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Master Thesis

Méthodologie des essais cliniques : entre obligations réglementaires et urgence sanitaire

Abstract : A Chinese proverb says "A fixed method is not a method". However, Humanity has worked for centuries to formalize the methodology of clinical trials within the various regulatory frameworks. The formalization of ideas, the structuring of steps and the implementation of methodological standards have enabled, over the centuries, to reach an international scientific consensus on the obligations to be respected. These prerogatives ensure patient safety within the trial, but also the obtaining of reliable and robust results so that the scientific and medical community can rely on a solid base of knowledge. However, this firmness of application cannot be applied in times of health emergencies. When time is short, when lives are at stake, it is imperative to deploy all the necessary means to facilitate the implementation of clinical trials; such could be the lessons to be learned from the current situation. For example, adaptability of protocols, shortening of the time required for instruction and compression of certain preliminary stages seem essential. At the same time, the expertise capacities of regulatory authorities must be strengthened so that no deviation can be made, the development of trials is justified and the results obtained are both usable and meaningful. Once the current crisis is over, it will be absolutely essential to formalize these lessons within national and European regulatory texts so that if such a situation is repeated, researchers and scientists will be able to collaborate on a common regulatory basis while being aware of the limits and possibilities specific to this context.
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Master Thesis
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Submitted on : Thursday, January 14, 2021 - 9:56:45 AM
Last modification on : Saturday, January 16, 2021 - 3:17:53 AM
Long-term archiving on: : Thursday, April 15, 2021 - 6:26:13 PM


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  • HAL Id : dumas-03109883, version 1


Léa Varenne. Méthodologie des essais cliniques : entre obligations réglementaires et urgence sanitaire. Sciences pharmaceutiques. 2020. ⟨dumas-03109883⟩



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