Five-Year Trend in the Number of Dermatologic Clinical Drug Trials Registered on ClinicalTrials.gov
May 2015 | Volume 14 | Issue 5 | Original Article | 497 | Copyright © May 2015
Shivani S. Patel BS,a Karen E. Huang MS,a Alan B. Fleischer Jr. MD,a and Steven R. Feldman MD PhDa,b,c
aCenter for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC
bDepartment of Pathology, Wake Forest School of Medicine, Winston-Salem, NC
cDepartment of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC
BACKGROUND: There is a reported global decrease in the number of clinical trials conducted in recent years. We aimed to determine if
this declining trend can be extrapolated to dermatologic clinical trials.
METHODS: We conducted a query of ClinicalTrials.gov for dermatologic clinical trials from 2009 to 2013 for 6 common skin conditions: acne, psoriasis, rosacea, eczema
and atopic dermatitis, actinic keratosis,
and skin cancer.
Results were sorted by condition and number
of study subjects. This study did not involve any participants apart from the researchers.
RESULTS: Although there is an increasing trend in the number of trials performed annually, the results were not significant (P
The average number of patients per study has not significantly changed (P
=.12), but there was a significant increase in the number
of large studies (201+ subjects) conducted over time (P
=.002). Although there was significant variation based on dermatologic condition
studied (global statistic P=.01), only skin cancer demonstrated a significant change in the number of studies registered annually
(β=10.6 studies/year, P
CONCLUSIONS AND RELEVANCE: The sky does not appear to be falling, at least not yet, with regard to continued development of treatments
for patients with skin disease. J Drugs Dermatol.
Clinical trials are the cornerstone by which prevention
and therapy can be evaluated. Advancements in clinical
trials and the discovery of immunologically active
biologics provide a foundation for recent dermatologic therapeutics.
The collaboration between university researchers,
biotechnology companies, and pharmaceutical companies
initially led to a growth in clinical trials in the decades prior
to 2008.1 Recently, however, a new challenge exists in providing
novel and innovative therapies for patients, as only 1 in 5
drugs that enter clinical trials will eventually result in approval,
and even fewer enter the market.1,2 Clinical trials are now
dominated by smaller studies, and more than 50% of those
registered have fewer than 70 participants. This shifting trend
may also pose its own disadvantages, including difficulty with
extrapolation and treatment comparisons.3
Traditionally, clinical trials were carried out mostly in North
American and European countries. Recently, however, the
market shifted predominantly from Central Europe, the United
Kingdom, India, and North America to East Asia due to
the growing population, lower costs, and faster patient recruitment. 4-9 Similar trends were reported with dermatologic
publications and research in the UK, India, and Saudi Arabia. 10,11 In recent years, casual observation suggests a decline
in the number of dermatologic clinical trials.
ClinicalTrials.gov, launched in February 2000, is the largest
Web-based resource providing information to the public and
health professionals regarding clinical studies for a wide array
of conditions. Over 172,000 studies have been added since its
launch, encompassing over 187 countries and 98 million views
per month.12 Since the Food and Drug Administration Amendments
Act of 2007, the site expanded its mandated criteria for
trial reporting to include most non-phase 1 clinical trials and
updated submission of basic results.3,13,14 In this study, we aim
to analyze recent 5-year trends in the initiation of dermatologic
clinical trials using the ClinicalTrials.gov database.
A query of www.ClinicalTrials.gov was conducted between
July 31 2014 and August 4 2014 for 6 common skin conditions: acne, psoriasis, rosacea, eczema and atopic dermatitis,