Concept note :-

Title: In-depth analysis of phase four in pharma and post

marketing surveillance .

Scope:- Phase IV trial is also known as Post Marketing Surveillance Trial.

Phase IV trials involve the safety surveillance (pharmacovigilance) and
ongoing technical support of a drug after it receives permission to be sold.
Harmful effects discovered by Phase IV trials may result in a drug being no
longer sold, or restricted to certain uses: recent examples involve
cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and
rofecoxib (Vioxx).

Justification:- Phase 4 is the fastest-growing area of clinical research

today. At an annual growth rate of 23%, industry investment in post-
marketing research is expected to top $12 billion in 2007.
Post-marketing research is an important element of commercialization that
enables companies to expand existing markets, enter new markets, develop
and deliver messaging that directly compares their products with the
competition, and secure a niche position in crowded markets.