Using the internet to enhance drug safety monitoring from phase 1 to phase 4 in dermatology clinical trials

Abstract

The monitoring of drug safety is one of the key events in pre- and postmarketing clinical trials. Often, safety signals are missed due to delays in gathering and interpreting safety data. It is not uncommon for there to be delays of weeks or more until case report form (CRF) data are collected from the field and entered into the database. When safety signals are missed, it may be too late to implement the corrective actions to maintain a drug in development and/or prevent product recalls and withdrawals. 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. The FDA has set up MedWatch to allow for the centralized reporting of adverse events over the Internet for the postmarketing environment. Now that the Internet and Web technology are being used to collect clinical trial data during the drug development process from Phase 1 to Phase 4, this same technology is probably the most cost-effective and time-effective ways that a company can monitor drug safety. The presentation will include a demonstration of this new technology, hints on implementing new programs, examples on how to gather and interpret data, and how to make FDA a partner in the process.