ABSTRACT
As the pharmaceutical industry strives to meet the ever-increasing complexity of drug development, new technology in clinical trials has become a beacon of hope. With big data comes the promise of accelerated patient recruitment, real-time monitoring of clinical trials, bioinformatics empowerment of quicker phase progression, and the overwhelming benefits of precision medicine for select trials. Risk-based monitoring stands to benefit as well. With a strengthening focus on centralized data by the FDA and industry's transformative initiative, TransCelerate, a new era in trial risk mitigation has begun. The traditional method of intensive on-site monitoring is becoming a thing of the past as statistical, real-time analysis of site and trial-wide data provides the means to monitor with greater efficiency and effectiveness from afar. However, when it comes to big data, there are challenges that lie ahead. Patient privacy, commercial investment protection, technology woes and data variability are all limitations to be met with considerable thought. At the Annual Meeting of the American Academy of Dermatology this year, clinical trials on psoriasis, atopic dermatitis and other skin diseases were discussed in detail. This review of clinical research reports on novel therapies for psoriasis and atopic dermatitis reveals the impact of these diseases and the drug candidates that have been successful in phase II and III studies. Data-focused highlights of novel dermatological trials, as well as real-life big data approaches and an insight on the new methodology of risk-based monitoring, are all discussed in this edition of Developments in Clinical Trials.
Subject(s)
Clinical Trials as Topic/methods , Drug Design , Drug Industry/methods , Computational Biology/methods , Dermatitis, Atopic/drug therapy , Dermatology/methods , Humans , Psoriasis/drug therapyABSTRACT
The pharmaceutical industry is experiencing change in ways it hasn't ever before. One topic at the center of all of these changes is the U.S. biosimilars market. This report will provide updates and changes associated with biosimilar regulations in the U.S. Additionally, the paper will identify requirements for success, and the likely early entrants in the U.S. market.
