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Written by leading experts in the field, Clinical Dermatology Trials 101 is the only clinical trial how-to available for dermatologists. With skin disease affecting nearly seventy percent of the population over a lifetime, and the rate of development of new drugs and devices for dermatologic use increasing at an exponential rate, there is a tremendous need for training and developing dermatology clinical research facilities to expedite the translation of basic and applied research, from bench to bedside.
This is useful for practicing dermatologists, academic dermatologists, dermatology residents, clinical research fellows, dermatology fellows, research scientists, industry dermatologists, and medical students.
Table of Contents
1 History and Background......................................................................... 1
Adnan Nasir
2 General Clinical Trials............................................................................ 21
Aída Lugo-Somolinos, Erika Hanami, and Matthew Overton
3 Dermatologic Clinical Trials: A Practical Approach............................ 47
Shalini V. Mohan and Anne Lynn S. Chang
4 Device Clinical Trials............................................................................... 59
Todd E. Schlesinger
5 Practical Tips............................................................................................ 73
Ella Grach
6 Budgets and Contracts............................................................................ 113
Ella Grach
7 Legal Issues Related to Human Subjects
for Research.............................................................................................. 135
Margarita S. Lolis and David J. Goldberg
8 Ethics......................................................................................................... 143
Kevin Yang, Anil Kurian, and Benjamin Barankin
9 Clinical Research in Pediatric Dermatology......................................... 161
Christine R. Totri and Lawrence F. Eichenfield
10 Statistics.................................................................................................... 177
Enzo Emanuele
11 Photography............................................................................................. 195
Adam Blechman and Anar Mikailov
12 The Regulatory Landscape..................................................................... 213
Adnan Nasir
13 Industry..................................................................................................... 231
Adnan Nasir
14 Societal Perspective.................................................................................. 247
Adnan Nasir
15 Opportunites in Clinical Research: Take the Initiative........................ 265
Adnan Nasir
Appendix........................................................................................................... 279
Glossary............................................................................................................ 321
Index.................................................................................................................. 331
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