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皮肤科与美容研究领域合同研究组织的未来

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

作者信息

Nestor Mark, Pariser David, Del Rosso James, Glaser Dee Anna, Goldberg David, Ablon Glynis, Lorenc Z Paul, Santos Julie

机构信息

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.

出版信息

J Clin Aesthet Dermatol. 2022 Dec;15(12 Suppl 1):S28-S31.

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.

摘要

目的

近年来,在临床研究人员开展的行业资助研究的推动下,皮肤科和美容医学领域取得了显著发展。合同研究组织(CRO)在确保临床试验高效、合乎伦理且符合良好临床实践规范方面发挥着重要作用。组建了一个由皮肤科医生和美容研究人员组成的咨询小组,以获取有关CRO经验的反馈,从而为皮肤科和美容医学开发“下一代”专业CRO。

方法

经验丰富的皮肤科医生和美容医学研究人员于2022年在夏威夷考艾岛举行的冬季皮肤科年会上齐聚一堂,讨论有关CRO的经验并提出建议。主题包括CRO经验的积极和消极方面、理想的CRO服务以及如何改进CRO。

结果

与CRO合作的好处包括项目、数据和资源管理以及技术的可用性。理想的功能包括快速启动研究、招募受试者以及准确且有条理的与研究地点相关的文档。其他品质包括能够接触到靠近研究地点的大量受试者群体、利用基于CRO的临床研究助理支持各个研究地点的主要研究者,以及科学咨询、方案制定、医学写作、项目管理、临床和医学监测、数据管理、生物统计学和药物警戒。

结论

CRO在药物、器械和治疗方法的开发过程中发挥着至关重要的作用;然而,对传统CRO模式进行变革以改善与皮肤科和美容医学研究人员的互动非常重要。

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