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.
That percentage is an increase from 61% of Phase IV trials
that were voluntarily initiated by drug manufacturers in 2006.
In addition, the registry would be more beneficial if it were modified to include Phase III trials--the late stage trials of a drug that are conducted before it receives regulatory approval--and Phase IV trials
, which are conducted after the FDA has approved a medication.
Because of drug interactions involving switched products the FDA could someday require the equivalent of Phase IV trials
in which potential interactions would be studied.
Recognizing that clinical trial design is one of the most important and useful skills in the pharmaceutical industry, this book provides detailed discussions on a variety of statistical designs, their properties, and operating characteristics for phase I, II, and III clinical trials as well as an introduction to 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
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
Among different types of Phase IV trials
, the study found that on average, 30 percent of investigator initiated trials timelines are consumed by the patient recruitment process.
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.