Mark Nestor1,2, David Pariser3, James Del Rosso4, Dee Anna Glaser5, David Goldberg6, Glynis Ablon7, Z Paul Lorenc8, Julie Santos1. 1. Drs. Nestor and Santos are with the Center for Clinical and Cosmetic Research in Aventura, Florida. 2. Dr. Nestor is additionally with the Department of Dermatology and Cutaneous Surgery,Department of Surgery, at the University of Miami, Miller School of Medicine in Miami, Florida. 3. Dr. Pariser is with Virginia Clinical Research, Inc., in Norfolk, Virginia. 4. Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada, and Advanced Dermatology and Cosmetic Surgery in Maitland, Florida. 5. Dr. Glaser is with the Department of Dermatology, Otolaryngology, and Internal Medicine at Saint Louis University School of Medicine in St. Louis, Missouri. 6. Dr. Goldberg is with Schweiger Dermatology Group in New York, New York. 7. Dr. Ablon is with the Ablon Skin Institute & Research Center in Manhattan Beach, California. 8. Dr. Lorenc is with the Lorenc Aesthetic Plastic Surgery Center in New York, New York.
Abstract
Objective: Dermatology and aesthetic medicine has experienced significant growth in recent years, driven by industry-sponsored research performed by clinical investigators. Contract research organizations (CROs) play an important role to ensure clinical trials are run efficiently, ethically, and according to Good Clinical Practice. An advisory group of dermatologists and aesthetic researchers was assembled to obtain feedback about CRO experiences for developing a "next-generation" specialty CRO for dermatology and aesthetic medicine. Methods: Experienced dermatologists and aesthetic physician researchers convened during the 2022 Winter Dermatology Annual Meeting in Kauai, Hawaii, to discuss experiences and make suggestions regarding CROs. Topics included positive and negative aspects of CRO experiences, desirable CRO services, and how CROs can be improved. Results: Benefits of working with CROs include project, data, and resource management and availability of technology. Desired functions include rapid study start-up, subject recruitment, and accurate and organized site-related documentation. Other qualities include access to large subject populations close to study locations, use of CRO-based clinical research assistants to support principal investigators across study sites, and scientific consultation, protocol development, medical writing, project management, clinical and medical monitoring, data management, biostatistics, and pharmacovigilance. Conclusion: CROs serve a vital role in the development process of drug, device, and therapeutics; however, it is important that changes to traditional CRO models are made to provide improved interactions with researchers in dermatology and aesthetic medicine.
Objective: Dermatology and aesthetic medicine has experienced significant growth in recent years, driven by industry-sponsored research performed by clinical investigators. Contract research organizations (CROs) play an important role to ensure clinical trials are run efficiently, ethically, and according to Good Clinical Practice. An advisory group of dermatologists and aesthetic researchers was assembled to obtain feedback about CRO experiences for developing a "next-generation" specialty CRO for dermatology and aesthetic medicine. Methods: Experienced dermatologists and aesthetic physician researchers convened during the 2022 Winter Dermatology Annual Meeting in Kauai, Hawaii, to discuss experiences and make suggestions regarding CROs. Topics included positive and negative aspects of CRO experiences, desirable CRO services, and how CROs can be improved. Results: Benefits of working with CROs include project, data, and resource management and availability of technology. Desired functions include rapid study start-up, subject recruitment, and accurate and organized site-related documentation. Other qualities include access to large subject populations close to study locations, use of CRO-based clinical research assistants to support principal investigators across study sites, and scientific consultation, protocol development, medical writing, project management, clinical and medical monitoring, data management, biostatistics, and pharmacovigilance. Conclusion: CROs serve a vital role in the development process of drug, device, and therapeutics; however, it is important that changes to traditional CRO models are made to provide improved interactions with researchers in dermatology and aesthetic medicine.
Authors: John G Muzic; Adam R Schmitt; Adam C Wright; Dema T Alniemi; Adeel S Zubair; Jeannette M Olazagasti Lourido; Ivette M Sosa Seda; Amy L Weaver; Christian L Baum Journal: Mayo Clin Proc Date: 2017-05-15 Impact factor: 7.616
Authors: Amanda Maisel; Abigail Waldman; Karina Furlan; Alexandra Weil; Kaitlyn Sacotte; Jake M Lazaroff; Katherine Lin; Diana Aranzazu; Mathew M Avram; Ashley Bell; Todd V Cartee; Alex Cazzaniga; Anne Chapas; Milene K Crispin; Jennifer A Croix; Catherine M DiGiorgio; Jeffrey S Dover; David J Goldberg; Mitchel P Goldman; Jeremy B Green; Charmaine L Griffin; Adele D Haimovic; Amelia K Hausauer; Shannon L Hernandez; Sarah Hsu; Omer Ibrahim; Derek H Jones; Joely Kaufman; Suzanne L Kilmer; Nicole Y Lee; David H McDaniel; Joel Schlessinger; Elizabeth Tanzi; Eduardo T Weiss; Robert A Weiss; Douglas Wu; Emily Poon; Murad Alam Journal: JAMA Dermatol Date: 2018-10-01 Impact factor: 10.282