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Translation from animal to clinical studies, choosing the optimal moment

We want to thank Davidson et al. for their comments and thoughts as reflected in their commentary, “When is a potential new neuroprotective treatment ready for translation?”, on our publication… Click to show full abstract

We want to thank Davidson et al. for their comments and thoughts as reflected in their commentary, “When is a potential new neuroprotective treatment ready for translation?”, on our publication concerning 2-iminobiotin following perinatal asphyxia. Their criticism focuses on the limited animal data of 2-iminobiotin as a neuroprotective compound in combination with therapeutic hypothermia (TH). They therefore recommend more animal studies before translation to human efficacy trials. Although the above-mentioned considerations are sound and understandable, an important issue may be overlooked here: direct translation from animal data to clinical care may not provide the ultimate answer! This is best illustrated with the development of TH itself, where depth of hypothermia and duration of this treatment was started on animal data, but clinical studies were necessary to “fine tune” the depth and duration in the clinical setting. Moreover, other compounds and drugs thought to be promising for add-on therapy for TH, such as rhEPO, allopurinol and several others, are not thoroughly and methodically tested along the lines as suggested by the authors of this editorial, but are now in phase II and III studies.

Keywords: clinical studies; animal clinical; translation animal; translation; animal data; studies choosing

Journal Title: Pediatric Research
Year Published: 2020

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