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 © 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=.08). 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=.04).
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. 2015;14(5):497-500.
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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,