Human pharmacology trials study designs

Whereas the care devoted by Kraepelin to the individual assessment methods was in some contrast to the more loosely handled experimental design and conditions, great importance nowadays is laid on details of design and statistical analysis of human pharmacological studies. The most important elements in the organization of such trials are ... 

CSline. CSline [84] provides information on well-designed and well-executed clinical trials of drugs currently under study or in use in humans. This information includes study objectives, design, population, intervention groups, withdrawals, adverse reactions, endpoints and results, conclusions, and references. The CSline database covers more than 500 drugs currently on the market or in development. Pharmacological data from more than 2000 journal articles, congresses, and books are added each year. The product is commercially available on CD-ROM from Prous Science and is updated every 2 months. 

The design and the execution of safety pharmacology studies are focused upon the safety of human volunteers and patients in clinical trials. ICH S7A and may be soon S7B strive for effective integration of safety pharmacology results with those of the non-clinical (toxicology) and clinical safety databases. 

As micronutrient deficiencies more or less ceased to be a large pubhc health problem in Western countries, the attention of scientists and manufacturers turned towards the many other functions that vitamins have in human metabolism. For the last several decades, pharmacological doses of most vitamins have been claimed to be of therapeutic value in a wide variety of conditions, which have only a superficial resemblance to the classic vitamin deficiency syndromes. The literature on which many of these claims are based unfortunately often consists of poorly conducted clinical trials or anecdotal reports. Properly designed studies are relatively few in number. No authoritative body has proposed quantitative recommendations or reference values for public health policy. 

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