Publication:

Enhancing dermatology clinical trials: optimizing sites and strategies for success in India

India’s diverse patient population, cost-effective ecosystem and high prevalence of dermatological conditions like chronic inflammatory skin diseases, pigmentary disorders, alopecia and infectious diseases, etc. make it a prime destination for global clinical trials. This article is based on author’s experience in dermatology clinical research, web-based information from public domain including clinical trial registries, regulatory guidelines, review of literature, feasibility templates from sponsors and key industry conferences. It is the first of its kind to outline strategic approaches for optimizing dermatology clinical trial in India.  This paper recapitulates importance of advanced diagnostic tools, site setup, infrastructure, regulatory compliance, ethical governance and institutional ethics committee (IEC) in enhancing site’s credibility and attracting sponsors. Additionally, it highlights the research gaps in dermatology and provides a roadmap for sponsors, CROs and investigators aiming to conduct ethical, efficient and impactful dermatology trials in India. These insights aim to equip Indian dermatology sites to attract and manage high-quality clinical trials across all phases.