End points in dermatologic clinical trials: A review for clinicians.

Abstract:

:Clinical trials are critical for the development of new therapies in dermatology, and their results help determine US Food and Drug Administration (FDA) approval and guide care. Of special relevance is the clinical trial efficacy end point, the metric from which statistically significant outcome is derived. Clinicians' understanding of a clinical trial's end point is necessary for critical analysis of the trial results and for applying those results to daily practice. This review provides practical knowledge and critical evaluation of end points used in treatment approvals by the FDA. The end points for actinic keratosis, acne vulgaris, atopic dermatitis, onychomycosis, and cutaneous ulcer serve as examples.

journal_name

J Am Acad Dermatol

authors

Wei EX,Kirsner RS,Eaglstein WH

doi

10.1016/j.jaad.2016.01.052

subject

Has Abstract

pub_date

2016-07-01 00:00:00

pages

203-9

issue

1

eissn

0190-9622

issn

1097-6787

pii

S0190-9622(16)01317-7

journal_volume

75

pub_type

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