Three human studies, including 167 subjects, were designed to demonstrate the safety, efficacy and minimum effective dose of the Summers L.A. product.
Overall survival and other efficacy parameters show efficacy compared to historical controls, suggesting further study of micellar paclitaxel for the treatment of pancreatic cancer.
In order to speed up the process of data retrieval and evaluation, a specific Internet-based electronic data capture module was developed for pharmacokinetic and pharmacodynamic studies, allowing for rapid data entry, viewing and monitoring.
The use of Internet-based clinical trials can provide rapid access to clinical trial data, improve data quality and provide dramatic cost savings.
The presentation will include a demonstration of this new technology, some cost and benefit factors, hints on implementing new programs, examples on how to gather and interpret data, and how to make FDA a partner in the process.
The use of Internet-based clinical trials in single-center studies, such as a 200-subject sensitization/irritation study, and in multicenter studies such as acne, psoriasis and atopic dermatitis, can provide rapid access to clinical trial data as well as improved quality and dramatic cost savings.
Many drugs which have been evaluated for oral use may also have applications as topical therapies. As part of the “discovery” phase of drug development, companies interested in topical drug therapy should examine their libraries to identify drugs which already have toxicology and clinical data.
There is often a relatively large gap of time, between the time clinical trial data are collected and the time they are viewed and analyzed. In order to speed up the process of data retrieval, a specific Internet-based electronic data capture module has been developed for pharmacokinetic and pharmacodynamic studies, which allows for rapid data entry and monitoring.
When technically feasible, topical delivery of drug products for both local and systemic indications offer many advantages over the oral route.