The Future of Contract Research Organizations in Dermatology and Aesthetic Research.

CRO clinical contract research organization dermatology investigator research trial

Journal

The Journal of clinical and aesthetic dermatology
ISSN: 1941-2789
Titre abrégé: J Clin Aesthet Dermatol
Pays: United States
ID NLM: 101518173

Informations de publication

Date de publication:
Dec 2022
Historique:
entrez: 2 1 2023
pubmed: 3 1 2023
medline: 3 1 2023
Statut: ppublish

Résumé

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. 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. 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. 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.

Identifiants

pubmed: 36588785
pmc: PMC9769583

Types de publication

Journal Article Review

Langues

eng

Pagination

S28-S31

Informations de copyright

Copyright © 2022. Matrix Medical Communications. All rights reserved.

Déclaration de conflit d'intérêts

DISCLOSURES: The authors report no conflicts of interest relevant to the content of this article.

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Auteurs

Mark Nestor (M)

Drs. Nestor and Santos are with the Center for Clinical and Cosmetic Research in Aventura, Florida.
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.

David Pariser (D)

Dr. Pariser is with Virginia Clinical Research, Inc., in Norfolk, Virginia.

James Del Rosso (J)

Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada, and Advanced Dermatology and Cosmetic Surgery in Maitland, Florida.

Dee Anna Glaser (DA)

Dr. Glaser is with the Department of Dermatology, Otolaryngology, and Internal Medicine at Saint Louis University School of Medicine in St. Louis, Missouri.

David Goldberg (D)

Dr. Goldberg is with Schweiger Dermatology Group in New York, New York.

Glynis Ablon (G)

Dr. Ablon is with the Ablon Skin Institute & Research Center in Manhattan Beach, California.

Z Paul Lorenc (ZP)

Dr. Lorenc is with the Lorenc Aesthetic Plastic Surgery Center in New York, New York.

Julie Santos (J)

Drs. Nestor and Santos are with the Center for Clinical and Cosmetic Research in Aventura, Florida.

Classifications MeSH