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• W3135786340 abstract "To the Editor: Clinical trials are critical drivers in the field of medicine. Results from clinical trials improve our understanding and treatment of dermatologic conditions and are used to establish practice guidelines put forth by the organizations such as the American Academy of Dermatology.1Freeman E.E. McMahon D.E. Fitzgerald M. et al.Modernizing clinical practice guidelines for the American Academy of Dermatology.J Am Acad Dermatol. 2020; 82: 1487-1489Google Scholar Despite their importance, there have been limited analyses of dermatologic clinical trial characteristics and how they vary with disease burden, which may be used to inform research priorities. We analyzed dermatology clinical trials registered on ClinicalTrials.gov from October 1, 2007 to May 31, 2018 using the Aggregate Analysis of ClinicalTrials.gov database. Dermatologic trials were identified using Medical Subject Headings terms and condition-related terminology.2Wilmer E.N. Gustafson C.J. Ahn C.S. Davis S.A. Feldman S.R. Huang W.W. Most common dermatologic conditions encountered by dermatologists and nondermatologists.Cutis. 2014; 94: 285-292Google Scholar,3Lim H.W. Collins S.A.B. Resneck J.S. et al.The burden of skin disease in the United States.J Am Acad Dermatol. 2017; 76: 958-972.e2Google Scholar We extracted trial characteristics (Table I) and divided the analysis period into 2 intervals to assess temporal changes: October 1, 2007 through December 31, 2012 and January 1, 2013 through May 31, 2018. We also analyzed skin disease burden data in conjunction with clinical trial representation to assess the association of disease burden with the level of clinical trial activity. We obtained medical cost and mortality data for each disease from a prior analysis of a large claims database.3Lim H.W. Collins S.A.B. Resneck J.S. et al.The burden of skin disease in the United States.J Am Acad Dermatol. 2017; 76: 958-972.e2Google Scholar Two-sided Pearson χ2 test for the comparison of categorical variables and Spearman rank correlation to assess relationships between outcomes were performed using R (R Foundation, version 3.5.0).Table ICharacteristics of dermatology clinical trials registered on ClinicalTrials.gov between October 1, 2007 to December 31, 2012 and January 1, 2013 to May 31, 2018Clinical trial characteristicsTotalTime periodχ2 test2007-20122013-2018P valuePrimary objectiven (%)n (%)n (%) Basic science140 (2.3)49 (1.8)91 (2.6)<.001 Device feasibility5 (0.1)1 (0.0)4 (0.1) Diagnostic120 (1.9)37 (1.4)83 (2.4) Health services research36 (0.6)12 (0.4)24 (0.7) Other119 (1.9)18 (0.7)101 (2.9) Prevention336 (5.4)141 (5.2)195 (5.5) Screening24 (0.4)4 (0.1)20 (0.6) Supportive care126 (2.0)41 (1.5)85 (2.4) Treatment5307 (85.4)2384 (88.7)2923 (82.9)With a data monitoring committee Yes2010 (34.6)885 (35.0)1125 (34.3).623Trial phases Early Phase 184 (1.3)31 (1.1)53 (1.5)<.001 Phase 1747 (11.8)331 (12.0)416 (11.6) Phase 1/Phase 2396 (6.2)168 (6.1)228 (6.4) Phase 21659 (26.1)802 (29.0)857 (23.9) Phase 2/Phase 3147 (2.3)91 (3.3)56 (1.6) Phase 3965 (15.2)429 (15.5)536 (15.0) Phase 4672 (10.6)367 (13.3)305 (8.5) N/A1682 (26.5)549 (19.8)1133 (31.6)Number of arms 11924 (31.2)796 (30.5)1128 (31.6).086 22926 (47.4)1278 (49.0)1648 (46.2) ≥31322 (21.4)534 (20.5)788 (22.1)Number of enrollees 0-10643 (10.2)316 (11.5)327 (9.1)<.001 10-502703 (42.8)1218 (44.4)1485 (41.5) 50-1001123 (17.8)470 (17.1)653 (18.3) 100-5001478 (23.4)587 (21.4)891 (24.9) 500-1000255 (4.0)103 (3.8)152 (4.3) ≥1000120 (1.9)52 (1.9)68 (1.9)Blinding Double2049 (32.4)907 (33.0)1142 (31.9).561 Single3389 (53.6)1452 (52.8)1937 (54.2) None887 (14.0)390 (14.2)497 (13.9)Randomization Non-randomized2386 (38.4)970 (36.5)1416 (39.8).009 Randomized3835 (61.6)1689 (63.5)2146 (60.2)Primary Region North America3483 (54.8)1579 (57.0)1904 (53.1)<.001 Europe1713 (27.0)760 (27.5)953 (26.6) East Asia467 (7.4)145 (5.2)322 (9.0) Other902 (15.7)421 (16.5)481 (15.0)Number of geographic regions 15226 (90.9)2313 (90.7)2913 (91.0).715 2290 (5.0)138 (5.4)152 (4.7) ≥3235 (4.1)99 (3.9)136 (4.2)Funding source∗The sponsorship was categorized according to both the lead agency and partnering agencies involved in funding the trial. Industry3690 (58.1)1660 (60.0)2030 (56.6).003 National Institutes of Health279 (4.4)150 (5.4)129 (3.6) United States Federal Government32 (0.5)20 (0.7)12 (0.3) Other2351 (37.0)938 (33.9)1413 (39.4)The trial sponsorship was classified as “Industry” if the lead agency or if one of the partners for the trial was industry. The remaining trials were classified as “National Institutes of Health” if the lead agency or partner included the National Institutes of Health, otherwise they were classified as “Other.” Trials funded by the federal government (United States Federal Government) were separated from the National Institutes of Health category.∗ The sponsorship was categorized according to both the lead agency and partnering agencies involved in funding the trial. Open table in a new tab The trial sponsorship was classified as “Industry” if the lead agency or if one of the partners for the trial was industry. The remaining trials were classified as “National Institutes of Health” if the lead agency or partner included the National Institutes of Health, otherwise they were classified as “Other.” Trials funded by the federal government (United States Federal Government) were separated from the National Institutes of Health category. During the study period, 181,473 interventional trials were registered in ClinicalTrials.gov, of which 6352 (3.5%) were dermatology trials. The number of submitted dermatology trials per year increased from 540 in 2008 to 713 in 2017. Though the majority (70.8%) of trials enrolled <100 participants, the proportion of trials enrolling >100 participants increased between the 2 time periods (from 27.1% to 31.1%, respectively) (Table I). The proportion of National Institutes of Health-funded clinical trials decreased temporally (from 5.4% to 3.6%), with industry funding most of the dermatology clinical trials (60.0% and 56.6%). The proportion of trials per disease type did not change substantially (Table II). The medical cost of disease correlated moderately with the number of clinical trials (Spearman ρ = 0.51, P = .01), while disease mortality correlated strongly with the number of clinical trials (Spearman ρ = 0.72, P = .01).Table IIDermatologic conditions of clinical trials registered on ClinicalTrials.gov between October 1, 2007 to December 31, 2012 and January 1, 2013 to May 31, 2018Trial category∗For each candidate trial, we manually reviewed the official title and brief description to exclude trials not relevant to dermatology or skin diseases. The remaining trials were further categorized according to the disorder most relevant to the trial. Diseases of the hair, nails, lips, eyelids, external genitalia, and external ear were included as skin disease; skin damage from external cause and cutaneous manifestation of systemic diseases were included. Clinical trials focused on nonsurgical cosmetic and aesthetic interventions were also included as a separate category entitled “Cosmetics.” When appropriate, trials were assigned to >1 category and counted for each disease type. Trials that did not clearly match any category were marked “Other.”TotalTime period2007-20122013-2018Melanoma900 (12.7)414 (13)486 (12.5)Psoriasis768 (10.8)354 (11.1)414 (10.6)Ulcers556 (7.8)233 (7.3)323 (8.3)Atopic dermatitis489 (6.9)189 (5.9)300 (7.7)Wounds and burns395 (5.6)212 (6.7)183 (4.7)Acne and hidradenitis suppurativa383 (5.4)178 (5.6)205 (5.3)Cosmetics324 (4.6)160 (5)164 (4.2)Hair and nails301 (4.2)141 (4.4)160 (4.1)Cutaneous infections243 (3.4)136 (4.3)107 (2.7)Nonmelanoma skin cancer238 (3.4)104 (3.3)134 (3.4)Noncancerous skin growths224 (3.2)108 (3.4)116 (3)Autoimmune disorders218 (3.1)99 (3.1)119 (3)Viral and fungal infections207 (2.9)105 (3.3)102 (2.6)Actinic damage200 (2.8)77 (2.4)123 (3.2)Pruritus124 (1.8)51 (1.6)73 (1.9)Urticaria and angioedema111 (1.6)54 (1.7)57 (1.5)Pigmentary disorders110 (1.6)42 (1.3)68 (1.7)Rosacea105 (1.5)45 (1.4)60 (1.5)Congenital abnormalities100 (1.4)49 (1.5)51 (1.3)Molluscum and HPV related warts93 (1.3)38 (1.2)55 (1.4)Cutaneous lymphoma92 (1.3)37 (1.2)55 (1.4)Bullous diseases90 (1.3)35 (1.1)55 (1.4)Drug and radiation related reactions61 (0.9)28 (0.9)33 (0.8)Hyperhidrosis52 (0.7)14 (0.4)38 (1)Contact dermatitis44 (0.6)19 (0.6)25 (0.6)Seborrheic dermatitis41 (0.6)29 (0.9)12 (0.3)Other615 (8.7)231 (7.3)384 (9.8)HPV, Human papillomavirus.∗ For each candidate trial, we manually reviewed the official title and brief description to exclude trials not relevant to dermatology or skin diseases. The remaining trials were further categorized according to the disorder most relevant to the trial. Diseases of the hair, nails, lips, eyelids, external genitalia, and external ear were included as skin disease; skin damage from external cause and cutaneous manifestation of systemic diseases were included. Clinical trials focused on nonsurgical cosmetic and aesthetic interventions were also included as a separate category entitled “Cosmetics.” When appropriate, trials were assigned to >1 category and counted for each disease type. Trials that did not clearly match any category were marked “Other.” Open table in a new tab HPV, Human papillomavirus. There is heterogeneity in characteristics, methodology, and funding sources among dermatology clinical trials. Compared with other specialties, dermatology has proportionally fewer trials with >100 patients.4Califf R.M. Zarin D.A. Kramer J.M. Sherman R.E. Aberle L.H. Tasneem A. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010.JAMA. 2012; 307: 1838-1847Google Scholar Although smaller clinical trials may be appropriate in early-phase discovery interventions or dose/safety evaluations, they are less likely to be used to establish new standards of care.5Lurie J.D. Morgan T.S. Pros and cons of pragmatic clinical trials.J Comp Eff Res. 2013; 2: 53-58Google Scholar Industry sponsorship of clinical trials remains high in dermatology, and partnerships between the academic institutions and industry are likely to continue. We found significant associations between the medical cost of disease/mortality and clinical trial representation, and these metrics, although limited, may be helpful in designing future clinical trials. Study limitations include that ClinicalTrials.gov may not reflect the absolute number of clinical trials completed and that melanoma, though a dermatologic disease, is often included in trials studying multiple cancer types. Despite these limitations, our findings provide a framework to explore disease inclusion within dermatology clinical trials and the needs of our evolving patient population. Further studies are needed to assess the quality of these clinical trials and to identify strategies to increase the representation of underserved diseases. None disclosed." @default.
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• W3135786340 date "2022-03-01" @default.
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• W3135786340 title "Characteristics of dermatology clinical trials 2007-2018: Insights from a systematic analysis of ClinicalTrials.gov" @default.
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