Key Topics Covered: The Emerging Role of Postmarketing Clinical Research Executive Summary Background to postmarketing research Mandatory postmarketing trial requirements Phase IV trials
for market development Impact of competitive pressures & pipeline strength on phase IV trials
Appropriate trial design CONTENTS: Chapter 1 Background to postmarketing research Chapter 2 Mandatory postmarketing trial requirements Chapter 3 Phase IV trials
for market development Chapter 4 Impact of competitive pressures and pipeline strength on phase IV trials
Chapter 5 Effective phase IV trial
design Chapter 6 Appendix FIGURES AND TABLES ALSO INCLUDED Products Mentioned: - Zyprexa - Diovan - Zoloft - Vioxx - Iressa - Novartis - Glivec (Imatinib mesylate) - Aclasta
In the next installment of Cancer: Conquering and Caring (December 2005), phase III and phase IV trials
will be discussed, as well as preventive studies.
There are several other reasons that drug companies may conduct Phase IV trials
The largest Phase IV outsourcing at a single company was 100 percent for its registries and observational trials; another company reported spending 10 percent or less for all types of Phase IV trials
Eamonn Hobbs, president and chief executive officer of Delcath System, said that the company believes these results show a strong signal of efficacy, and support the company's plan to initiate Phase III and Phase IV trials
for HCC in the second half of 2012.
But registries and observational trials are the most popular Phase IV trials
in Europe with 34 percent of post-marketing activity.
Win resource support: Match your needs to trial size and scope - compare planned versus actual spending and peruse staffing tables for 51 real- world Phase IV trials
Typically, the more expensive per-patient costs are for Phase IV trials
that study oncology or urology.
Pharmaceutical companies are seeking opportunities to reduce costs associated with drug development, and increasingly complex Phase IV trials
are driving market demand for technology which can cope with the demands of present and future clinical trials.
These Phase I through Phase IV trials
will focus on infectious diseases, including HIV, malaria and tuberculosis (TB).
The firm has managed and/or monitored Phase I through Phase IV trials
that have enrolled between 35 and 2,500 patients.
The CDR System is used throughout the drug development process, from first-in-man trials to large worldwide phase IV trials