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Translating Stem Cell Research: Challenges at the Research Frontier

Published online by Cambridge University Press:  01 January 2021

David Magnus
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Extract

There are many kinds of clinical trials. The regulatory framework within which most drug development takes place appears to be the one that is to be applied to the development of novel stem cell-based clinical trials. In the standard drug development model, appropriate pre-clinical research is conducted (largely based upon non-human animal models), and investigators or research sponsors (typically a company) submit an investigational new drug (IND) application to the Food and Drug Administration (FDA).

If approved, typical clinical trials start with Phase I, which is usually a trial (with a small number of participants) to determine the maximum tolerable dose of a drug. Phase I trials are often referred to as “safety studies” because the primary goal of Phase I research is to determine if an intervention is safe (not whether it works).

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 38 , Issue 2 , Summer 2010 , pp. 267 - 276
Copyright
Copyright © American Society of Law, Medicine and Ethics 2010

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