Prerequisites for Phase I and II Clinical Drug Trials in Human

Bourin, Michel

doi:10.15226/2374-6866/3/1/00137

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The Need To Maintain the Comparability Resulting From Random1

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2017

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“…As a result of all these constraints, the crossover scheme is rarely used in phase III trials, but rather in phase I or II [5]. However, it is possible to consider it for phase III in certain specialties such as ophthalmology, when the pathology concerned involves both eyes, and dermatology, when several lesions exist simultaneously, provided that the treatments studied involve no systemic route.…”

Section: The Need To Maintain the Comparability Resulting From Randommentioning

confidence: 99%

Planning Clinical Trials: The Main Step in Developing New Drugs

Bourin¹

2017

SOJPPS

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A therapeutic trial is generally conducted to determine a new treatment or improve therapeutic applications. Several crucial questions should be considered before the trial is undertaken. The planning of a clinical trial involves a succession of steps intended to develop a protocol providing a clear and unbiased answer to a precise therapeutic question. What treatments are to be compared? What type of population should be studied? What are the evaluation criteria? What is the most suitable experimental scheme? How many patients should be included? What statistical procedures should be implemented (single analysis, intermediary analysis, serial analysis)? This paper considers briefly the main points to be resolved at each planning stage.

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Section: The Need To Maintain the Comparability Resulting From Randommentioning

confidence: 99%