplicate standard deviations should always be combined with a statistical test for differences between the duplicate data. If a significant difference is detected, the use of duplicate standard deviations for the estimation of intra-individual reproducibility has little value.

Does this mean that they are a failure? In a sense it does. At least such studies do not confirm our prior beliefs, which was the main reason for performing the study in the first place. If the data do not allow to reject the null hypothesis of no treatment effect compared to control we have to think hard about something that may have gone wrong. For example, 1) samples were too small, 2) biases may have entered the study, 3) study designs may have been inappropriate. The present paper focuses on a particular aspect of study designs that may be sometimes inappropriate.

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Human Experimentation: Methodologic issues fundamental to clinical trials by Ton J. Cleophas M.D., Ph.D (auth.)

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