The URMC Department of Dermatology has had a free-standing dermatology-focused Clinical Trials Unit (CTU) for over 15 years. The CTU space is contiguous with our major clinical facility on the Strong Memorial Hospital campus. This location was chosen to provide proximity to the CTSI, CRC, clinical laboratories, research pharmacy, full-service radiologic facilities and research laboratories. Our CTU employs a MD Director (with > 25 yrs of experience in NIH-funded, investigator and pharma/biotech initiated registries and interventional trials), administrator, two coordinators, NP coordinator, and a NY state-licensed MD co-investigator. In addition to these positions, the PI of each clinical trial is supported commensurate with their effort for that trial.
Currently five FT URMC Dermatology faculty are actively engaged in clinical trials. In the past five years we have completed or are currently enrolling for over 22 trials. We have met or exceeded our projected enrollment in > 85% of pharma-supported trials. We have broad expertise in a range of trial types from NIH- and Foundation-funded trials, multi-center trials (both Pharmaceutical and NIH-funded), Phase 1b-4 trials, registry studies, studies requiring IND exemptions, device testing, certificates of confidentiality as well as investigator-initiated trials. Our CTU is equipped with both standard equipment; Sphygmomanometer, ECG machine, Tympanic thermometer, tabletop centrifuge, temperature-monitored 4°C, -20°C and -80°C refrigerator/freezers as well as unique capabilities enabled by the Aquaflux® machine (closed unit to measure transepidermal water loss [TEWL]), Corneometer®CM 825 (to measure stratum corneum hydration), Skin-pH-Meter PH 905 (to measure skin pH); Cameras (Canon Powershot S3 and Nikon Coolpix S4), High Frequency Ultrasound (Longport and Cortex) with 20 and 50MHz probes to measure epidermal thickness and/or dermal inflammatory infiltrate and a Minolta Chromameter for measurement of erythema and pigment. We also have an infrared camera that can image surface heat. We have a platform to capture patient-reported and provider-reported outcomes on all patients. Patient-reported outcome (PRO) measures are administered in real-time on iPads during patient visits. These domain-specific PROs currently include PROMIS® measures (Pain Interference, Anxiety, Depression, and Itch) with the potential addition for Sleep domain. An additional provider-reported outcome assessment based on severity and response to treatment will be available in EMR flowsheet.