Review Article
Dermatology 2020;236:375–382
Virtual Clinical Trials: Perspectives in
Dermatology
Zarqa Ali
a
John Robert Zibert
b
Simon Francis Thomsen
a, c
a
Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark;
b
LEO Innovation Lab, Copenhagen,
Denmark;
c
Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark
Received: August 6, 2019
Accepted after revision: February 10, 2020
Published online: March 3, 2020
Zarqa Ali, MD, PhD
Department of Dermatology, Bispebjerg Hospital
Bispebjerg Bakke 23
DK–2400 Copenhagen NV (Denmark)
zarqa_ali @hotmail.com
© 2020 S. Karger AG, Basel karger@karger.com
www.karger.com/drm
DOI: 10.1159/000506418
Keywords
Virtual clinical trials · Decentralized clinical trials · Remote
trials
Abstract
Background: The cost of developing a new drug is approxi-
mately USD 2.6 billion, and over two-thirds of the total cost
is embedded in the clinical-testing phase. Patient recruit-
ment is the single biggest cause of clinical trial delays, and
these delays can result in up to USD 8 million per day in lost
revenue for pharmaceutical companies. Further, clinical tri-
als struggle to keep participants engaged in the study and
as many as 40% drop out. To overcome these challenges
pharmaceutical companies and research institutions (e.g.,
universities) increasingly use an emerging concept: virtual
clinical trials (VCT) based on a remote approach. Summary:
VCT (site-less) are a relatively new method of conducting a
clinical trial, taking full advantage of technology (apps, mon-
itoring devices, etc.) and inclusion of web platforms (recruit-
ment, informed consent, counselling, measurement of end-
points, and any adverse reactions) to allow the patient to be
home-based at every stage of the clinical trial. Studies have
shown that VCT are not only operationally feasible, but also
successful. They have higher recruitment rates, better com-
pliance, lower drop-out rates, and are conducted faster than
traditional clinical trials. The visual nature of dermatological
conditions, the relative ease in evaluating skin diseases virtu-
ally, and the fact that skin diseases often are not life-threat-
ening and rarely require complex examinations make VCT
very attractive for dermatological research. Further, making
correct diagnoses based on photographs and patient symp-
tomatology has always been part of the dermatologist’s rou-
tine. Thus, VCT are in many ways made for dermatology.
Herein we describe VCT and their implications in dermato-
logical research. © 2020 S. Karger AG, Basel
Introduction
Clinical drug development is a time-consuming and
complex process that takes around 6–15 years [1]. The
cost of developing a new drug, from research and devel-
opment to marketing approval, is approximately USD 2.6
billion [2]. Approximately 85% of therapies fail through
early clinical development, and only half of those reach-
ing phase 3 are approved [3]. Over two-thirds of the total
cost, in both money and time, of the discovery and devel-
opment of a new drug is embedded in the clinical-testing
phase [4]. Patient recruitment is the single biggest cause
of clinical trial delays, and 30% of phase 3 study termina-